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PHASE II STUDY OF NEOADJUVANT CHEMORADIOTHERAPY IN LOCALLY ADVANCED RECTAL CANCER - XELOXART

PHASE II STUDY OF NEOADJUVANT CHEMORADIOTHERAPY IN LOCALLY ADVANCED RECTAL CANCER - XELOXART

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005661-11-IT
Enrollment
Unknown
Registered
2007-09-07
Start date
2006-03-30
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

rectal cancer MedDRA version: 6.1 Level: PT Classification code 10062099

Interventions

Trade Name: XELODA*120CPR RIV 500MG Pharmaceutical Form: Tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name:

Sponsors

AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Locally advanced rectal cancer (T3-4 and / or N+) 2) PS 0-1 WHO 3) 18-75 years age 4) 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

Exclusion criteria: 1) Controindications to surgery 2) Previous oncological therapies 3) Previous malignant tumors (a part skin cancer) 4) Rectal cancer responsible of severe stenosis or significant bleeding

Design outcomes

Primary

MeasureTime frame
Main Objective: efficacy evaluation in terms of pathological complete response to neoadjuvant capecitabine, oxaliplatinum and radiation in locally advanced rectal cancer;Secondary Objective: efficacy evaluation in terms of clinical response to neoadjuvant capecitabine, oxaliplatinum and radiation in locally advanced rectal cancer 2) evaluation of efficacy in terms of sphincter saving surgical procedures in distal rectal cancer 3) Disease free survival evaluation 4)Toxicity evaluation of neoadjuvant treatment 5) Pharmacogenomics and radiogenomics studies;Primary end point(s): pathological complete response to neoadjuvant chemoradiotherapy—

Countries

Italy

Outcome results

None listed

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