Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)

University of Erlangen-Nürnberg Medical School

Status and phase: Completed; Phase 3

Conditions: Pancreatic Cancer

Treatments: Radiation: Radiotherapy, 28 x 1.8 Gy; Drug: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy; Drug: Chemotherapy, gemcitabine; Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX

Study type: Interventional

Funder types: Other

Identifiers

NCT01827553

2009-014476-21

Details and patient eligibility

About

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.

Enrollment: 830 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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830 participants in 2 patient groups

Induction CT, chemoradiotherapy

Experimental group

Description:

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

Treatment:

Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX

Radiation: Radiotherapy, 28 x 1.8 Gy

Drug: Chemotherapy, gemcitabine

Induction CT, chemotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Induction chemotherapy with gemcitabine or FOLFIRINOX

Drug: Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy