Status:
UNKNOWN
IMRT-SIB and Capecitabine in Preoperative Rectal Cancer Treatment
Lead Sponsor:
Institute of Oncology Ljubljana
Conditions:
Rectal Carcinoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
RATIONALE: Using small radiation beamlets of different intensity, IMRT (intensity modulated radiation therapy) allows shaping the dose around planning target volume with better sparing of normal tissu...
Eligibility Criteria
Inclusion
- Biopsy-proven newly diagnosed primary rectal adenocarcinoma
- Locally advanced tumor fulfilling at least one of the following criteria on pelvic MRI:
- T ≥ 3 or
- N ≥ 1
- Positive mesorectal fascia (MRF), i.e. tumor or lymph node one mm or less from the mesorectal fascia
- Tumor located od 0 - 15 cm above anocutaneous junction or below peritoneum
- Age 18 years and more
- Signed informed consent
- WHO Performance Status 0-2
- Patients is considered to be mentally and physically ft for chemotherapy as judged by oncologist
- Adequate hematological, hepatic and renal function (WBC ≥ 3.0 x 109/L, neu ≥ 1.5 x 109/L, platelet count ≥ 100 x 109/L, renal clearance ≥ 50 ml/min, bilirubin ≤ 3x normal value, aspartate transaminase/alanine transaminase (AST/ALT) ≤ 2,5x normal value)
Exclusion
- T4 inoperable tumor - extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots
- Metastatic or recurrent rectal cancer
- Other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin
- Chronic bowel inflammatory disease
- Pregnant or lactating patient
- Significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmHg), New York Heart Association (NYHA) class III or IV heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment)
- Inability to consciously sign the consent form due to physical or psychological disabilities
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02268006
Start Date
January 1 2014
End Date
December 1 2020
Last Update
October 20 2014
Active Locations (1)
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1
Institute of Oncology
Ljubljana, Slovenia, 1000