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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-004475-12-ES
Enrollment
Unknown
Registered
2006-04-26
Start date
2005-04-21
Completion date
Unknown
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-surgical Locally advanced rectal cancer treatment.

Interventions

Trade Name: Xeloda®500mg Product Name: CAPECITABINE Pharmaceutical Form: Tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50

Sponsors

Grupo de Tratamiento de los Tumores Digestivos
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed rectal adenocarcinoma (/ 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 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

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

Design outcomes

Primary

MeasureTime frame
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 -Surgical Complications rate- To determine local and distant relapse rate -Overall and disease-free survival;Primary end point(s): Pathological response rate—

Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026