Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

Phase 3

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX; Drug: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy; Radiation: Radiotherapy, 28 x 1.8 Gy; Drug: Chemotherapy, gemcitabine

• Registration Number: NCT01827553
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-04
• Study First Posted: 2013-04-09
• Primary Completion: 2021-02-02
• Status Verified: 2023-08
• Study Completion: 2023-11-08
• Last Update Submitted: 2024-04-10
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 830

Inclusion Criteria

• Age > 18 years
• histologically confirmed adenocarcinoma of the pancreas
• no evidence of distant metastasis based on computed tomography of the thorax and abdomen
• non resectable pancreatic cancer
• no evidence of peritoneal carcinosis
• ECOG-performance status ≤ 2
• signed study-specific consent form prior to therapy

Exclusion Criteria

• fertile patients who refuse effective contraception during study treatment
• synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in situ of the cervix after curative therapy
• the Inclusion of patients with prior or concurrent malignancy (≤ 5 years prior to enrolment in study) must be discussed
• chronic inflammatory disease of the intestine
• known allergic reactions on study medication
• on-treatment participation on other trials
• insufficient liver function: Bilirubin > 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal (after Stent implantation in case of obstructive jaundice); cirrhosis of the liver Child B and C
• insufficient bone marrow function: WBC < 3,0 x 10^9/l, Platelets > 100 x 10^9/l
• serum creatinine > 1,5 mg/dl, creatinin clearance < 60ml/min (or comparable test)
• preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease
• neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis
• active intractable or uncontrollable infection, HIV-infection
• prior radiotherapy or chemotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Induction CT, chemoradiotherapy	Induction chemotherapy with gemcitabine or FOLFIRINOX	Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
Induction CT, chemotherapy	Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy	Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Induction CT, chemotherapy	Induction chemotherapy with gemcitabine or FOLFIRINOX	Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Induction CT, chemoradiotherapy	Radiotherapy, 28 x 1.8 Gy	Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
Induction CT, chemoradiotherapy	Chemotherapy, gemcitabine	Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;

Primary Outcome Measures

Name	Time	Method
Overall survival	Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary Outcome Measures

Name	Time	Method
rate of local recurrence or local progression	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of curative resections (R0) after chemotherapy and chemoradiotherapy	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Tumor-free survival	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of remission	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Rate of distant metastasis	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Acute and late toxicity of the chemoradiotherapy	Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Changes in Quality of life	Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Trial Locations

Locations (23)

Göttingen Universitätsmedizin; 🇩🇪 Göttingen, Germany

Leipzig UCCL; 🇩🇪 Leipzig, Germany

Halle St. Elisabeth und St. Barbara Krankenhaus; 🇩🇪 Halle/Saale, Germany

Erlangen Universitätsklinikum; 🇩🇪 Erlangen, Germany

Jena Universitätsklinikum; 🇩🇪 Jena, Germany

Frankfurt/Main Universitätsklinikum; 🇩🇪 Frankfurt/Main, Germany

München Großhadern LMU; 🇩🇪 München, Germany

Bochum, St. Josef-Hospital; 🇩🇪 Bochum, Germany

Dresden Onkologische Gemeinschaftspraxis; 🇩🇪 Dresden, Germany

Freiburg Universitätsklinikum; 🇩🇪 Freiburg, Germany

Regensburg Krankenhaus Barmherzige Brüder; 🇩🇪 Regensburg, Germany

Regensburg Universitätsklinikum; 🇩🇪 Regensburg, Germany

Bayreuth, Klinikum; 🇩🇪 Bayreuth, Germany

Heilbronn SLK-Kliniken; 🇩🇪 Heilbronn, Germany

Magdeburg Klinikum; 🇩🇪 Magdeburg, Germany

Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie; 🇩🇪 Bochum, Germany

Leer MVM; 🇩🇪 Leer, Germany

Oldenburg Pius Hospital; 🇩🇪 Oldenburg, Germany

Köln Universitätsklinikum; 🇩🇪 Köln, Germany

Magdeburg Universitätsklinikum; 🇩🇪 Magdeburg, Germany

Mannheim Universitätsmedizin; 🇩🇪 Mannheim, Germany

Münster Universitätsklinikum; 🇩🇪 Münster, Germany

Würzburg CCC Mainfranken; 🇩🇪 Würzburg, Germany