Resource-Sparing Curative Treatment for Rectal Cancer

Summary

This is a prospective, multicentre, randomized clinical trial comparing two different neo-adjuvant radiation-based strategies prior to intended surgery for locally advanced adenocarcinoma of the rectum.

This trial may establish the investigational therapy to be superior to, or at least not inferior to conventional treatment.

Conditions

• Rectal Carcinoma

Interventions

RADIATION

Radiotherapy

Short course radiotherapy: 25Gy in 5 daily fractions over 1 week Chemotherapy: - Bolus 5 Fluorouracil 450 mg/m2/day * Injected Leucovorin 20 mg/m2/day for 5 days

RADIATION

Radiotherapy

Conventional long course chemo-radiation: * Radiation 50Gy in 25 daily fractions over 5 weeks * Bolus 5 Fluorouracil 350mg/m2/d for 5 days * Injected Leucovorin 20mg in both the first and last (5th) week of radiation * Oral Capecitabine (CAPE) 825mg/m2 b.i.d. during the entire radiotherapy course over 5 weeks.

Sponsors & Collaborators

• Centre Anti Cancer Hopital Frantz Fanon

  collaborator UNKNOWN

• Hospital A.C. Camargo

  collaborator OTHER

• Credit Valley Hospital

  collaborator OTHER

• Instituto Nacional de Cancerologia, Columbia

  collaborator OTHER_GOV

• University Hospital Sestre Milosrdnice

  collaborator OTHER

• Minesterio de Cienca, Tecnologia y Medio Ambiente

  collaborator UNKNOWN

• V.N. Cancer Center GKNM Hospital

  collaborator UNKNOWN

• Tata Memorial Hospital

  collaborator OTHER_GOV

• Dr Cipto Mangunkusumo General Hospital

  collaborator OTHER

• National Cancer Center, Bratislava

  collaborator UNKNOWN

• University of Cape Town

  collaborator OTHER

• Catholic University of the Sacred Heart

  collaborator OTHER

• International Atomic Energy Agency

  lead OTHER_GOV

Principal Investigators

• Eduardo Rosenblatt · International Atomic Energy Agency

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-09-30

Primary Completion

2013-09-30

Countries

• Algeria
• Brazil
• Canada
• Colombia
• Croatia
• Cuba
• India
• Indonesia
• Italy
• Slovakia
• South Africa

Study Locations