Table 1.

Descriptions of NCI Cooperative Group Phase III Treatment Trials That Stopped or Released Results Early for Positive Results, With Primary Publication Appearing Between 1990 and 2005

Trial Identifier (PDQ)	Trial Description and Reference Numbers*	Trial End Point†	Year Trial Was Stopped/Reported	% of Patients Accrued When Trial Stopped/Reported
NCCTG-844652	Phase III pilot of adjuvant therapy with levamisole v levamisole plus 5-fluorouracil for resectable adenocarcinoma of the colon7,8	OS	1989	100
RTOG-8501	Phase III comparison of radiotherapy alone v radiotherapy plus combination chemotherapy with CACP/FU in patients with localized carcinoma of the esophagus9,10	OS	1990	86
POG-9006	Phase III comparison of intensification with MP/MTX v alternating MP/MTX, VM-26/ARA-C, and DNR/ARA-C/VCR/PRED/PEG-ASP following induction with PRED/VCR/ASP/DNR in children with higher risk ALL11,12	CCR	1994	97
EST-3189	Phase III randomized comparison of CAF (CTX/ADR/FU) v a 16-week multidrug regimen (CTX/ADR/VCR/MTX/FU) as adjuvant therapy in node-positive patients with receptor-negative breast cancer13,14	OS	1994	100
CLB-9011	Phase III comparison of CLB v FAMP in previously untreated patients with intermediate- and high-risk (Rai stage I-IV) B-cell CLL15,16	CR	1995	100‡
SWOG-8892	Phase III study of radiotherapy with v without concurrent CDDP followed by CDDP/FU for previously untreated stage III/IV carcinoma of the nasopharynx17–19	PFS	1995	71
E-2491	Phase III randomized trial of tretinoin v ARA-C/DNR as induction therapy and of tretinoin v observation as maintenance therapy for patients with previously untreated promyelocytic leukemia20	DFS	1995	94
CCG-1882	Phase III treatment of poor-prognosis childhood ALL (excluding infants and patients with lymphoma-leukemia and FAB L3 blasts), including a randomized comparison of standard v augmented BFM in late responders21	EFS	1996	100
SWOG-8814	Phase III randomized comparison of adjuvant therapy with TMX v CAF (CTX/DOX/FU) plus concurrent or delayed TMX in postmenopausal women with node- and receptor-positive breast cancer22,23	DFS	1997	100
SWOG-8797	Phase III randomized comparison of radiotherapy with v without continuous-infusion FU/bolus CDDP after radical hysterectomy and node dissection in high-risk patients with stages IA2, IB, and IIA carcinoma of the cervix24,25	OS	1998	100
CLB-9344	Phase III randomized study of adjuvant cyclophosphamide/doxorubicin comparing standard- v intermediate- v high-dose doxorubicin, with v without subsequent paclitaxel, in women with node-positive breast cancer26–28	DFS	1998	100
RTOG-9001	Phase III comparison of pelvic irradiation with concurrent CDDP/5-FU v pelvic and para-aortic irradiation without chemotherapy in patients with high-risk carcinoma of the cervix29,30	OS	1998	100
CCG-5942	Phase III study of adjuvant low-dose involved-field radiotherapy v no adjuvant therapy in children with Hodgkin's disease in CR after chemotherapy assigned by clinical stage31	EFS	1998§	77
SWOG-9133	Phase III randomized trial of subtotal irradiation with v without DOX/VBL in patients with stage IA/IIA Hodgkin's disease32,33	FFS	2000	83
RTOG-9413	Phase III randomized study of whole pelvic irradiation followed by a cone-down boost to the prostate v prostate irradiation only and of neoadjuvant v adjuvant FLUT/ZDX for adenocarcinoma of the prostate34–36	PFS	2001	100
SWOG-S9701	Phase III randomized trial of 12 months v 3 months of paclitaxel in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer in complete remission after platinum/paclitaxel–based chemotherapy37,38	PFS	2001	66
NCCTG-N9741	Phase III randomized study of combinations of oxaliplatin, fluorouracil, leucovorin calcium, and irinotecan as initial therapy in patients with advanced adenocarcinoma of the colon and rectum39,40	PFS	2002	100
NCIC-MA17	Phase III randomized study of letrozole v placebo in postmenopausal women with primary breast cancer who have completed at least 5 years of adjuvant aromatase inhibitor41,42	DFS	2003	100
E-1496	Phase III randomized study of standard therapy followed by maintenance therapy with rituximab (IDEC-C2B8 monoclonal antibody) or observation in patients with stage III or IV low-grade non-Hodgkin's lymphoma43,44	PFS	2003	100
E-E1A00	Phase III randomized study of dexamethasone with or without thalidomide in patients with newly diagnosed multiple myeloma45,46	RR	2003	100
CCG-1961	Phase III randomized study of treatment based on response to induction chemotherapy in patients with higher risk childhood acute lymphocytic leukemia: standard v augmented BFM regimen with standard v prolonged intensification for rapid early responders and doxorubicin v idarubicin and cyclophosphamide with delayed intensification for slow early responders47,48	EFS	2003	100
E-3200	Phase III randomized study of oxaliplatin, fluorouracil, and leucovorin calcium with or without bevacizumab v bevacizumab only in patients with previously treated advanced or metastatic colorectal adenocarcinoma49–51	OS	2004	100
ECOG-2997	Phase III randomized study of fludarabine with or without cyclophosphamide in patients with previously untreated chronic lymphocytic leukemia52,53	CR	2004	100
NSABP-B-31/NCCTG-N9831	Phase III randomized study of doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab in women with node-positive breast cancer that overexpresses HER-2/Phase III randomized study of doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in women with HER-2–overexpressing node-positive or high-risk node-negative breast cancer54,55	DFS	2005	81
ECOG-4599	Phase II/III randomized study of paclitaxel and carboplatin with or without bevacizumab in patients with advanced, metastatic, or recurrent non–squamous cell non–small-cell lung cancer56	OS	2005	100
ECOG-2100	Phase III randomized study of paclitaxel with or without bevacizumab in patients with locally recurrent or metastatic breast cancer57,58	PFS	2005	100
NCIC-MA21	Phase III randomized study of adjuvant cyclophosphamide, epirubicin, and fluorouracil v cyclophosphamide, epirubicin, filgrastim (G-CSF), and epoetin alfa followed by paclitaxel v cyclophosphamide and doxorubicin followed by paclitaxel in premenopausal or early postmenopausal women with previously resected node-positive or high-risk node-negative stage I-IIIB breast cancer59,60	DFS	2005	100

Abbreviations: NCI, National Cancer Institute; NCCTG, North Central Cancer Treatment Group; OS, overall survival; RTOG, Radiation Therapy Oncology Group; CACP, cisplatin; FU, fluorouracil; POG, Pediatric Oncology Group; MP, mercaptopurine; MTX, methotrexate; VM-26, teniposide; ARA-C, cytarabine; DNR, daunorubicin; VCR, vincristine; PRED, prednisone; PEG, pegylated; ASP, asparaginase; ALL, acute lymphoblastic leukemia; CCR, continuous complete remission; CTX, cyclophosphamide; ADR, doxorubicin; CLB, chlorambucil; FAMP, fludarabine; CLL, chronic lymphocytic leukemia; CR, complete response; SWOG, Southwest Oncology Group; CDDP, cisplatin; PFS, progression-free survival; DFS, disease-free survival; CCG, Children's Cancer Group; FAB, French-American-British; BFM, Berlin-Frankfurt-Muenster; EFS, event-free survival; TMX, tamoxifen; DOX, doxorubicin; VBL, vinblastine; FFS, failure-free survival; FLUT, flutamide; ZDX, goserelin; NCIC, National Cancer Institute of Canada; RR, response rate; ECOG, Eastern Cooperative Oncology Group; NSABP, National Surgical Adjuvant Breast and Bowel Project; HER-2, human epidermal growth factor receptor 2; G-CSF, granulocyte colony-stimulating factor.

^*Reference numbers are given for references that were used to complete the trial information for Tables 1 to 3. Additional information on the trials was obtained from personal communications, as follows: EST-3189, E-1496, E-3200, ECOG-2997 (R.J. Gray, personal communication, July 2008); CLB-9011 (B. Peterson, personal communication, August 2008); SWOG-8892 (M. LeBlanc, personal communication, July 2008); SWOG-8814 (W. Barlow, personal communication, July 2008); SWOG-8797 (P.Y. Liu, personal communication, June 2008); RTOG-9001 (K. Winter, personal communication, July 2008); CCG-5942 (R. Sposto, personal communication, July 2008, of interim report on study 5942 prepared for the CCG Data and Safety Monitoring Committee, October 12, 1998); CCG-1961 (N.L. Seibel, personal communication, May 2008); and CCG-1882 (M. Devidas, personal communication, August 2008).

^†Complete definitions of the trial end points are given in Appendix Table A1.

^‡This is the percentage of the original target sample size; the primary end point was changed and the sample size was increased after the interim analysis when the results crossed the boundary in 1993. At that time, the percentage of accrual was 59%.

^§Random assignment stopped in 1998; as per protocol, results were reported later (2002).