Resource-Sparing Curative Treatment for Rectal Cancer

October 24, 2011 updated by: International Atomic Energy Agency

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This phase III randomised clinical trial compares the outcome of two different neo-adjuvant radiation based treatments for locally advanced rectal carcinoma. This encompasses patients at risk for a positive circumfrential resection margin (CRM+) on baseline assessment imaging and pateints identified as being with a T-descriptor T4 at baseline assessment.

The arms compared are as follows:

  • The investigational arm: short chemo-radiation course(25Gy in 5 daily fractions over 1 week) +/- surgery.
  • The conventional arm: protracted chemo-radiation course (50Gy in 25 daily fractions over 5 weeks combined with chemotherapy)+/- surgery.

The outcomes include four domains: overall survival, biological effect, quality of life and health-related economics.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: IAEA

Study Locations

  • Algeria
      • Blida, Algeria, 09000
        • Recruiting
        • Centre Anti-Cancer, Hopital Franz Fanon
        • Contact:
        • Principal Investigator:
          • Boualga Kada
  • Brazil
      • Sao Paulo, Brazil, 01509-010
        • Recruiting
        • Hospital A.C. Camargo, Fundacao Antonio Prudente
        • Contact:
          • Maria Leticia Gobo Silva
          • Phone Number: +551132729613
          • Email: mlgobo@yahoo.fr
        • Principal Investigator:
          • Maria Leticia Gobo Silva
  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5M 2N1
        • Recruiting
        • Credit Valley Hospital
        • Contact:
        • Principal Investigator:
          • Jidong Lian
  • Colombia
      • Bogota D.C., Colombia
        • Recruiting
        • Instituto Nacional de Cancerologia, Minesterio de Salud
        • Contact:
        • Principal Investigator:
          • Rosalba Ospino Pena
  • Croatia
      • Zagreb, Croatia, 10000
        • Recruiting
        • Department of Oncology and Nuclear Medicine, University Hospital Sestre Milosrdnice
        • Contact:
        • Principal Investigator:
          • Blanka Jaksic
  • Cuba
      • La Habana, Cuba
        • Recruiting
        • Ministerio de Cienca, Tecnologia y Medio Ambiente (CITMA)
        • Contact:
        • Principal Investigator:
          • Aixa Ulloa Balmaseda
  • India
      • Coimbatore, India, Tamil Nadu 641 037
        • Recruiting
        • Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nagarajan Viswanathan
      • Mumbai, India, Maharashtra 400 012
        • Recruiting
        • Department of Radiation Oncology, Tata Memorial Hospital
        • Contact:
        • Contact:
          • Phone Number: +912224177000
        • Principal Investigator:
          • Shyam Kishore Shrivastava
  • Indonesia
      • Jakarta, Indonesia, 10430
        • Recruiting
        • Department of Radiotherapy, Dr. Cipto Mangunkusuma National General Hospital, University of Indonesia
        • Contact:
        • Principal Investigator:
          • Sri Mutya Sekarutami
  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Instituto di Radiologia, Universita Cattolica del Sacro Cuore
        • Contact:
  • Slovakia
      • Bratislava, Slovakia, 833 10
        • Recruiting
        • National Cancer Institute
        • Contact:
        • Principal Investigator:
          • Margita Pobijakova
  • South Africa
      • Cape Town, South Africa, 7701
        • Recruiting
        • University of Cape Town
        • Contact:
        • Principal Investigator:
          • Barbara Robertson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Clinical (i.e. surgical determination) and/or diagnostic image findings consistent with c/uT4 or CRM+ (note that CRM+ must be established by MRI), primary rectal Adenocarcinoma (i.e. histology consistent with origin from rectal mucosa); these constitute LARC for the purpose of this protocol
  • Treatment will be directed at the primary cancer, being clinically appropriate and given with an initial intent to cure the patient (this includes accepting up front that radiation and surgery are feasible; for surgery, this means that the patient has been determined fit for major surgery by an anaesthesiologist prior to the request for randomization)
  • Performance status is sufficient to undertake the treatment in either arm (KPS>50%)
  • Patient is accessible for required follow-up and data collection
  • Radiation oncologist expects survival to exceed 6 months from date of diagnosis
  • Patient provides informed consent

Exclusion Criteria:

  • Recurrent rectal cancer
  • Primary wholly in the sigmoid colon
  • Considered to be arising in the anal canal
  • Metastatic disease beyond the pelvis (by clinical assessment and/or diagnostic imaging)
  • Contraindications to protocol RT or to protocol chemotherapy, such as one or more of the following:
  • any prior RT to the pelvis; a solitary pelvic kidney within the intended radiation volume
  • consideration by the most responsible radiation oncologist that the treatment volume is too large, or the amount of small bowel or other critical organs within the treatment volume is too much for safe treatment
  • significantly abnormal laboratory tests such as impaired renal/liver function
  • a haemoglobin that is < 8.0 (or 80, SI) and the patient is not transfused to exceed 8.0 (or 80, SI)
  • on-going medications that are not compatible with protocol neo-adjuvant chemotherapy as described in this protocol
  • Significant development issues (such as with age < 18 yr)
  • Co-morbidity
  • Psychiatric diagnosis
  • Physical impairment
  • Pregnancy or continuing breast-feeding, that precludes administration of protocol treatments, or that precludes data collection (such as likely to preclude follow-up visits or completing questionnaires)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A: Conventional Long Course Chemo-Radiation
Conventional long course chemo-radiation
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.
Experimental: Arm B: Short Course Radiation Followed by Chemotherapy
Experimental short course radiation followed by chemotherapy.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: From commencement of radiation (day 1) to death or last follow-up up to 5 years.
From commencement of radiation (day 1) to death or last follow-up up to 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological Effect and Tumour Biology
Time Frame: Prior to surgical decision in weeks 13-15 and 4 weeks after surgery

Maximum size of the tumor based on imaging and/or up to 3D measures reported by radiologists, comparing baseline and pre-surgical decision inverstigations

If definitive surgery is conducted:

  • Proportion obtaining R0
  • Proportion undergoing TME
  • Status of the neurovascular and neural invasion(s)
  • Nodal ratio
  • Tumor sizes

CEA results
Prior to surgical decision in weeks 13-15 and 4 weeks after surgery
Quality of Life
Time Frame: From date of randomization till the end of follow-up (5 years)
From date of randomization till the end of follow-up (5 years)
Health-related Economics
Time Frame: From date of randomization till the end of follow-up (5 years)

Number of days in hospital

Number of surgical procedures

Number of days with stomas

Protocol required therapies, as actually administered

Adverse events that have significant cost implications (i.e. cost-drivers)
From date of randomization till the end of follow-up (5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International Atomic Energy Agency

Collaborators

Catholic University of the Sacred Heart
University of Cape Town
Tata Memorial Hospital
Dr Cipto Mangunkusumo General Hospital
University Hospital "Sestre Milosrdnice"
Instituto Nacional de Cancerologia, Columbia
Credit Valley Hospital
Hospital A.C. Camargo
Centre Anti Cancer Hopital Frantz Fanon
Minesterio de Cienca, Tecnologia y Medio Ambiente
V.N. Cancer Center GKNM Hospital
National Cancer Center, Bratislava

Investigators

  • Principal Investigator: Eduardo Rosenblatt, International Atomic Energy Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

October 10, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

October 25, 2011

Last Update Submitted That Met QC Criteria

October 24, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E33034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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