Phase II Clinical Trial ok weekly administration of oxaliplatin plus capecitabine and radioteraphy followed by surgery in patients with resectable locally advanced rectal cancer

Conditions: Pre-surgical Locally advanced rectal cancer treatment.

Registration Number: EUCTR2004-004475-12-ES

Lead Sponsor: Grupo de Tratamiento de los Tumores Digestivos

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Histologically confirmed rectal adenocarcinoma (< 15 cm from the anal verge)
2. Surgical locally advanced disease (T3 or T4 tumors) with or without regional lymph node involvement.
3. Radiologically measurable disease
4. No previous antineoplastic treatment
5. Age 18-75
6. ECOG 0 to 1.
7. No distant metastasis
8. No tumoral bleeding requiring blood trasfusion of 2 concentrates/week
9. Pre-treatment external derivation in occlusive tumors with important symptomatic disease
10. Life expectancy over 12 weeks
11. Adequate bone marrow function, determined by the following: Leucocytes >/ 4 x 109/l, Neutrophils >/ 1.5 x 109/l, Platelets >/ 100 x 109/l, Haemoglobin >/ 10 g/dl
12. Adequate liver function, determined by the following:Bilirubine < 1.25 upper normal limit (UNL), AST, ALT y alkaline phosphatase /< 2.5 UNL.
13. Adequate renal function, determined by the following: Serum creatinine /< 106 micromol/l or creatinine clearance over 50ml/min
14. Adequate nutritional status: wheight loss < 10% and albumin level > 35 g/L
15.- Written informed consent according to ICH-GCP
Are the trial subjects under 18?
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

1. Non-resectable rectal cancer: Sacral bone involvement. Bilateral ureteral involvement
2. Second neoplasy with the exception of adequately treated basal cell and spinocelular skin cancer, as well as cervical cancer.
3. Pregnancy or breast feeding
4. Absence of contraception
5. Medical history of miocardial infraction in the previous 6 months
6. Congestive heart disease or non-stable arrithmias despite of specific treatment.
7. Contraindication to surgery
8. Contraindication to oxaliplatin or capecitabine
9. Psicological, familiar or geographical problems that can interfere with the optimal follow-up and/or adherence to treatment scheme.
10. Syncronic colon neoplasia
11. Peripherial previous neuropathy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy, as of pathological response rate, of the combination of pre-surgical weekly oxaliplatin plus capecitabine and external radiotherapy in patients with advanced rectal cancer.;Secondary Objective: -R0 resection rate<br>-Surgical Complications rate-<br>To determine local and distant relapse rate<br>-Overall and disease-free survival;Primary end point(s): Pathological response rate

Secondary Outcome Measures