Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
350 participants
INTERVENTIONAL
2009-09-30
Brief Summary
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This trial may establish the investigational therapy to be superior to, or at least not inferior to conventional treatment.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Conventional Long Course Chemo-Radiation
Conventional long course chemo-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.
Arm B: Short Course Radiation Followed by Chemotherapy
Experimental short course radiation followed by chemotherapy.
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
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Centre Anti Cancer Hopital Frantz Fanon
UNKNOWN
Hospital A.C. Camargo
OTHER
Credit Valley Hospital
OTHER
Instituto Nacional de Cancerologia, Columbia
OTHER_GOV
University Hospital Sestre Milosrdnice
OTHER
Minesterio de Cienca, Tecnologia y Medio Ambiente
UNKNOWN
V.N. Cancer Center GKNM Hospital
UNKNOWN
Tata Memorial Hospital
OTHER_GOV
Dr Cipto Mangunkusumo General Hospital
OTHER
National Cancer Center, Bratislava
UNKNOWN
University of Cape Town
OTHER
Catholic University of the Sacred Heart
OTHER
International Atomic Energy Agency
OTHER_GOV
Responsible Party
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Principal Investigators
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Eduardo Rosenblatt
Role: PRINCIPAL_INVESTIGATOR
International Atomic Energy Agency
Locations
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Centre Anti-Cancer, Hopital Franz Fanon
Blida, , Algeria
Hospital A.C. Camargo, Fundacao Antonio Prudente
São Paulo, , Brazil
Credit Valley Hospital
Mississauga, Ontario, Canada
Instituto Nacional de Cancerologia, Minesterio de Salud
Bogota D.C., , Colombia
Department of Oncology and Nuclear Medicine, University Hospital Sestre Milosrdnice
Zagreb, , Croatia
Ministerio de Cienca, Tecnologia y Medio Ambiente (CITMA)
La Habana, , Cuba
Department of Radiation Oncology, V.N. Cancer Center, GKNM Hospital
Coimbatore, , India
Department of Radiation Oncology, Tata Memorial Hospital
Mumbai, , India
Department of Radiotherapy, Dr. Cipto Mangunkusuma National General Hospital, University of Indonesia
Jakarta, , Indonesia
Instituto di Radiologia, Universita Cattolica del Sacro Cuore
Roma, , Italy
National Cancer Institute
Bratislava, , Slovakia
University of Cape Town
Cape Town, , South Africa
Countries
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Central Contacts
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IAEA
Role: CONTACT
Facility Contacts
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Role: backup
Role: backup
References
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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.
Kapiteijn 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.
Radu 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.
Braendengen 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.
Other Identifiers
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E33034
Identifier Type: -
Identifier Source: org_study_id