Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

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.

Timeline

Start

2013-04-04

Primary completion

2021-02-02

Completion

2023-11-08

Outcome

Missed primary endpoint

paper The primary end point (overall R0 resection rate) was not significantly different between treatment arms PMID 40802908 ↗

paper 18% in the chemotherapy arm (30 of 167; P = .113). PMID 40802908 ↗

Publications

• Fietkau R, Ghadimi M, Grutzmann R, Wittel UA, Jacobasch L, Uhl W, Croner RS, Bechstein WO, Neumann UP, Waldschmidt D, Boeck S, Moosmann N, Reinacher-Schick AC, Golcher H, Adler W, Semrau S, Lubgan D, Kallies A, Hecht M, Tischoff I, Tannapfel A, Frey B, Oettle H; CONKO Study Group. Benefit of Chemoradiotherapy Versus Chemotherapy After Induction Therapy for Conversion of Unresectable Into Resectable Pancreatic Cancer: The Randomized CONKO-007 Trial. J Clin Oncol. 2025 Oct 20;43(30):3266-3278. doi: 10.1200/JCO-24-01502. Epub 2025 Aug 13.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	300 mg/m2	Other
Subject	Gemcitabine	Small molecule	1000 mg/m2	Other
Subject	Irinotecan	Small molecule	180 mg/m2	Other
Subject	Leucovorin	Small molecule	400 mg/m2	Other
Subject	Oxaliplatin	Small molecule	85 mg/m2	Other
Subject	fluorouracil	Small molecule	400 mg/m2	Other
Subject	fluorouracil	Small molecule	2400 mg/m2	Other

Indications