Combination Chemotherapy After Surgery in Treating Patients With High-Risk Stage II or Stage III Colorectal Cancer

NCT00749450 | Completed Phase 3 DMC

• 6 other identifiers: CDR0000613042CRUK-SCOTISRCTN59757862EudraCT 2007-003957-10EU-20874SCOT-2007-01
• Study Type: interventional
• Target: 6,088
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, fluorouracil, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which combination chemotherapy regimen is more effective in treating patients who have undergone surgery for high-risk colorectal cancer. PURPOSE: This randomized phase III trial is studying chemotherapy given after surgery in treating patients with high-risk stage II or stage III colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage II colon cancer; stage III colon cancer; stage II rectal cancer; stage III rectal cancer

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3 years

Secondary Outcomes (4)

• Overall survival

  assessed during 5 year recruitment period and maximum 7 year follow up period

• Cost-effectiveness

  assessed during 5 year recruitment period

• Toxicity according to NCI CTCAE Version 3.0

  assessed during 5 year recruitment period

• Quality of life as assessed by EORTC QLQ-C30, EORTC QLQ-CR29, EQ-5D, and GOG Ntx4

  assessed during 5 year recruitment period

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive OxMdG or XELOX combination chemotherapy for a total of 12 courses for treatment lasting a total of 24 weeks.

Drug: capecitabine; Drug: fluorouracil; Drug: oxaliplatin

Arm II

EXPERIMENTAL

Patients receive OxMdG or XELOX combination chemotherapy for a total of 6 courses for treatment lasting a total of 12 weeks.

Drug: capecitabine; Drug: fluorouracil; Drug: oxaliplatin

Interventions

capecitabine DRUG

Given orally

Arm I; Arm II

fluorouracil DRUG

Given IV

Arm I; Arm II

oxaliplatin DRUG

Given IV

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Diagnosis of colorectal cancer meeting 1 of the following criteria: * High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, \< 10 nodes examined, poorly differentiated histology, extramural venous invasion, or extramural lymphatic invasion * Fully resected stage III disease * Patients with rectal cancer must meet the following criteria: * Underwent prior total mesorectal excision surgery with negative resection (R0) margins * No prior pre-operative or scheduled post-operative combined chemotherapy and radiotherapy * No evidence of residual or metastatic disease * Deemed suitable for adjuvant chemotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Life expectancy \> 5 years with reference to noncancer-related diseases * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9 g/dL * AST and ALT ≤ 2.5 times upper limit of normal * Carcinoembryonic antigen (CEA) levels normal * Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must effective contraception * More than 12 months since prior and no active clinically significant cardiovascular disease, including any of the following: * Cerebrovascular accident * Myocardial infarction * Unstable angina * New York Heart Association class II-IV congestive heart failure * Serious cardiac arrhythmia requiring medication * Uncontrolled hypertension (i.e., blood pressure \> 150/100 mm Hg) * Disease-free interval of ≥ 5 years for previous malignancy other than adequately treated in situ carcinoma of the uterine cervix or basal cell or squamous cell carcinoma of the skin * No known or suspected dihydropyrimidine dehydrogenase deficiency PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 10 weeks since prior surgery and recovered * No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant therapy) * No prior abdomino-pelvic radiotherapy, with the exception of short-course pre-operative radiotherapy for rectal cancer * No concurrent brivudine or sorivudine for patients taking capecitabine

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

Sponsors & Collaborators

• Cancer Research UK, Glasgow: lead

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Related Publications (2)

• 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: 36306483 DERIVED

• Iveson TJ, Sobrero AF, Yoshino T, Souglakos I, Ou FS, Meyers JP, Shi Q, Grothey A, Saunders MP, Labianca R, Yamanaka T, Boukovinas I, Hollander NH, Galli F, Yamazaki K, Georgoulias V, Kerr R, Oki E, Lonardi S, Harkin A, Rosati G, Paul J. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer. J Clin Oncol. 2021 Feb 20;39(6):631-641. doi: 10.1200/JCO.20.01330. Epub 2021 Jan 13.

  PMID: 33439695 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Capecitabine; Fluorouracil; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Study Officials

• Tim Iveson, FRCP, MD, MRCP, MBBS, BSC

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: September 6, 2008
• First Posted: September 9, 2008
• Study Start: March 1, 2008
• Primary Completion: November 1, 2017
• Last Updated: July 27, 2018

Record last verified: 2018-07

Locations

GB (1)