NCT00265811

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer. PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,559

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Nov 2005

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2010

Completed
Last Updated

November 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4 years

First QC Date

December 14, 2005

Last Update Submit

November 5, 2020

Conditions

Colorectal Cancer

Keywords

stage III colon canceradenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    DFS time in the ITT KRAS wild-type population

    3-years DFS

Secondary Outcomes (1)

  • Overall survival

    5 years

Study Arms (2)

Folfox+Cetuximab

EXPERIMENTAL

FOLFOX-4 Cetuximab alone every 2 weeks

Drug: FolfoxDrug: Cetuximab

Folfox

ACTIVE COMPARATOR

FOLFOX-4 alone every 2 weeks

Drug: Folfox

Interventions

FolfoxDRUG
FolfoxFolfox+Cetuximab
CetuximabDRUG
Folfox+Cetuximab

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed stage III adenocarcinoma of the colon * Must have undergone curative resection (R0) within the past 28-56 days * No radiotherapy prior to surgery * carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery * No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery * No metastatic spread at baseline assessment * No prior or concurrent CNS disease by physical exam PATIENT CHARACTERISTICS: Performance status * WHO 0-1 Life expectancy * At least 5 years Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL Hepatic * Bilirubin ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 1.5 times ULN Renal * Creatinine ≤ 1.5 times ULN Cardiovascular * No coronary artery disease * No myocardial infarction within the past 12 months * No high risk of uncontrolled arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No inflammatory bowel disease * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No significant traumatic injury within the past 28 days * No known hypersensitivity to any of the components of the study drugs * No medical, geographical, sociological, psychological, or legal condition that would preclude study participation * No peripheral neuropathy ≥ grade 1 * No other significant disease that would preclude study participation PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Radiotherapy * See Disease Characteristics * No prior abdominal or pelvic irradiation Surgery * See Disease Characteristics * Recovered from prior surgery * More than 28 days since prior major surgical procedure or open biopsy * No concurrent major surgical procedure

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (8)

Hopital Duffaut

Avignon, 84902, France

Location

CHU de Caen

Caen, 14033, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Hopital Bichat - Claude Bernard

Paris, 75018, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Centre Hospitalier Yves Le Foll

Saint-Brieuc, BP 2367, France

Location

Nouvelle Clinique Generale

Valence, 26000, France

Location

Related Publications (6)

  • Taieb J, Puig PL, Bedenne L. Cetuximab plus FOLFOX-4 for fully resected stage III colon carcinoma: scientific background and the ongoing PETACC-8 trial. Expert Rev Anticancer Ther. 2008 Feb;8(2):183-9. doi: 10.1586/14737140.8.2.183.

    PMID: 18279058RESULT

  • Taieb J, Tabernero J, Mini E, Subtil F, Folprecht G, Van Laethem JL, Thaler J, Bridgewater J, Petersen LN, Blons H, Collette L, Van Cutsem E, Rougier P, Salazar R, Bedenne L, Emile JF, Laurent-Puig P, Lepage C; PETACC-8 Study Investigators. Oxaliplatin, fluorouracil, and leucovorin with or without cetuximab in patients with resected stage III colon cancer (PETACC-8): an open-label, randomised phase 3 trial. Lancet Oncol. 2014 Jul;15(8):862-73. doi: 10.1016/S1470-2045(14)70227-X. Epub 2014 Jun 11.

    PMID: 24928083RESULT

  • Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.

    PMID: 36306483DERIVED

  • Cohen R, Taieb J, Fiskum J, Yothers G, Goldberg R, Yoshino T, Alberts S, Allegra C, de Gramont A, Seitz JF, O'Connell M, Haller D, Wolmark N, Erlichman C, Zaniboni A, Lonardi S, Kerr R, Grothey A, Sinicrope FA, Andre T, Shi Q. Microsatellite Instability in Patients With Stage III Colon Cancer Receiving Fluoropyrimidine With or Without Oxaliplatin: An ACCENT Pooled Analysis of 12 Adjuvant Trials. J Clin Oncol. 2021 Feb 20;39(6):642-651. doi: 10.1200/JCO.20.01600. Epub 2020 Dec 23.

    PMID: 33356421DERIVED

  • Salem ME, Yin J, Goldberg RM, Pederson LD, Wolmark N, Alberts SR, Taieb J, Marshall JL, Lonardi S, Yoshino T, Kerr RS, Yothers G, Grothey A, Andre T, De Gramont A, Shi Q. Evaluation of the change of outcomes over a 10-year period in patients with stage III colon cancer: pooled analysis of 6501 patients treated with fluorouracil, leucovorin, and oxaliplatin in the ACCENT database. Ann Oncol. 2020 Apr;31(4):480-486. doi: 10.1016/j.annonc.2019.12.007. Epub 2020 Jan 16.

    PMID: 32085892DERIVED

  • Taieb J, Shi Q, Pederson L, Alberts S, Wolmark N, Van Cutsem E, de Gramont A, Kerr R, Grothey A, Lonardi S, Yoshino T, Yothers G, Sinicrope FA, Zaanan A, Andre T. Prognosis of microsatellite instability and/or mismatch repair deficiency stage III colon cancer patients after disease recurrence following adjuvant treatment: results of an ACCENT pooled analysis of seven studies. Ann Oncol. 2019 Sep 1;30(9):1466-1471. doi: 10.1093/annonc/mdz208.

    PMID: 31268130DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Interventions

Folfox protocolCetuximab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Julien Taieb, MD

    CHU Pitie-Salpetriere

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

November 1, 2005

Primary Completion

November 1, 2009

Study Completion

June 22, 2010

Last Updated

November 9, 2020

Record last verified: 2020-11

Locations

FR(8)