Resource-Sparing Curative Treatment for Rectal Cancer
1 other identifier
interventional
350
11 countries
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 10, 2011
CompletedFirst Posted
Study publicly available on registry
October 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedOctober 25, 2011
October 1, 2011
4 years
October 10, 2011
October 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
From commencement of radiation (day 1) to death or last follow-up up to 5 years.
Secondary Outcomes (3)
Biological Effect and Tumour Biology
Prior to surgical decision in weeks 13-15 and 4 weeks after surgery
Quality of Life
From date of randomization till the end of follow-up (5 years)
Health-related Economics
From date of randomization till the end of follow-up (5 years)
Study Arms (2)
Arm A: Conventional Long Course Chemo-Radiation
ACTIVE COMPARATORConventional long course chemo-radiation
Arm B: Short Course Radiation Followed by Chemotherapy
EXPERIMENTALExperimental short course radiation followed by chemotherapy.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- International Atomic Energy Agencylead
- Centre Anti Cancer Hopital Frantz Fanoncollaborator
- Hospital A.C. Camargocollaborator
- Credit Valley Hospitalcollaborator
- Instituto Nacional de Cancerologia, Columbiacollaborator
- University Hospital Sestre Milosrdnicecollaborator
- Minesterio de Cienca, Tecnologia y Medio Ambientecollaborator
- V.N. Cancer Center GKNM Hospitalcollaborator
- Tata Memorial Hospitalcollaborator
- Dr Cipto Mangunkusumo General Hospitalcollaborator
- National Cancer Center, Bratislavacollaborator
- University of Cape Towncollaborator
- Catholic University of the Sacred Heartcollaborator
Study Sites (12)
Centre Anti-Cancer, Hopital Franz Fanon
Blida, 09000, Algeria
Hospital A.C. Camargo, Fundacao Antonio Prudente
São Paulo, 01509-010, Brazil
Credit Valley Hospital
Mississauga, Ontario, L5M 2N1, Canada
Instituto Nacional de Cancerologia, Minesterio de Salud
Bogota D.C., Colombia
Department of Oncology and Nuclear Medicine, University Hospital Sestre Milosrdnice
Zagreb, 10000, Croatia
Ministerio de Cienca, Tecnologia y Medio Ambiente (CITMA)
La Habana, Cuba
Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital
Coimbatore, Tamil Nadu 641 037, India
Department of Radiation Oncology, Tata Memorial Hospital
Mumbai, Maharashtra 400 012, India
Department of Radiotherapy, Dr. Cipto Mangunkusuma National General Hospital, University of Indonesia
Jakarta, 10430, Indonesia
Instituto di Radiologia, Universita Cattolica del Sacro Cuore
Roma, 00168, Italy
National Cancer Institute
Bratislava, 833 10, Slovakia
University of Cape Town
Cape Town, 7701, South Africa
Related Publications (4)
Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. doi: 10.1056/NEJMoa060829.
PMID: 16971718BACKGROUNDKapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ; Dutch Colorectal Cancer Group. Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer. N Engl J Med. 2001 Aug 30;345(9):638-46. doi: 10.1056/NEJMoa010580.
PMID: 11547717BACKGROUNDRadu C, Berglund A, Pahlman L, Glimelius B. Short-course preoperative radiotherapy with delayed surgery in rectal cancer - a retrospective study. Radiother Oncol. 2008 Jun;87(3):343-9. doi: 10.1016/j.radonc.2007.11.025. Epub 2008 Feb 21.
PMID: 18093674BACKGROUNDBraendengen M, Tveit KM, Berglund A, Birkemeyer E, Frykholm G, Pahlman L, Wiig JN, Bystrom P, Bujko K, Glimelius B. Randomized phase III study comparing preoperative radiotherapy with chemoradiotherapy in nonresectable rectal cancer. J Clin Oncol. 2008 Aug 1;26(22):3687-94. doi: 10.1200/JCO.2007.15.3858.
PMID: 18669453BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eduardo Rosenblatt
International Atomic Energy Agency
Central Study Contacts
IAEA
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2011
First Posted
October 25, 2011
Study Start
September 1, 2009
Primary Completion
September 1, 2013
Last Updated
October 25, 2011
Record last verified: 2011-10