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Colorectal

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

Unique Data Set IDColorec_Allianc_2004_161
DownloadableYes
SponsorAlliance for Clinical Trials in Oncology Data ProviderAlliance for Clinical Trials in OncologyTotal Study Enrolled Patients3397Comparator (Control) Arm Enrolled Patients1337Experimental (Active) Arm Enrolled Patients1631RandomizationYesClinicalTrial.gov IDNCT00079274ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/study/NCT00079274?term=n0147&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataBoth comparator and experimental arm dataIntervention TypeDrug, ChemotherapyData Set TypeADS

Clinical Trial Title

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

Trial Summary and Conditions

This 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.

Data Summary

Control and experimental arms data files including data on demographics, end of treatment reason, histology, KRAS biomarker, disease free survival, time to recurrence, overall survival, toxicity, etc. (See data dictionary for more details).

Study Objectives

Primary 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.

Outcome Measures

The primary endpoint for this study was to compare the disease-free survival (DFS) in patients with stage III colon cancer who are KRAS wild-type randomized to one of two treatment regimens: 1) oxaliplatin, leucovorin calcium, and fluorouracil (Arm A) or 2) oxaliplatin, leucovorin calcium, fluorouracil and cetuximab (Arm D). Participants treated according to Arms B, C, E, and F treatment schedules received treatment which included irinotecan hydrochloride and therefore were not analyzed for this endpoint. Disease-free survival is defined as the time from randomization until tumor recurrence or death, whichever is first.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: n0147_protocol.pdf

CRF: n0147_forms.pdf

DATA DICTIONARY: n0147_ddt.pdf

OTHER: characteristic.csv

OTHER: tox.csv

OTHER: objectives.csv