INTEnsification Radiotherapy with Accelerated fractionation or ChemoTherapy And Local Excision After 3D External Radio-chemotherapy - INTE.R.A.CT-LEADER TRIA

• Conditions: rectal cancer; MedDRA version: 6.1Level: PTClassification code 10038038

• Registration Number: EUCTR2005-005475-14-IT
• Lead Sponsor: POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-30
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 560

Inclusion Criteria

-Histologically confirmed primary adenocarcinoma of the rectum. - Tumour within 12 cm of the anal verge by proctoscopic examination or within 10 cm of the anorectal ring by MRI. - Clinical stages UICC 1997 cT3 N0-2. -Resectable disease at the routine examination. - Age 61619; 18 years. - Karnofsky Performance Status 61619;60. -WBC 61619; 4,000 cells/ml, platelets 61619; 100,000 cells/ml. written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Evidence of metastatic M1 disease. If there were any suspicious findings i.e. liver metastasis, lung nodule, retroperitoneal adenopathy, etc. the patient is to be considered as ineligible, unless malignancy is ruled out by tissue documentation biopsy before trial therapy is started. - Previous chemotherapy, immunotherapy, or radiation therapy to the pelvis. - Multiple primary cancers involving both the colon and rectum that would preclude a patient from being classified as having only rectal cancer. - Incomplete healing from or other surgery. -Active inflammatory bowel disease. - Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. - Cardiovascular disease with a New York Heart Association Functional Status 2. - Absolute neutrophil count ANC 4 x 109/L or platelets 100 x 109/L. - Mesured Creatinine clearance greater than 65ml/min. no drug dose reduction for lower GFR is allowed . - ALT or AST 2.5 times the ULRR -Pregnancy or breastfeeding women of child-bearing potential . - Any evidence of severe or uncontrolled systemic disease e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease . - Any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified