Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

Study Overview

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.

N/A

Pancreatic Cancer

DRUG: Induction chemotherapy with gemcitabine or FOLFIRINOX
RADIATION: Radiotherapy, 28 x 1.8 Gy
DRUG: Chemotherapy, gemcitabine
DRUG: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

2009-014476-21

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2013-04-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-10
First Submitted that Met QC Criteria 2013-04-04	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-11
First Posted (ACTUAL) 2013-04-09	Results First Posted N/A	Last Verified 2023-08

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Factorial

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Induction CT, chemoradiotherapy Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;	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 aft 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
ACTIVE_COMPARATOR: Induction CT, chemotherapy Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy	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 aft 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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Induction CT, chemoradiotherapy

Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;

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 aft

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

ACTIVE_COMPARATOR: Induction CT, chemotherapy

Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

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 aft

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

Primary Outcome Measures	Measure Description	Time Frame
Overall survival		Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary Outcome Measures	Measure Description	Time Frame
Tumor-free survival		Participants will be followed for the duration of therapy and for 5 years after the last study treatment
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 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
Rate of remission		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
Changes in Quality of life		Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Rainer Fietkau, MD, Strahlenklinik, Universitätsklinikum Erlangen

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Wittel UA, Lubgan D, Ghadimi M, Belyaev O, Uhl W, Bechstein WO, Grutzmann R, Hohenberger WM, Schmid A, Jacobasch L, Croner RS, Reinacher-Schick A, Hopt UT, Pirkl A, Oettle H, Fietkau R, Golcher H. Consensus in determining the resectability of locally progressed pancreatic ductal adenocarcinoma - results of the Conko-007 multicenter trial. BMC Cancer. 2019 Oct 22;19(1):979. doi: 10.1186/s12885-019-6148-5.

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