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Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

NCT01827553 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 830

Last updated 2024-04-11

No results posted yet for this study

Summary

This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.

Conditions

Interventions

DRUG

Induction chemotherapy with gemcitabine or FOLFIRINOX

According to medical recommendation, induction chemotherapy is performed with gemcitabine (3 cycles a 3 administrations, 1000 mg/m\^2/d)or FOLFIRINOX (6 cycles; 1 cycle: oxaliplatin 85 mg/m\^2 2 h infusion, folinic acid 400 mg/ m\^2 2h infusion completed after 30 min with irinotecan infusion 180 mg/m\^2 for 90 minutes, bolus application 5-FU 400 mg/m\^2 followed by 46h infusion of 5-FU 2400 mg/m\^2)

RADIATION

Radiotherapy, 28 x 1.8 Gy

Radiotherapy combined with chemotherapy starts on day 1 of chemotherapy. Radiation volume is restricted to macroscopic visual tumor region. Radiation is performed in 28 fractions with 1.8 Gy resulting in a total dose of 50.4 Gy.

DRUG

Chemotherapy, gemcitabine

5 cycles of 300 mg/m\^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m\^2/d

DRUG

Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

Chemotherapeutic administration started with during induction chemotherapy is continued; Gemcitabine: 3 cycles a 3 administrations of 1000 mg/m\^2/d gemcitabine infusions FOLFIRINOX: 6 cycles

Sponsors & Collaborators

  • University of Erlangen-Nürnberg Medical School

    lead OTHER

Principal Investigators

  • Rainer Fietkau, MD · Strahlenklinik, Universitätsklinikum Erlangen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-04
Primary Completion
2021-02-02
Completion
2023-11-08

Countries

  • Germany

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827553 on ClinicalTrials.gov