NCT01827553

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

Significance of Chemoradiation Following Induction Chemotherapy in Locally Advanced,Unresectable Pancreatic Cancer -a Randomised Phase 3 Trial: Chemoradiation Following Induction Chemotherapy Compared With Chemotherapy Alone

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 830 (estimated)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Pancreatic Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-04-04
• Primary completion: 2021-02-02
• Completion: 2023-11-08
• First posted: 2013-04-09
• Last updated: 2024-04-11

Locations

23 sites across 1 country: Germany