Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer

NCT00296608 | Completed Phase 3

• 3 other identifiers: CDR0000466625FFCD-9203EU-20600
• Study Type: interventional
• Target: 762
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective with or without chemotherapy when given before surgery for rectal cancer. PURPOSE: This randomized phase III trial is studying radiation therapy given together with fluorouracil and leucovorin to see how well they work compared to giving radiation therapy alone before surgery in treating patients with stage II or stage III rectal cancer.

Conditions

Colorectal Cancer

Keywords

stage II rectal cancer; stage III rectal cancer; adenocarcinoma of the rectum

Study Arms (2)

Radiotherapy

ACTIVE COMPARATOR

RT was delivered with photons from a linear accelerator with an energy level of 8MVor above.

Procedure: conventional surgery; Radiation: radiation therapy

Chemotherapy and radiotherapy

EXPERIMENTAL

The first CT cycle was administered from days 1 to 5 of the RT treatment. LV 20 mg/m2/d was delivered intravenously immediately before administration of FU. FU 350 mg/m2/d was delivered during 20 minutes in 100 mL of saline infusion, 1 hour before RT. The second cycle was administered from days 29 to 33 of the RT treatment using the same schedule.

Drug: fluorouracil; Drug: leucovorin calcium; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

fluorouracil DRUG

Chemotherapy and radiotherapy

leucovorin calcium DRUG

Chemotherapy and radiotherapy

conventional surgery PROCEDURE

Chemotherapy and radiotherapy; Radiotherapy

radiation therapy RADIATION

Chemotherapy and radiotherapy; Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the rectum meeting 1 of the following stage criteria: * Stage T3, N0-2, M0 disease meeting 1 of the following criteria: * Invasive disease in entire circumference (circular tumor) * Tumor fixed laterally or posteriorly to pelvic structures * Tumor adherent to the prostate and/or seminal vesicles * Tumor infiltration into the vaginal-rectal septum * Tumor classified as uT3 by rectal endoscopy * Stage T4, N0-2, M0 disease meeting 1 of the following criteria: * Clinical or radiologic evidence of pelvic organ extension (vagina, prostate, seminal vesicles, or bladder) * Tumor extension to the anal canal or sphincter * Tumor classified as uT4 by rectal endoscopy * Tumor accessible by digital rectal exam * Resectable disease * No distant metastases PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Creatinine \< 1.36 mg/dL * Granulocyte count \> 2,000/mm\^3 * Platelet count \> 130,000/mm\^3 * No progressive ischemic cardiomyopathy * No acute or chronic obstruction unless treated with diversion colostomy * No chronic inflammation of the ileum and/or colon * No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy, or surgery for this cancer

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

Sponsors & Collaborators

• Federation Francophone de Cancerologie Digestive: lead

Related Publications (6)

• Bonnetain F, Bosset JF, Gerard JP, Calais G, Conroy T, Mineur L, Bouche O, Maingon P, Chapet O, Radosevic-Jelic L, Methy N, Collette L. What is the clinical benefit of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question? Eur J Cancer. 2012 Aug;48(12):1781-90. doi: 10.1016/j.ejca.2012.03.016. Epub 2012 Apr 14.

  PMID: 22507892 BACKGROUND

• Bonnetain F, Bosset J, Gerard J, et al.: An analysis of preoperative chemoradiotherapy with 5FU/leucovorin for T3-4 rectal cancer on survival in a pooled analysis of EORTC 22921 and FFCD 9203 trials: surrogacy in question? [Abstract] J Clin Oncol 29 (Suppl 15): A-3506, 2011.

  BACKGROUND

• Methy N, Bedenne L, Conroy T, Bouche O, Chapet O, Ducreux M, Gerard JP, Bonnetain F. Surrogate end points for overall survival and local control in neoadjuvant rectal cancer trials: statistical evaluation based on the FFCD 9203 trial. Ann Oncol. 2010 Mar;21(3):518-524. doi: 10.1093/annonc/mdp340. Epub 2009 Sep 16.

  PMID: 19759186 RESULT

• Methy N, Bedenne L, Gerard J, et al.: Surrogate endpoints in neoadjuvant rectal cancer trials: statistical evaluation using data from the FFCD 9203 trial. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-466, 2008.

  RESULT

• Gerard JP, Conroy T, Bonnetain F, Bouche O, Chapet O, Closon-Dejardin MT, Untereiner M, Leduc B, Francois E, Maurel J, Seitz JF, Buecher B, Mackiewicz R, Ducreux M, Bedenne L. Preoperative radiotherapy with or without concurrent fluorouracil and leucovorin in T3-4 rectal cancers: results of FFCD 9203. J Clin Oncol. 2006 Oct 1;24(28):4620-5. doi: 10.1200/JCO.2006.06.7629.

  PMID: 17008704 RESULT

• Gerard J, Romestaing P, Bonnetain F, et al.: Preoperative chemotherapy (CT-RT) improves local control in T3-4 rectal cancers: results of the FFCD 9203 randomized trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-4, S2, 2005.

  RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Rectal Neoplasms

Interventions

Fluorouracil; Leucovorin; Radiotherapy

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)

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; Therapeutics

Study Officials

• Jean-Pierre Gerard, MD

  Centre Antoine Lacassagne

  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: February 24, 2006
• First Posted: February 27, 2006
• Study Start: April 1, 1993
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: May 30, 2016

Record last verified: 2016-05