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Radiochemotherapy in association with capecitabine and oxaliplatin in the treatment of pancreatic and biliary tract, unresectable cancer: a dose escalation study - XelOx -P07

Radiochemotherapy in association with capecitabine and oxaliplatin in the treatment of pancreatic and biliary tract, unresectable cancer: a dose escalation study - XelOx -P07

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004814-15-IT
Enrollment
Unknown
Registered
2007-10-24
Start date
2007-08-08
Completion date
Unknown
Last updated
2012-12-10

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

Conditions

pancreatic and biliary tract, unresectable cancer MedDRA version: 9.1 Level: LLT Classification code 10033611 Term: Pancreatic carcinoma non-resectable

Interventions

Trade Name: XELODA Pharmaceutical Form: Coated tablet INN or Proposed INN: Capecitabine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: ELOXATIN P

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Histologically proved carcinoma of pancreas or biliary tract measurable disease age >18 years performance status (ECOG) 0-1 no previous chemio or radiotherapeutic treatments 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: metastasis previous radiotherapy or chemiotherapy renal failure hepatic failure

Design outcomes

Primary

MeasureTime frame
Main Objective: To define the maximum tolerated dose (MTD) of Oxaliplatin in association to radiotherapy and capecitabine in the treatment of pancreatic and biliary tract, unresectable cancer;Secondary Objective: Evaluation of clinical response and resectability;Primary end point(s): To define the maximum tolerated dose (MTD) of Oxaliplatin in association to radiotherapy and capecitabine—

Countries

Italy

Outcome results

None listed

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