Trial Testing Ftorafur (UFT) Associated With Neoadjuvant Radiotherapy Versus Radiotherapy Alone in Rectal Adenocarcinoma

NCT00207831 | Terminated Phase 3 DMC

• 1 other identifier: CPP276
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 27

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as 5-fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing and also as a radiosensibilisant. Radiation therapy uses high-energy x-rays to kill tumor cells. 5-fluorouracil may make tumor cells more sensitive to radiation therapy. Oral 5-fluorouracil is more convenient for ambulatory patients. Giving UFT (Tegafur and Uracil) with radiation therapy before surgery may shrink the tumor so it can be removed. PURPOSE: This phase III trial is studying how well giving UFT with radiation therapy works in treating patients who are undergoing surgery for operable rectal cancer.

Conditions

Rectal Cancer; Stage II/III; T3 or T4 (Only Anal Extension) Rectal Cancer; N0-2; M0

Keywords

rectal cancer; neoadjuvant therapy; UFT; radiochemotherapy

Outcome Measures

Primary Outcomes (1)

• Compare the rate of pathologic complete response of the primary tumor in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone

Secondary Outcomes (7)

• Compare endoscopic ultrasonographic response in patients with operable rectal cancer receiving preoperative chemoradiotherapy versus patients receiving radiotherapy alone.

• Compare quality of life (Quality of Life Questionnaire Core 30 Items [QLQ-C 30])

• Compare the rate of sphincter conservation alone.

• Compare the safety of the chemoradiotherapy regimen to radiotherapy alone

• Compare the rate of resectability with negative resection margins in patients treated with this two regimen.

Study Arms (2)

Tegafur uracile + radiotherapy

EXPERIMENTAL

Drug: Tegafur and Uracil

radiotherapy

ACTIVE COMPARATOR

Drug: Tegafur and Uracil

Interventions

Tegafur and Uracil DRUG

Tegafur uracile + radiotherapy; radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the rectum , M0, lower side \< 10 cm from anal verge * T3 or T4 disease (T4 exclusive anal extension ) PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 OR * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< x2 UNL Renal * Creatinine \< 150 µMol/L Gastrointestinal * No history of inflammatory bowel disease * No history of difficulty or inability to take or absorb oral medications Neurologic * Not specified Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix * No history of psychiatric conditions or diminished mental capacity that would preclude study compliance or giving informed consent PRIOR CONCURRENT THERAPY: Chemotherapy * No prior chemotherapy Radiotherapy * No prior radiotherapy to the pelvis Other * No other concurrent investigational drugs * No other concurrent anticancer treatment

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

Sponsors & Collaborators

• Institut Cancerologie de l'Ouest: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (27)

Clinique Sainte Catherine

Avignon, 84000, France

Location

Hopital Avicenne

Bobigny, 93, France

Location

Institut de Cancérologie et d'Hématologie

Brest, 29609, France

Location

Centre Hospitalier

Brive-la-Gaillarde, 19312, France

Location

Centre d'Oncologie-radiothérapie d'Eure et Loir

Chartres, 28006, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Centre Médical République

Clermont-Ferrand, 63023, France

Location

Clinique du Mail

Grenoble, 38100, France

Location

Centre Hospitalier Départemental

La Roche-sur-Yon, 85025, France

Location

Centre Guillaume le Conquérant

Le Havre, 76600, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospitalier

Lorient, 56322, France

Location

Centre léon Bérard

Lyon, 69373, France

Location

Centre Gray

Maubeuge, 59600, France

Location

Clinique du Pont de Chaume

Montauban, 82017, France

Location

Polyclinique St Roch

Montpellier, 34967, France

Location

Centre Hospitalier

Niort, 79021, France

Location

Clinique Valdegour

Nîmes, 30900, France

Location

Centre Hospitalier Universitaire

Poitiers, 86021, France

Location

Centre Hospitalier de Cornouaille

Quimper, 29000, France

Location

Centre Eugène Marquis

Rennes, 35042, France

Location

Centre Hospitalier

Rodez, 12027, France

Location

Centre Frédéric Joliot

Rouen, 76000, France

Location

Clinique Armoricaine de Radiologie

Saint-Brieuc, 22015, France

Location

Centre de Radiothérapie

Strasbourg, 67000, France

Location

Centre des Hautes Energies

Toulouse, 31400, France

Location

Clinique Fleming

Tours, 37000, France

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Tegafur; Uracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluorouracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Patrice Cellier, MD

  Institut Cancerologie de l'Ouest

  STUDY CHAIR

• Rémy Barraya, MD

  Institut Cancerologie de l'Ouest

  STUDY CHAIR

• Christian Chevelle, MD

  Centre des Hautes Energie, Toulouse

  STUDY CHAIR

• Gérard Lorimier, MD

  Institut Cancerologie de l'Ouest

  STUDY CHAIR

• Véronique Verrièle, MD

  Institut Cancerologie de l'Ouest

  STUDY CHAIR

• Michèle Boisdron, Pct, PhD

  Institut Cancerologie de l'Ouest

  STUDY CHAIR

• Loïc Campion, MD

  Centre René Gauducheau, Nantes

  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: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: February 1, 2008
• Last Updated: March 25, 2020

Record last verified: 2020-03

Locations

FR (27)