Adjuvant Therapy(3 vs. 6 Months) With the FOLFOX 4 or XELOX for Stage II or Stage III Colon Cancer

NCT01308086 | Unknown Phase 3

• 1 other identifier: CT/09.12
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare whether a 3-month treatment is at least not inferior to a 6-month treatment (FOLFOX-4 6 vs. 12 cycles or XELOX 4 cycles vs. 8 cycles) in terms of RFS in patients with high risk stage II or stage III radically resected colon cancer.

Conditions

CRC

Keywords

Cancer; colorectal cancer; adjuvant chemotherapy; capecitabine; oxaliplatin; 5 fluorouracil

Outcome Measures

Primary Outcomes (1)

• Relapse Free Survival

  3-years

Secondary Outcomes (2)

• Overall Survival

  3-years

• Safety Profil according to NCI-CTAE v 3.0

  q2w

Study Arms (2)

FOLFOX 4 - 6months or XELOX -6months

ACTIVE COMPARATOR

Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Capecitabine

FOLFOX4 -3months or XELOX -3months

EXPERIMENTAL

Drug: 5-Fluorouracil; Drug: Leucovorin; Drug: Capecitabine; Drug: Oxaliplatin

Interventions

5-Fluorouracil DRUG

5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 \& 2, q2w, for 12 cycles

Also known as: 5-FU

FOLFOX 4 - 6months or XELOX -6months

Leucovorin DRUG

Leucovorin 200mg/m2 IV in 2 hours, days 1 \& 2, q2w, for 12 cycles

FOLFOX 4 - 6months or XELOX -6months

Oxaliplatin DRUG

Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles

Also known as: LoHP

FOLFOX 4 - 6months or XELOX -6months

Capecitabine DRUG

Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles

Also known as: Xeloda

FOLFOX 4 - 6months or XELOX -6months

Eligibility Criteria

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

You may qualify if:

• Histologically- - confirmed adenocarcinoma of the colon or rectum stage III or stage with at least one of the follow characteristics T4 tumours, undifferentiated tumor grade \>3, bowel obstruction or perforation, vascular or lymphatic or perineural invasion, \<12 nodes examined, Stage IV.
• Signed written informed consent
• Randomization between 2 -8 weeks after curative surgery
• Age \>18 years
• ECOG performance Status 0-1
• Pretreatment CEA within UNL
• Post-menopausal women or women willing to accept the use of an effective contraception. Pre-menopausal women should have a negative pregnancy test within 72 hours prior to randomization
• Men should also accept to use an effective contraception
• R0 resections

You may not qualify if:

• Evidence of metastatic disease (including presence of tumor cells in ascites or peritoneal carcinomatosis resected "en bloc")
• Evidence of other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
• No pregnant or lactating women
• Presence of clinically relevant cardiovascular disease
• Presenc of medical history or current evidence of CNS disease
• Presence of peripheral neuropathy ≤ grade 1 (CTCAE v. 3.0)
• History of clinically relevant psychiatric disability, precluding informed consent

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (1)

University Hospital of Crete, Dep of Medical Oncology

Heraklion, Greece

Location

Related Publications (3)

• 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

• Souglakos J, Boukovinas I, Kakolyris S, Xynogalos S, Ziras N, Athanasiadis A, Androulakis N, Christopoulou A, Vaslamatzis M, Ardavanis A, Emmanouilides C, Bompolaki I, Kourousis C, Makrantonakis P, Christofyllakis C, Athanasiadis E, Kentepozidis N, Karampeazis A, Katopodi U, Anagnosopoulos A, Papadopoulos G, Prinarakis E, Kalisperi A, Mavroudis D, Georgoulias V. Three- versus six-month adjuvant FOLFOX or CAPOX for high-risk stage II and stage III colon cancer patients: the efficacy results of Hellenic Oncology Research Group (HORG) participation to the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) project. Ann Oncol. 2019 Aug 1;30(8):1304-1310. doi: 10.1093/annonc/mdz193.

  PMID: 31228203 DERIVED

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• John Souglakos, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

• Vassilis Georgoulias, MD

  University Hospital of Crete, Dep of Medical Oncology

  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: March 1, 2011
• First Posted: March 3, 2011
• Study Start: October 1, 2010
• Primary Completion: November 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

GR (1)