White Pages - North Central Cancer Treatment Group

White Pages - North Central Cancer Treatment Group

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Table of Contents
Meeting Book Section
Paper Color
Future Meeting Dates
White
NCCTG Personnel
White
Executive Committee Members
Group Administrators
Nursing Board Cochairs
Clinical Research Associates Board
Patient Advocacy Chair
Research Base Scientific Coordinators
Statistical Personnel
Research Base Staff
Operations Office Personnel
Gastrointestinal Program Status Reports
Green
Breast Program Status Reports
Ivory
Lung Program Status Reports
Blue
Neuro-Oncology Program Status Reports
Gray
Miscellaneous Cancer Trials Status Reports
Pink
Cancer Control Program Status Reports
Lavender
Quality of Life
Goldenrod
Bibliography
White
Future Meeting Dates
2002 NCCTG fall meeting
October 8 - 11
Rochester, Minnesota
2003 NCCTG spring meeting
April 22-25
Rochester, Minnesota
2003 NCCTG fall meeting
October 7 - 10
Rochester, Minnesota
2004 NCCTG spring meeting
April 13 - 16
Rochester, Minnesota
2004 NCCTG fall meeting
September 28 - October 1
Rochester, Minnesota
Executive Committee Members
Committee Chairs
Executive Committee Chair
Executive Committee Vice Chair
Surgery Committee Chair
Pathology Committee Chair
Cancer Control Committee Chair
Radiation Oncology Committee Chair
Medical Oncology Committee Chair
Paul L. Schaefer, M.D.
Suresh Nair, M.D.
Ellison F. Kalda, II, M.D.
James Quesenberry, M.D.
Harold E. Windschitl, M.D.
Jeffrey S. Brindle, M.D.
Philip J. Stella, M.D.
Membership Principal Investigators
Ann Arbor PI
Bismarck PI
Carle PI
Cedar Rapids PI
Des Moines PI
Duluth PI
Fargo PI
Geisinger PI
Grand Forks PI
Mayo Clinic PI
Metro Minnesota PI
Missouri Valley PI
Ochsner PI
Peoria PI
Rapid City PI
Saskatchewan PI
Scottsdale PI
Sioux City PI
Sioux Falls PI
St. Cloud PI
Toledo PI
Wichita PI
Philip J. Stella, M.D.
Ferdinand K. Addo, M.D.
Kendrith M. Rowland, Jr., M.D.
Martin Wiesenfeld, M.D.
Roscoe E. Morton, M.D.
James E. Krook, M.D.
Ralph Levitt, M.D.
Suresh Nair, M.D.
Jeffrey S. Brindle, M.D.
Steven R. Alberts, M.D.
Patrick J. Flynn, M.D.
James A. Mailliard, M.D.
Carl G. Kardinal, M.D.
John W. Kugler, M.D.
Larry P. Ebbert, M.D.
Muhammad Salim, M.D.
Tom R. Fitch, M.D.
John C. Michalak, M.D.
Loren K. Tschetter, M.D.
Harold E. Windschitl, M.D.
Paul L. Schaefer, M.D.
Shaker Dakhil, M.D.
Group Administrators
NCCTG Chair
NCCTG Vice Chair
Program Directors
Treatment
Cancer Control
Radiation Quality Control Director
Statistician
Administrator
Administrator
Systems Coordinator
Administrative Secretary
Cancer Communications Coordinator
Breast
Cancer Control
GI
GU
Lung
Neurology
Oncology Nursing
Pathology
Radiation Oncology
Surgery
Novel Therapeutics
Quality of Life
Jan C. Buckner, M.D.
Heidi Nelson, M.D.
Charles Erlichman, M.D.
Charles L. Loprinzi, M.D.
Paula J. Schomberg, M.D.
Daniel J. Sargent, Ph.D.
Michael A. Pfenning, M.B.A.
Steven M. Evans
Sharon A. Elcombe, M.A.
Marilyn C. Kuhlmann
Mary Lawson
Research Base Scientific Coordinators
Edith A. Perez, M.D.
Paula J. Schomberg, M.D.
Charles L. Loprinzi, M.D.
Richard M. Goldberg, M.D.
James A. Martenson, Jr., M.D.
Patrick A. Burch, M.D.
James R. Jett, M.D.
Kurt A. Jaeckle, M.D.
Terrence L. Cascino, M.D.
Susan K. Quella, R.N.
Caterina Giannini, M.D.
Daniel W. Visscher, M.D.
Paula J. Schomberg, M.D.
Heidi Nelson, M.D.
John H. Donohue, M.D.
Claude Deschamps, M.D.
Charles Erlichman, M.D.
Jeff A. Sloan, Ph.D.
Nursing Board Cochairs
Susan Quella, R.N.
Wanda DeKrey, R.N.
Chair
Vice Chair
Secretary
Clinical Research Associates Board
Patrick Garoutte
Heather Burks
Cathie Smith
Patient Advocacy Chair
Wayland Eppard
Statistical Staff
Group Statistician
Daniel J. Sargent, Ph.D
Statisticians
Judith R. O’Fallon, Ph.D.
Jeff A. Sloan, Ph.D.
Vera J. Suman, Ph.D.
Susan P. Geyer, Ph.D.
Jake B. Allred, M.S.
Pamela J. Atherton, M.S.
Stephen S. Cha, M.S.
David W. Hillman, M.S.
Shauna L. Hillman, M.S.
Nancy Ituria, M.S.
Michelle R. Mahoney, M.S.
Matt Maurer, M.S.
Paul J. Novotny, M.S.
Data Analysts
Cristine Allmer
Ming-Wen An
Betsy Baker
Eric Bass
Mashele Blanch
Xiomara Carrero
Katherine A. Clement-Brown
Sara Felten
Alfred F. Furth
Leigh C. Gomez-Dahl
Erin Green
Britta J. Jasperson
Kathleen S. Tenner
Secretaries
Rhonda R. Larsen
Carol Stoecker
Systems Coordinator
Research Base Staff
Sharon A. Elcombe
Programming Unit
Supervisor
Lori A. Wangsness
Programmers
Protocol Development Unit
Supervisor
Ronald L. Anderson
Jon A. Barry
Steven W. Groslie
Kristina M. Hein
Mohammed N. Islam
Daniel A. Keller
Randi Riese
Bill J. Schaller
Jonathan D. Schmidt
Randall E. Stick
Jeannine Hadley
Protocol Development
Coordinators
Michelle K. Daiss
Sherry A. Foster
Colleen Garvey
Janis Gjervik
Patricia A. Mann
Jane M. Milburn
Sasha Nelson
Carol M. Schimek
Research Secretaries
Lyn K. Bolster
Michelle J. Bungum
Linda Floden
Debra P. Gardner
Janet M. Kundert
Charlotte M. McCann
Lois A. Ylvisaker
Vicki A. Bryhn
Renee L. Ewing
Sonja F. Hamilton
Rachael A. Rathmann
Barbara A. Warren
Data Systems Coordinators
NCCTG Operations Office Personnel
Randomization Specialists
Operational Support
Supervisor
Susan J. Jacobson
Carol J. Mahon
Diane M. Parkin
Marilyn C. Kuhlmann
Technical Data Coordinator
Sheree L. Estes
Secretaries
Kathleen S. Harding
Geraldine L. Lattimer
Clerks
Heidi L. Dahlgren
Judy A. Meyer
Rebecca S. Kuecker
Study Coordination Unit
Supervisor
Quality Control Specialists
Jennifer Darcy
Diane Amundson
Butch Kvittem
Victoria Anderson
Kris Brandt
Jennifer L. Frank
Linda Healy
Patricia Koenig, R.N.
Jennifer Schreiber
Carol A. Leonard
Kathleen A. Merkle
Kimberly Olson
Deborah J. Papenfus
Cindy S. Whitcomb
Serious Adverse Event Coordinator Patricia McNamara
Audit Coordinator
Linda S. Knowlton
Pathology Coordinator
Helen Tollefson
Radiation Coordinator
Kathryn M. Scherger
Data Entry
Julie Munsterman
NCCTG Statistical Unit Report
Studies: Table R1 summarizes the numbers of NCCTG-sponsored studies that were developed, activated, and/or
closed during each of the 4 years, 1998-2001, as classified according to their scientific goals. Study activity remained
fairly constant in 2001, with 20 protocols opening. The number of concepts and protocols decreased, but we expect
that this is a temporary phenomenon.
Table R1: Number of NCCTG-Sponsored Studies, Including NCCTG-Led
Intergroup Trials, Managed During 1998-2001
CONCEPTS REVIEWED
PROTOCOLS REVIEWED
STUDY CATEGORY
1998
1999
2000
2001
1998
1999
2000
2001
CANCER THERAPY
20
24
22
11
14
20
17
10
CANCER CONTROL
6
3
5
8
11
1
4
4
ANCILLARY
3
5
12
3
3
1
4
2
29
32
39
22
28
22
25
16
TOTAL
PROTOCOLS ACTIVATED
PROTOCOLS CLOSED
STUDY CATEGORY
1998
1999
2000
2001
1998
1999
2000
2001
CANCER THERAPY
18
19
17
20
12
21
14
24
CANCER CONTROL
9
4
4
6
1
7
4
4
ANCILLARY
10
8
13
19
8
11
9
9
37
31
34
45
21
39
27
37
TOTAL
Accrual: Table R2 summarizes accrual into NCCTG-sponsored trials during each of the 4 years, 1998-2001 as
classified according to their scientific goals. Accrual into cancer treatment trials has been steadily increasing over this
4-year period. 2001 was a very strong year for cancer control accrual. Note that the ancillary category includes the
translational research components in cancer therapy trials.
Table R2: Accrual into NCCTG-Sponsored Studies During 1998-2001
NCCTG
OTHER GROUPS
TOTAL
STUDY CATEGORY
1998
1999
2000
2001
1998
1999
2000
2001
1998
1999
2000
2001
CANCER THERAPY
1067
1289
1641
1821
397
374
852
1298
1464
1663
2493
3119
CANCER CONTROL
1102
839
339
1311
1202
230
0
82
2304
1069
339
1393
ANCILLARY
393
1275
414
926
142
86
144
614
535
1361
558
1540
2562
3403
2394
4058
1741
690
996
1994
4303
4093
3390
6052
TOTAL
The NCCTG Operations Office has had two areas of intense effort this past year, the Cancer Trials Support Unit
project and the challenges of adding a significant number of new staff.
Cancer Trials Support Unit - NCCTG personnel have been working with the NCI, Westat, and the Coalition of
Cooperative Groups on the Cancer Trials Support Unit project, better known as the CTSU. While this is a very large
project that includes significant changes in how we function, it will, in the long run, make many of the regulatory
requirements and daily data processing more streamlined and efficient. The upcoming changes that we will all need
to make will be a challenge, as change always is, but will eventually benefit clinical trials staff, investigators, and,
ultimately, the patients themselves.
Some of the current and upcoming changes include:
• The Pharmaceutical Management Branch (PMB) has modified its 1572 registration process to request more data
and has modified its database to include additional data. Very soon, all of the cooperative groups will access the
PMB data rather than requesting that same information from each physician. The PMB is also modifying its
systems to accommodate non-patient care physicians, e.g., pathologists, and all of the non-physician staff at each
treating location.
• Within the next year, all IRB approvals for participation in cooperative group trials will be sent to a centralized
CTSU location and entered into a centralized database. Each treating location will always send all cooperative
group study IRB approvals to this one location using one format. Watch for further updates.
• Eventually, the processes for registering patients onto studies, and the data capture itself, will become more
standardized and centralized.
Personnel: The challenge of being understaffed, hiring a sizeable number of new people, and the associated training
has stretched our current staff to the limit. In the past year, 26 individuals have joined us either in new or replacement
positions. While this increase in staff will benefit the NCCTG greatly, in the near term, training and a large number
of inexperienced staff will tax our system. The new staff are named below.
• Masters Statistician, Matt Maurer, joined the unit in January of 2002. Matt received his masters degree in Statistics
from Iowa State University in 2001. Matt is working with the neuro and lung programs.
• Winter 2002 found the addition of six data analysts to the statistics group, Ming An, Kathy Tenner, Betsy Baker,
Erin Green, Sara Felten, and Mashele Blanch. Ming is working with the breast and lung programs, Kathy with the
breast and GI programs, Betsy with cancer control and QOL, Erin with GI, Sara with neuro and hematology, and
Mashele with QOLl and Phase I. These additions have significantly increased the capacity of the statistics group
and are very welcome additions.
• Protocol Development: Carol Schimek and Sherry Foster joined the unit as protocol development coordinators in
Hematology. Char McCann returned to her research assistant role after a brief hiatus, Janet Kundert joined the unit
as a progress report secretary, and Lois Ylvisaker joined the group as a research assistant.
• Systems: Rachel Rathmann was hired as a data coordinator and facilitates forms and data entry screen development.
Mohammed Islam was hired as a programmer - his primary responsibility is the CTSU project. Lori Wangsness
replaced Susanne Daood as the Cancer Center Statistics Programmer Unit Head, as Susanne retired at the end of
2001.
• Quality Control Specialists: An offer has been extended for the QCS supervisor position. It is hoped that the
transaction will be finalized in the near future. Cindy Whitcomb has replaced Sandy Wilker, who retired at the end
of 2001. Diane Amundson came on board as a quality control specialist in the breast cancer program and Pat
McNamara is the new NCCTG SAE coordinator. Kris Bradt and Jennifer Schreiber have been hired to support the
breast cancer program. In addition, four individuals have joined the unit on a temporary basis.
• Randomization: One additional randomization specialist position was added and filled by Carol Mahon, a long time
Operations Office employee. Judy Meyer replaced Carol’s office assistant position.
North Central Cancer Treatment Group Administrative Report
Table 1
Status of All Currently Open Protocols
As of 02/18/2002
Site/Type
Ancillary
Breast
CNS
Cancer Control
Protocol Description
#
Total NCCTG NCCTG NCCTG NCCTG
Proj. Cases Overall
Total
Past 6 Past 12
Cases Accrued Accrual Excluded Months Months
49808
BREAST/4AC/TAXOL/HER
400
1
0
0
0
0
80696
FAMILIAL COLORECTAL
5000
343
200
0
0
0
934655
LAB STUDY DUKES B AN
700
574
574
0
1
66
942054
LAB STUDY MICROSATEL
240
98
98
0
0
0
969252
BREAST DZ IN INDIAN
1000
1458
0
0
0
0
98-13
AA RT/TMZ/BCNU
585
29
0
0
0
0
984654
8P COLORECTAL CANCER
560
598
517
4
0
2
989254
SURVEY ORAL CRYOTHER
100
1
0
0
0
0
MA.17L
BREAST - LIPID COMPA
300
291
42
0
25
40
MA17B
BREAST/LETROZOLE
200
110
23
0
16
23
N0037
HER1/FISH/PACLITAXEL
40
4
4
0
0
4
N0045
RECORD STUDY/GI/RECT
3820
1
0
0
0
0
N0076
HIGH-GRADE GLIOMA/CO
1200
1
0
0
0
0
N007D
VALIDATE MEASURE MET
150
86
86
0
86
86
N0093
GASTRIC/GLIOMA/TOPOI
99999
17
17
0
17
17
N0144
PROFILE SURVIVORS CO
45
1
0
0
0
0
N0148
DATA BASE/COLON CANC
3351
1
0
0
0
0
N9924
LUNG/ META-ANALYSIS
2756
1
0
0
0
0
N994C
COLORECTAL/TRANSLATI
0
1
0
0
0
0
49907
BREAST - CMF/AV/CAPC
1800
1
0
0
0
0
983252
TAXOL/CBDCA/RHUMAB H
92
54
54
1
15
25
983253
METASTATIC BREAST/MT
50
17
17
0
11
16
E5194
BREAST LOCAL EXC.DCI
1176
577
108
0
17
28
MA17
BREAST LETROZOLE VS
4800
4148
317
1
74
154
N0032
METASTATIC BREAST/FA
94
22
22
0
17
22
N003A
ORAL VINORELBINE/BRE
35
2
2
0
2
2
N9831
BREAST - AC/TAXOL/HE
3000
873
152
0
58
106
N9932
DOCETAXEL/CBDCA BREA
55
47
47
0
27
43
S9927
BREAST POSTMASTECTOM
2500
29
2
0
1
2
9402
RT VS PRE-RT PCV CNS
292
297
31
0
2
5
947252
LAB STUDY BRAIN
328
328
0
12
33
947253
LAB STUDY - BRAIN SI
99999
135
135
1
0
0
967351
PCNSL RT + HD CORTIC
28
15
15
0
2
6
98-02
PCV CHEMO IN LOW GRA
288
329
33
0
4
9
987254
PHII PZA+CBDCA / GLI
68
14
14
0
4
8
N0074
GLIOBLASTOMA/ZD1839
93
57
57
0
40
57
N997B
GLIOBLASTOMA CCI-779
37
9
9
0
8
9
969251
SKIN CANCER CHEMOPRE
110
3
3
0
0
2
9714
SOLID TUMOR/BONE MET
1080
825
38
0
4
9
North Central Cancer Treatment Group Administrative Report
Table 1
Status of All Currently Open Protocols
As of 02/18/2002
Site/Type
GI
GU
Hematology
Lung
Mesothelioma
Protocol Description
#
Total NCCTG NCCTG NCCTG NCCTG
Proj. Cases Overall
Total
Past 6 Past 12
Cases Accrued Accrual Excluded Months Months
989251
CERVICAL IMIQUIMOD C
154
35
35
1
5
13
989255
MEGACE VS EPA
450
345
274
4
53
137
E5597
LUNG SELENIUM CHEMOP
1960
173
14
0
6
14
MC9944
FECAL BLOOD VS. EXAC
4000
179
115
0
115
115
N00C3
NEUROPATHY/GABAPENTI
100
1
0
0
0
0
N00CB
HOT FLASHES/GABAPENT
220
2
2
0
2
2
N99C4
INHALER SMOKING CESS
1600
1247
1247
0
1066
1247
N99C5
DONEPEZIL SMALL CELL
104
3
3
0
3
3
9581
ADJ ACA COLON MOAB17
2100
1598
238
0
20
43
964152
PH II CPT-11 GASTRIC
66
67
67
1
5
14
N0041
HEP CARCINOMA/GEMZAR
44
7
7
0
7
7
N0042
BILIARY TRC CARC/PH
45
37
37
0
23
37
N0044
ESOPHAGEAL/CHEMO+RT
60
0
0
0
0
0
N0048
COLORECTAL/OXAL/CPT-
80
9
9
0
8
9
N9741
ADVANCED COLON CPT11
1705
1298
443
11
91
129
N9841
ADV COLORECTAL CPT-1
560
320
173
0
26
60
N9942
PANCREAS CA GEMCITAB
46
9
9
0
9
9
R9811
ANAL CANAL 5FU MITO-
650
293
16
0
6
9
N0052
PROS/Brachytherapy
83
1
0
0
0
0
N9953
GM-CSF - RENAL CELL
48
27
27
3
0
5
S9916
PROSTATE/TATER-ESTRA
220
539
50
0
11
25
988152
PH II GEMCITABINE/LE
30
17
17
3
5
11
N0087
NHL/INTERLEUKIN-12/R
90
9
9
0
9
9
N9981
LYMPHOMA-DHAP + RITU
55
29
29
0
11
25
N9982
MMM/THALIDOMIDE
43
26
26
0
10
13
N9986
CLL-THALI
41
14
14
0
1
9
N998B
THALI/MDS
50
69
69
1
49
69
9633
NSCLC STAGE I NEOADJ
500
272
32
0
5
9
972051
SCLC TOPA TAXOL
110
83
83
0
16
26
972451
NSCLC CAI STAGE IIIB
360
109
109
0
20
39
N0022
NSCLC/ORAL VINORELBI
55
54
54
0
40
54
N0026
NSCLC/GEMCITABINE/AL
180
24
24
1
24
24
N0027
SCLC/TOPOTECAN/CARBO
49
5
5
0
5
5
N9923
LUNG CDDP/VP16/ETHYO
50
7
7
0
4
7
S0023
NSCLC/CISPLATIN/ETOP
840
26
5
0
5
5
S9900
NSCLC SURG/TAXOL/CBD
600
191
52
0
17
41
N0021
MESOTHELIOMA/GEMZAR
40
16
16
0
14
16
North Central Cancer Treatment Group Administrative Report
Table 1
Status of All Currently Open Protocols
As of 02/18/2002
Site/Type
Multiple
Other
Protocol Description
971151
SHARK CARTILAGE
SMOKING
SMOKING TEST STUDY
#
Total NCCTG NCCTG NCCTG NCCTG
Proj. Cases Overall
Total
Past 6 Past 12
Cases Accrued Accrual Excluded Months Months
600
22
22
1
22
22
137
137
0
43
137
North Central Cancer Treatment Group Administrative Report
Table 2
Credits
As of 02/18/2002
Site/Type
Ancillary
Breast
NCI
NCI NCCTG
NCCTG
Rx
CC
Ancilary Tissue Bank
Protocol Credits Credits Credits
Credits
49808
0.0
0.0
1.0
0.0
80696
0.0
0.0
0.0
0.0
934655
0.0
0.0
1.0
0.0
942054
0.0
0.0
1.0
0.0
9633
0.0
0.0
0.0
0.0
964152
0.0
0.0
0.0
66
969252
0.0
0.0
0.0
0.0
972451
0.0
0.0
1.0
0.0
98-13
0.0
0.0
0.0
0.0
984654
0.0
0.0
1.0
0.0
989254
0.0
0.0
0.0
0.0
989255
0.0
0.0
0.0
31
MA.17L
0.0
0.0
1.0
0.0
MA17B
0.0
0.0
1.0
0.0
N0032
0.0
0.0
1.0
20
N0037
0.0
0.0
0.0
4.0
N003A
0.0*
0.0*
0.0
1.0
N0045
0.0
0.0
0.0
0.0
N0074
0.0
0.0
1.0
20
N0076
0.0
0.0
0.0
0.0
N007D
0.0
0.0
0.0
0.0
N0087
0.0
0.0
0.0
0.0
N0093
0.0
0.0
1.0
0.0
N0144
0.0
0.0
0.0
0.0
N0148
0.0
0.0
0.0
0.0
N9831
0.0
0.0
0.0
709
N9924
0.0
0.0
0.0
0.0
N9932
0.0
0.0
1.0
0.0
N994C
0.0
0.0
0.0
0.0
N997B
0.0
0.0
2.0
0.0
N9982
0.0
0.0
1.0
0.0
N9986
0.0
0.0
0.0
14
N998B
0.0
0.0
1.0
0.0
49907
0.0
0.0
0.0
0.0
983252
1.0
0.0
0.0
0.0
983253
1.0
0.0
0.0
0.0
E5194
1.1
0.0
0.0
0.0
* NCCTG estimated pending NCI case credit assignment
North Central Cancer Treatment Group Administrative Report
Table 2
Credits
As of 02/18/2002
Site/Type
NCI
NCI NCCTG
NCCTG
Rx
CC
Ancilary Tissue Bank
Protocol Credits Credits Credits
Credits
MA17
1.0
0.5
0.0
0.0
S9927
1.0
0.0
0.0
2.0
9402
1.0
0.0
0.0
0.0
947252
0.1
0.0
0.0
0.0
947253
0.1
0.0
0.0
0.0
967351
1.0
0.0
0.0
0.0
98-02
1.0
0.0
0.0
0.0
987254
1.0
0.0
0.0
0.0
969251
0.0
1.0
0.0
0.0
9714
0.0
0.7
0.0
0.0
E5597
0.0
1.0
0.0
0.0
MC9944
0.0
0.8
0.0
0.0
N00C3
0.0
0.7
0.0
0.0
N00CB
0.0
0.5
0.0
0.0
N99C4
0.0
1.0
0.0
0.0
N99C5
0.0
0.5
0.0
3.0
9581
1.1
0.0
1.0
0.0
N0041
1.0
0.0
0.0
0.0
N0042
1.0
0.0
0.0
0.0
N0044
1.0*
0.0*
0.0
0.0
N0048
1.0
0.0
0.0
0.0
N9741
1.0
0.3
0.0
256
N9841
1.0
0.5
0.0
0.0
N9942
1.0
0.0
0.0
0.0
R9811
1.0
0.0
0.0
0.0
N0052
1.0*
0.0*
0.0
0.0
N9953
1.0
0.0
1.0
0.0
S9916
1.0
0.0
0.0
0.0
GYN
989251
0.0
0.0
0.0
0.0
Hematology
988152
1.0
0.0
0.0
0.0
N9981
1.0
0.0
0.0
0.0
972051
1.0
0.0
0.0
0.0
N0022
1.0
0.5
0.0
0.0
N0026
1.0
0.0
0.0
0.0
N0027
1.0*
0.0*
0.0
0.0
N9923
1.0
0.0
0.0
0.0
S0023
1.0
0.0
0.0
0.0
CNS
Cancer Control
GI
GU
Lung
* NCCTG estimated pending NCI case credit assignment
North Central Cancer Treatment Group Administrative Report
Table 2
Credits
As of 02/18/2002
Site/Type
NCI
NCI NCCTG
NCCTG
Rx
CC
Ancilary Tissue Bank
Protocol Credits Credits Credits
Credits
S9900
1.0
0.0
0.0
0.0
Mesothelioma
N0021
1.0
0.0
0.0
0.0
Multiple
971151
0.5
0.5
0.0
0.0
SMOKING
0.0
0.0
0.0
0.0
Other
* NCCTG estimated pending NCI case credit assignment
North Central Cancer Treatment Group Administrative Report
Table 3
Year To Date Experience On NCCTG Sponsored Studies
NCCTG Credit System
As of 02/19/2002
Membership
Treatment Cancer Control
Credits
Credits
Ancillary Tissue Bank
(30 Needed) (10 Needed)
Credits
Credits
Ann Arbor
11.0
12.8
3
6
Bismarck
5.0
47.0
0
0
Carle
7.6
37.8
3
2
Cedar Rapids
8.1
5.5
1
3
Des Moines
12.1
12.3
4
4
Duluth
21.7
7.8
5
9
Fargo
13.1
1.8
2
2
Geisinger
11.0
66.2
3
1
Grand Forks
2.0
5.3
0
2
Howard
0.0
19.0
0
0
Jacksonville
10.1
0.5
1
0
Mayo
35.2
29.4
27
8
Metro
9.0
0.3
2
2
Mo Valley
22.1
8.8
5
7
Ochsner
4.0
5.0
1
0
Peoria
17.0
59.1
5
6
Rapid City
1.1
0.0
0
0
Saskatchewan
10.0
0.9
2
3
Scottsdale
13.1
5.0
3
1
Sioux City
3.0
0.0
1
0
Sioux Falls
4.2
10.0
0
2
St. Cloud
5.1
1.5
3
0
Toledo
5.0
10.0
1
0
Wichita
18.5
64.0
1
7
North Central Cancer Treatment Group Administrative Report
Table 4
Total Case Credits by Month
For NCCTG Memberships
02/19/2001 to 02/19/2002
Month
NCCTG
NCCTG
Treatment Cancer Control Ancillary Tissue Bank
Year Credits
Credits
Credits
Credits
March
2001
161.1
37.9
27
32
April
2001
154.6
41.7
60
34
May
2001
127.8
35.8
55
37
June
2001
143.9
36.4
51
14
July
2001
149.3
148.4
38
25
August
2001
163.9
162.8
39
22
September
2001
157.6
121.1
52
21
October
2001
176.5
209.9
48
29
November
2001
183.9
342.6
48
28
December
2001
132.1
221.5
23
20
January
2002
170.9
192.6
43
44
February
2002
131.2
236.7
38
31
North Central Cancer Treatment Group Administrative Report
Table 5
Total NCCTG Case Credits
For NCCTG Memberships
02/19/2001 to 02/19/2002
Membership
Treatment Cancer Control
Credits
Credits
Ancilary Tissue Bank
(30 Needed) (10 Needed)
Credits
Credits
Ann Arbor
46.0
79.4
19.0
17.0
Bismarck
60.7
139
16.0
11.0
Carle
93.8
142
24.0
21.0
Cedar Rapids
82.4
91.3
16.0
19.0
Des Moines
102
105
33.0
13.0
Duluth
67.9
42.0
16.0
24.0
Fargo
77.9
88.5
19.0
13.0
Geisinger
60.0
144
14.0
6.0
Grand Forks
17.2
28.2
2.0
5.0
Howard
0.0
19.0
0.0
0.0
Jacksonville
13.1
0.5
1.0
0.0
Mayo
320
128
138
47.0
Metro
52.0
2.7
12.0
17.0
Mo Valley
151
51.3
30.0
24.0
Ochsner
35.0
59.0
16.0
1.0
Peoria
106
116
34.0
13.0
Rapid City
28.1
63.7
8.0
6.0
Saskatchewan
59.9
48.3
20.0
14.0
Scottsdale
125
44.8
33.0
20.0
Sioux City
50.1
91.5
21.0
7.0
Sioux Falls
40.2
91.9
8.0
5.0
St. Cloud
33.8
7.4
13.0
2.0
Toledo
74.3
14.6
13.0
8.0
Wichita
139
184
16.0
44.0
North Central Cancer Treatment Group Administrative Report
Table 6
Current Status of Protocols Closed Within Last 12 Months
As of 02/19/2002
Site/
Type
Protocol Description
Date
Activated
NCCTG NCCTG
Date Overall
Total
Closed Accrual Excluded
Ancillary
934653
COLON CA LAPAROSCOPIC-ASSIST
08/02/1994
08/31/2001
156
1
Breast
N9431
BREAST SURG RX/MENSTRUAL CYC
07/12/1996
12/31/2001
185
21
E1199
BREAST AC +/- TAXOL TAXOTERE
10/15/1999
01/08/2002
486
0
963255
REFRACTORY MET BREAST CPT-11
09/25/1998
11/23/2001
104
1
E2196
MET BREAST MARIMASTAT
08/13/1999
06/13/2001
7
0
N0031
BREAST CANCER/TOPICAL CERAMI
05/18/2001
10/05/2001
26
1
CNS
987251
ASTROCYTOMA-BCNU,CISPLAT,ETO
02/12/1999
04/13/2001
29
0
Cancer Control
979252
BLADDER MEGADOSE VIT.
10/29/1999
09/28/2001
21
0
979251
LMWH ADVANCED CA
12/04/1998
06/29/2001
141
3
979253
RHUEPO/ANEMIA PTS WITH CANCE
12/04/1998
09/28/2001
344
14
989201
ADV CA ONDANSETRON DB
10/20/2000
09/28/2001
5
0
N9941
TAXOTERE/CPT-11 IN ESOPHAGUS
04/21/2000
11/16/2001
47
1
964352
GEMCITABINE/CISPLAT/RT/PANCR
02/24/1998
08/10/2001
26
0
964252
CPT11 IN GALLBLADDER/BILE DU
03/27/1998
03/16/2001
39
4
974651
UNRES LIVER METS/OXAL/5FU/CF
03/26/1999
08/31/2001
44
1
950452
DNA PARAFFIN BLOCKS COLON
12/04/1998
01/25/2002
412
0
984652
PELVIC CA CAPECITABINE
04/09/1999
11/01/2001
10
0
CALGB898
HIGH-RISK COLON,CPT-11,5FU,C
06/11/1999
05/15/2001
301
0
N9946
COLORECTAL ACA OXAL 5-FU CF
04/13/2001
11/30/2001
48
0
N0043
PANCREATIC GEMZAR ISIS 2503
02/16/2001
11/27/2001
48
0
GU
N9951
GREEN TEA PROSTATE
12/29/2000
06/01/2001
54
10
Hematology
987851
RITUXAN/NON-HODGKINS LYMPHOM
07/12/1999
05/18/2001
39
0
9732
EXT SCLC VP16/CDDP/TAXOL
10/30/1998
07/13/2001
70
0
9309
RT/CHEMO/SURGERY NSCLC
08/09/1996
10/24/2001
11
0
982453
NSCLC CPT11 TAXOTERE
10/08/1999
04/06/2001
48
0
N9975
MET MELANOMA LUNG_GM-CSF
09/29/2000
02/08/2002
28
0
GI
Lung
Melanoma
North Central Cancer Treatment Group Administrative Report
Table 7
Intergroup Studies Where NCCTG is the Data Center
Monthly Case Accrual
As of 02/19/02
Protocol
Randomizing Past 3 Past 6 Past 9 Past 12
Total
Overall
Group
Months Months Months Months Excluded Accrual
972451
CTSU
0
0
0
0
0
0
EPP
0
0
2
3
0
8
984654
NCCTG
9
19
30
39
0
109
Total
9
19
32
42
0
117
NCCTG
0
0
0
2
4
517
NCIC CTG
0
0
0
18
0
81
Total
989255
N9741
0
0
0
20
4
598
NCCTG
30
48
93
138
4
275
NCIC CTG
11
29
49
70
0
71
Total
41
77
142
208
4
346
CALGB
27
51
53
89
4
343
ECOG
47
85
86
121
4
222
2
7
9
12
0
58
NCCTG
36
85
96
129
11
443
NCIC CTG
17
22
22
55
2
127
SWOG
35
52
53
84
2
168
EPP
Total
N9831
164
302
319
490
23
1361
CALGB
33
91
127
182
0
215
ECOG
55
109
172
220
0
268
EPP
N9841
0
0
0
0
0
0
NCCTG
30
52
82
106
0
152
SWOG
34
90
143
191
1
242
Total
152
342
524
699
1
877
ECOG
6
11
13
17
0
17
EPP
1
1
3
4
0
10
NCCTG
13
25
42
61
0
174
SWOG
17
36
54
77
3
130
Total
37
73
112
159
3
331
RADIATION QUALITY CONTROL REPORT BY NCCTG MEMBERSHIP
ELIGIBLE CASES ON STUDY WITHIN LAST 5 YEARS WITH
A REVIEW COMPLETED WITHIN THE LAST 12 MONTHS
AS OF 12/31/2001
1997-2001
Membership
2001
Total % Minor % Major
Cases Deviations Deviations
Cases
# Minor
# Major
Reviewed Deviations Deviations
Ann Arbor
13
38.5
0.0
0
0
0
Bismarck
20
25.0
0.0
4
1
0
Carle
23
8.7
13.0
3
0
2
Cedar Rapids
25
16.0
4.0
3
0
0
Des Moines
40
15.0
5.0
5
0
0
Duluth
34
23.5
14.7
1
0
1
Fargo
25
20.0
4.0
1
0
0
Geisinger
20
20.0
5.0
3
0
1
Grand Forks
14
7.1
7.1
1
0
0
Mayo
106
6.6
7.5
10
1
2
Metro
11
18.2
9.1
5
0
1
Mo Valley
36
27.8
5.6
4
2
0
Ochsner
6
33.3
0.0
1
0
0
Peoria
37
18.9
29.7
5
3
1
Rapid City
23
0.0
0.0
0
0
0
Saskatchewan
4
50.0
25.0
0
0
0
Scottsdale
20
20.0
10.0
3
1
0
Sioux City
14
14.3
14.3
2
0
1
Sioux Falls
17
23.5
11.8
2
0
0
St. Cloud
17
29.4
5.9
3
1
0
Toledo
23
34.8
13.0
3
1
0
Wichita
7
0.0
14.3
3
0
1
535
17.4
9.0
62
10
10
Total