Working… Menu

Resource-Sparing Curative Treatment for Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01459328
Recruitment Status : Unknown
Verified October 2011 by International Atomic Energy Agency.
Recruitment status was:  Recruiting
First Posted : October 25, 2011
Last Update Posted : October 25, 2011
Centre Anti Cancer Hopital Frantz Fanon
Hospital A.C. Camargo
Credit Valley Hospital
Instituto Nacional de Cancerologia, Columbia
University Hospital "Sestre Milosrdnice"
Minesterio de Cienca, Tecnologia y Medio Ambiente
V.N. Cancer Center GKNM Hospital
Tata Memorial Hospital
Dr Cipto Mangunkusumo General Hospital
National Cancer Center, Bratislava
University of Cape Town
Catholic University of the Sacred Heart
Information provided by (Responsible Party):
International Atomic Energy Agency

Brief 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.

Condition or disease Intervention/treatment Phase
Rectal Carcinoma Radiation: Radiotherapy Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Resource-Sparing Curative Treatment for Rectal Cancer
Study Start Date : September 2009
Estimated Primary Completion Date : September 2013

Arm Intervention/treatment
Active Comparator: Arm A: Conventional Long Course Chemo-Radiation
Conventional long course chemo-radiation
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

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

Secondary Outcome Measures :
  1. 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

  2. Quality of Life [ Time Frame: From date of randomization till the end of follow-up (5 years) ]
  3. 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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01459328

Layout table for location contacts
Contact: IAEA

Layout table for location information
Centre Anti-Cancer, Hopital Franz Fanon Recruiting
Blida, Algeria, 09000
Contact: Boualga Kada    +213 25 415985   
Principal Investigator: Boualga Kada         
Hospital A.C. Camargo, Fundacao Antonio Prudente Recruiting
Sao Paulo, Brazil, 01509-010
Contact: Maria Leticia Gobo Silva    +551132729613   
Principal Investigator: Maria Leticia Gobo Silva         
Canada, Ontario
Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Jidong Lian   
Principal Investigator: Jidong Lian         
Instituto Nacional de Cancerologia, Minesterio de Salud Recruiting
Bogota D.C., Colombia
Contact: Rosalba Ospinp Pena    005713341997   
Principal Investigator: Rosalba Ospino Pena         
Department of Oncology and Nuclear Medicine, University Hospital Sestre Milosrdnice Recruiting
Zagreb, Croatia, 10000
Contact: Ana Frobe    +38513787468   
Principal Investigator: Blanka Jaksic         
Ministerio de Cienca, Tecnologia y Medio Ambiente (CITMA) Recruiting
La Habana, Cuba
Contact: Maria Lourdes Pernez Pena    +5378316040   
Principal Investigator: Aixa Ulloa Balmaseda         
Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital Recruiting
Coimbatore, India, Tamil Nadu 641 037
Contact: Nagarajan Murugaiyan    +9104222216715   
Principal Investigator: Nagarajan Viswanathan         
Department of Radiation Oncology, Tata Memorial Hospital Recruiting
Mumbai, India, Maharashtra 400 012
Contact: Reena Engineer    +912224177163   
Contact    +912224177000      
Principal Investigator: Shyam Kishore Shrivastava         
Department of Radiotherapy, Dr. Cipto Mangunkusuma National General Hospital, University of Indonesia Recruiting
Jakarta, Indonesia, 10430
Contact: Sri Mutya Sekarutami    +62213921155   
Principal Investigator: Sri Mutya Sekarutami         
Instituto di Radiologia, Universita Cattolica del Sacro Cuore Recruiting
Roma, Italy, 00168
Contact: Vincenzo Valentini    +390630154376   
Principal Investigator: Vincenzo Valentini         
National Cancer Institute Recruiting
Bratislava, Slovakia, 833 10
Contact: Margita Pobijakova    +421259378579   
Principal Investigator: Margita Pobijakova         
South Africa
University of Cape Town Recruiting
Cape Town, South Africa, 7701
Contact: Barbara Robertson   
Principal Investigator: Barbara Robertson         
Sponsors and Collaborators
International Atomic Energy Agency
Centre Anti Cancer Hopital Frantz Fanon
Hospital A.C. Camargo
Credit Valley Hospital
Instituto Nacional de Cancerologia, Columbia
University Hospital "Sestre Milosrdnice"
Minesterio de Cienca, Tecnologia y Medio Ambiente
V.N. Cancer Center GKNM Hospital
Tata Memorial Hospital
Dr Cipto Mangunkusumo General Hospital
National Cancer Center, Bratislava
University of Cape Town
Catholic University of the Sacred Heart
Layout table for investigator information
Principal Investigator: Eduardo Rosenblatt International Atomic Energy Agency
Layout table for additonal information
Responsible Party: International Atomic Energy Agency Identifier: NCT01459328    
Other Study ID Numbers: E33034
First Posted: October 25, 2011    Key Record Dates
Last Update Posted: October 25, 2011
Last Verified: October 2011
Keywords provided by International Atomic Energy Agency:
rectal carcinoma
long course chemo-radiation
short course chemo-rdiation
Locally Advanced Rectal Carcinoma
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type