Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
NCT ID:
NCT01814969
Eligibility Criteria:
Inclusion Criteria:
1. Karnofsky Index 80% or better (Zubrod 0-1)
2. Histological proved diagnosis of rectal cancer (adeno- or mucinous carcinoma)
3. Primary rectal cancer:
3.1. 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)
4. 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)
5. Adequate bone marrow function with platelets more than 100 × 10\^9/l and neutrophils more than 2.0 × 10\^9/l
6. Creatinine clearance more than 50 ml/min
7. Serum bilirubin less than 2.0 × Upper Limit of institutional Normal range (ULN)
8. 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 Criteria:
1. Rectal cancer other than adeno- or mucinous carcinoma
2. Previous or concurrent malignancies, with the exception of adequately treated basal cell carcinoma of the skin
3. Patients with locally advanced inoperable disease, such as T4-tumour
4. Presence of metastatic disease or recurrent rectal tumour
5. Any previous chemotherapy or radiotherapy, and any investigational treatment for rectal cancer
6. Concurrent uncontrolled medical conditions
7. Pregnancy or breast feeding
8. Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease) or myocardial infarction within the last six months
9. Evidence of hereditary colorectal cancer (Hereditary Non-Polyposis Colorectal Cancer \[HNPCC\] and Familial Adenomatous Polyposis \[FAP\])
10. Medical or psychiatric conditions that compromise the patient's ability to give informed consent
11. No agreement for randomisation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01814969
Study Brief:
Protocol Section:
NCT01814969