Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

Pancreatic Cancer Clinical Trial

— CONKO-007  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01827553
• Other study ID #: 2009-014476-21
• Status: Completed
• Phase: Phase 3
• Start date: April 4, 2013
• Est. completion date: November 8, 2023

Study information

• Verified date: August 2023
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 830
• Est. completion date: November 8, 2023
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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
• 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

Locations

Country	Name	City	State
Germany	Bayreuth, Klinikum	Bayreuth
Germany	Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie	Bochum
Germany	Bochum, St. Josef-Hospital	Bochum
Germany	Dresden Onkologische Gemeinschaftspraxis	Dresden
Germany	Erlangen Universitätsklinikum	Erlangen
Germany	Frankfurt/Main Universitätsklinikum	Frankfurt/Main
Germany	Freiburg Universitätsklinikum	Freiburg
Germany	Göttingen Universitätsmedizin	Göttingen
Germany	Halle St. Elisabeth und St. Barbara Krankenhaus	Halle/Saale
Germany	Heilbronn SLK-Kliniken	Heilbronn
Germany	Jena Universitätsklinikum	Jena
Germany	Köln Universitätsklinikum	Köln
Germany	Leer MVM	Leer
Germany	Leipzig UCCL	Leipzig
Germany	Magdeburg Klinikum	Magdeburg
Germany	Magdeburg Universitätsklinikum	Magdeburg
Germany	Mannheim Universitätsmedizin	Mannheim
Germany	München Großhadern LMU	München
Germany	Münster Universitätsklinikum	Münster
Germany	Oldenburg Pius Hospital	Oldenburg
Germany	Regensburg Krankenhaus Barmherzige Brüder	Regensburg
Germany	Regensburg Universitätsklinikum	Regensburg
Germany	Würzburg CCC Mainfranken	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary	Tumor-free survival		Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary	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
Secondary	Rate of distant metastasis		Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary	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
Secondary	Rate of remission		Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary	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
Secondary	Changes in Quality of life		Participants will be followed for the duration of therapy and for 5 years after the last study treatment