Type(s) of Cancer
Colorectal
Colorectal
Study Phase
Phase 3
Study Completion Date
November 2012
November 2012
NCT00079274Uploaded 08-10-2017
Available for Download
PDS UID: Colorec_Allianc_2004_161
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer
Provider Information
Provider Data DescriptionPrimary Objective: To compare the disease-free survival (DFS) in patients with stage III
(TxN1-2M0) colon cancer who are KRAS wild-type randomized to 24
weeks of adjuvant chemotherapy with either: (1) Oxaliplatin (OXAL) +
5-fluorouracil/leucovorin (5-FU/LV) (FOLFOX) or (2) FOLFOX + C225.
Secondary Objectives:
I. To compare the DFS in unselected patients with stage III (TxN1-2M0)
colon cancer randomized to 24 weeks of adjuvant chemotherapy with
either: (1) Oxaliplatin (OXAL) + 5-fluorouracil/leucovorin (5-FU/LV)
(FOLFOX) or (2) FOLFOX + C225.
II. To compare the overall survival (OS) in patients with KRAS wildtype
tumors, and in unselected patients with stage III (Tx, N1-2, M0)
colon cancer randomized to 24 weeks of adjuvant chemotherapy
with FOLFOX with or without C225.
III. To assess toxicities resulting from the addition of C225 to chemotherapy.
IV. To compare the quality of life, measures of patient satisfaction,
nutrition, and cancer risk in patients treated with FOLFOX with
or without C225, using four patient-completed questionnaires.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderAlliance for Clinical Trials in Oncology
Partial set or SubsetOriginal Data
Patients in dataset3397
# of Patients Control1337
# of Patients Experimental1631
DOIhttps://doi.org/10.34949/zywx-9253
CDISC StandardADS
Study ArmsBoth comparator and experimental arm data
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining more than one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill any remaining tumor cells. It was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.
ConditionsAdenocarcinoma of the Colon
Stage III Colon Cancer
Stage III Colon Cancer
Intervention TypeDrug: irinotecan hydrochloride
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Drug: Locally Directed Therapy
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab
Drug: Locally Directed Therapy
Drug(s)Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Drug: leucovorin calcium
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: Locally Directed Therapy
Total Enrolled3397
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionArm A (combination chemotherapy) - Experimental
Arm B (combination chemotherapy) - Experimental
Arm C (combination chemotherapy) - Experimental
Arm D (combination chemotherapy, monoclonal antibody) - Experimental
Arm E (combination chemotherapy, monoclonal antibody) - Experimental
Arm F (combination chemotherapy, monoclonal antibody) - Experimental
Arm G (Locally directed therapy) - Other
Arm B (combination chemotherapy) - Experimental
Arm C (combination chemotherapy) - Experimental
Arm D (combination chemotherapy, monoclonal antibody) - Experimental
Arm E (combination chemotherapy, monoclonal antibody) - Experimental
Arm F (combination chemotherapy, monoclonal antibody) - Experimental
Arm G (Locally directed therapy) - Other
Secondary IDN0147
PubMed (PMID)36306483
35963480
33863713
33356421
33203692
32165096
31811950
31268130
28983557
28006055
23623224
22474202
35963480
33863713
33356421
33203692
32165096
31811950
31268130
28983557
28006055
23623224
22474202
Collaborator(s)Eastern Cooperative Oncology Group
Region(s)United States
Canada
Puerto Rico
Canada
Puerto Rico
Age Range18 Years to 99 Years (Adult, Older Adult)
Files:
PROTOCOLn0147_protocol.pdf
CRFn0147_forms.pdf
DATA DICTIONARYn0147_ddt.pdf
DATA (BOTH COMPARATOR AND ACTIVE ARMS)characteristic.csv
DATA (BOTH COMPARATOR AND ACTIVE ARMS)tox.csv
DATA (BOTH COMPARATOR AND ACTIVE ARMS)objectives.csv