Status:
UNKNOWN
Preoperative Hyperfractionated Radiotherapy or Radiochemotherapy in Locally Advanced Rectal Cancer.
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Clinical objective of the study is to compare the rates of pathologic response, acute toxicity and sphincter preservation with two schedules of preoperative regiment in patients with locally advanced ...
Detailed Description
Overview of randomized trials conducted in patients with advanced colorectal cancer with the use of preoperative radiotherapy or radiochemotherapy clearly shows the superiority of combined therapy ove...
Eligibility Criteria
Inclusion
- Karnofsky Index 80% or better (Zubrod 0-1)
- Histological proved diagnosis of rectal cancer (adeno- or mucinous carcinoma)
- Primary rectal cancer:
- 1. Maximum 12 cm above dentate line (upper limit) 3.2. Staged T2N+ or T3N0 or T3N+ (by endorectal ultrasound or Computed Tomography \[CT\]/Magnetic Resonance Imaging \[MRI\] scan)
- No evidence of metastatic disease as determined by chest X-ray and abdominal ultrasound (or CT-scan of chest and abdomen or other investigations such as Positron Emission Tomography \[PET\] scan or biopsy if required)
- Adequate bone marrow function with platelets more than 100 × 10\^9/l and neutrophils more than 2.0 × 10\^9/l
- Creatinine clearance more than 50 ml/min
- Serum bilirubin less than 2.0 × Upper Limit of institutional Normal range (ULN)
- Written informed consent is obtained prior to commencement of trial treatment (confirmed the signature on the consent form for the proposed project and the standard medical consent form for radiotherapy within the abdominal cavity).
Exclusion
- Rectal cancer other than adeno- or mucinous carcinoma
- Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin
- Patients with locally advanced inoperable disease, such as T4-tumour
- Presence of metastatic disease or recurrent rectal tumour
- Any previous chemotherapy or radiotherapy, and any investigational treatment for rectal cancer
- Concurrent uncontrolled medical conditions
- Pregnancy or breast feeding
- Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease) or myocardial infarction within the last six months
- Evidence of hereditary colorectal cancer (Hereditary Non-Polyposis Colorectal Cancer \[HNPCC\] and Familial Adenomatous Polyposis \[FAP\])
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- No agreement for randomisation
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT01814969
Start Date
March 1 2014
End Date
December 1 2018
Last Update
May 5 2015
Active Locations (1)
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1
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch
Gliwice, Wybrzeze AK 15, Poland, 44-100