Feasibility of radiotherapy and concomitant gemcitabine and oxaliplatin in locally advanced pancreatic cancer and distal cholangiocarcinoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001126-24-BE

Enrollment

Registered

2005-12-20

Start date

2004-10-25

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

Pancreatic cancer or distal cholangiocarcinoma

Interventions

Trade Name: Gemzar Product Name: Gemzar Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Gemcitabine hydrochloride CAS Number: 122111-03-9 Concentration unit: mg/g milligram(s)/gram Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * Histological proven and unresectable adenocarcinoma of the pancreas or cholangiocarcinoma with no evidence of metastatic disease. * WHO performance status 0-1 * Adequate bone marrow reserve. * No previous chemotherapy or radiotherapy. 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * Previous or co-existent malignant disease except non melanoma skin cancers and adequately treated cervix carcinoma in situ. * Active infection. * Metastatic disease. * Inadequate renal or liver function. * Pregnancy. * Use of any other investigational agent in the month before enrolment into the study. * Age < 18 years.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose deliverd, of an assocation of gemcitabine, oxalitplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma.;Secondary Objective: Respectability rate and overall survival.;Primary end point(s): Feasibility and tolerance.	—

Measure

Time frame

Main Objective: To evaluate the feasibility defined as overall tolerance and toxicity as well as relative dose-intensity and cumulative dose deliverd, of an assocation of gemcitabine, oxalitplatin and radiotherapy in patients with locally advanced and unresectable, but non-metastatic pancreatic adenocarcinoma or cholangiocarcinoma.;Secondary Objective: Respectability rate and overall survival.;Primary end point(s): Feasibility and tolerance.

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Countries

Belgium

Outcome results

None listed

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