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Resource-Sparing Curative Treatment for Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by International Atomic Energy Agency.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01459328
First received: October 10, 2011
Last updated: October 24, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Rectal Carcinoma
Radiation: Radiotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Resource-Sparing Curative Treatment for Rectal Cancer

Resource links provided by NLM:


Further study details as provided by International Atomic Energy Agency:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: From commencement of radiation (day 1) to death or last follow-up up to 5 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biological Effect and Tumour Biology [ Time Frame: Prior to surgical decision in weeks 13-15 and 4 weeks after surgery ] [ Designated as safety issue: No ]

    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


  • Quality of Life [ Time Frame: From date of randomization till the end of follow-up (5 years) ] [ Designated as safety issue: No ]
  • Health-related Economics [ Time Frame: From date of randomization till the end of follow-up (5 years) ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 350
Study Start Date: September 2009
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459328

Contacts
Contact: IAEA

Locations
Algeria
Centre Anti-Cancer, Hopital Franz Fanon Recruiting
Blida, Algeria, 09000
Contact: Boualga Kada    +213 25 415985    kboualga2002@yahoo.fr   
Principal Investigator: Boualga Kada         
Brazil
Hospital A.C. Camargo, Fundacao Antonio Prudente Recruiting
Sao Paulo, Brazil, 01509-010
Contact: Maria Leticia Gobo Silva    +551132729613    mlgobo@yahoo.fr   
Principal Investigator: Maria Leticia Gobo Silva         
Canada, Ontario
Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Jidong Lian       ombudsman@cvh.on.ca   
Principal Investigator: Jidong Lian         
Colombia
Instituto Nacional de Cancerologia, Minesterio de Salud Recruiting
Bogota D.C., Colombia
Contact: Rosalba Ospinp Pena    005713341997    rospino@cancer.gov.co   
Principal Investigator: Rosalba Ospino Pena         
Croatia
Department of Oncology and Nuclear Medicine, University Hospital Sestre Milosrdnice Recruiting
Zagreb, Croatia, 10000
Contact: Ana Frobe    +38513787468    afrobe@irb.hr   
Principal Investigator: Blanka Jaksic         
Cuba
Ministerio de Cienca, Tecnologia y Medio Ambiente (CITMA) Recruiting
La Habana, Cuba
Contact: Maria Lourdes Pernez Pena    +5378316040    soconcol@infomed.sld.cu   
Principal Investigator: Aixa Ulloa Balmaseda         
India
Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital Recruiting
Coimbatore, India, Tamil Nadu 641 037
Contact: Nagarajan Murugaiyan    +9104222216715    mnagarajan@gknmh.org   
Contact       mnr81@yahoo.com   
Principal Investigator: Nagarajan Viswanathan         
Department of Radiation Oncology, Tata Memorial Hospital Recruiting
Mumbai, India, Maharashtra 400 012
Contact: Reena Engineer    +912224177163    reena_engineer@rediffmail.com   
Contact    +912224177000      
Principal Investigator: Shyam Kishore Shrivastava         
Indonesia
Department of Radiotherapy, Dr. Cipto Mangunkusuma National General Hospital, University of Indonesia Recruiting
Jakarta, Indonesia, 10430
Contact: Sri Mutya Sekarutami    +62213921155    smutya12@yahoo.com   
Principal Investigator: Sri Mutya Sekarutami         
Italy
Instituto di Radiologia, Universita Cattolica del Sacro Cuore Recruiting
Roma, Italy, 00168
Contact: Vincenzo Valentini    +390630154376    vvalentini.it@email.it   
Principal Investigator: Vincenzo Valentini         
Slovakia
National Cancer Institute Recruiting
Bratislava, Slovakia, 833 10
Contact: Margita Pobijakova    +421259378579    margita.pobijakova@nou.sk   
Principal Investigator: Margita Pobijakova         
South Africa
University of Cape Town Recruiting
Cape Town, South Africa, 7701
Contact: Barbara Robertson       Barbara.robertson@uct.ac.za   
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
Investigators
Principal Investigator: Eduardo Rosenblatt International Atomic Energy Agency
  More Information

Publications:
Responsible Party: International Atomic Energy Agency
ClinicalTrials.gov Identifier: NCT01459328     History of Changes
Other Study ID Numbers: E33034
Study First Received: October 10, 2011
Last Updated: October 24, 2011
Health Authority: United Nations: International Atomic Energy Agency

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:
Carcinoma
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Rectal Diseases

ClinicalTrials.gov processed this record on November 25, 2014