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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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
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.
Centre Anti-Cancer, Hopital Franz Fanon
Blida, Algeria
RECRUITINGHospital A.C. Camargo, Fundacao Antonio Prudente
São Paulo, Brazil
Overall Survival
Time frame: From commencement of radiation (day 1) to death or last follow-up up to 5 years.
Biological Effect and Tumour Biology
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
Time frame: 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)
Health-related Economics
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)
Time frame: From date of randomization till the end of follow-up (5 years)
IAEA
CONTACT
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Credit Valley Hospital
Mississauga, Ontario, Canada
RECRUITINGInstituto Nacional de Cancerologia, Minesterio de Salud
Bogota D.C., Colombia
RECRUITINGDepartment of Oncology and Nuclear Medicine, University Hospital Sestre Milosrdnice
Zagreb, Croatia
RECRUITINGMinisterio de Cienca, Tecnologia y Medio Ambiente (CITMA)
La Habana, Cuba
RECRUITINGDepartment of Radiation Oncology, V.N. Cancer Center, GKNM Hospital
Coimbatore, India
RECRUITINGDepartment of Radiation Oncology, Tata Memorial Hospital
Mumbai, India
RECRUITINGDepartment of Radiotherapy, Dr. Cipto Mangunkusuma National General Hospital, University of Indonesia
Jakarta, Indonesia
RECRUITINGInstituto di Radiologia, Universita Cattolica del Sacro Cuore
Roma, Italy
RECRUITING...and 2 more locations