Clinical trial NCT01827553: Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
chemoradiotherapy
chemotherapy
FOLFIRINOX
gemcitabine
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2013-04-09
Enrollment: 830
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Secondary outcomes:
measure: Tumor-free survival
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: rate of local recurrence or local progression
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: Rate of distant metastasis
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: Acute and late toxicity of the chemoradiotherapy
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: Rate of remission
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: Rate of curative resections (R0) after chemotherapy and chemoradiotherapy
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
measure: Changes in Quality of life
timeFrame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment
Other outcomes:
Locations:
city: Bayreuth
country: Germany
facility: Bayreuth, Klinikum
city: Bochum
country: Germany
facility: Bochum, Augusta-Kranken-Anstalt, Hämatologie/Onkologie
city: Bochum
country: Germany
facility: Bochum, St. Josef-Hospital
city: Dresden
country: Germany
facility: Dresden Onkologische Gemeinschaftspraxis
city: Erlangen
country: Germany
facility: Erlangen Universitätsklinikum
city: Frankfurt/Main
country: Germany
facility: Frankfurt/Main Universitätsklinikum
city: Freiburg
country: Germany
facility: Freiburg Universitätsklinikum
city: Göttingen
country: Germany
facility: Göttingen Universitätsmedizin
city: Halle/Saale
country: Germany
facility: Halle St. Elisabeth und St. Barbara Krankenhaus
city: Heilbronn
country: Germany
facility: Heilbronn SLK-Kliniken
city: Jena
country: Germany
facility: Jena Universitätsklinikum
city: Köln
country: Germany
facility: Köln Universitätsklinikum
city: Leer
country: Germany
facility: Leer MVM
city: Leipzig
country: Germany
facility: Leipzig UCCL
city: Magdeburg
country: Germany
facility: Magdeburg Universitätsklinikum
city: Magdeburg
country: Germany
facility: Magdeburg Klinikum
city: Mannheim
country: Germany
facility: Mannheim Universitätsmedizin
city: München
country: Germany
facility: München Großhadern LMU
city: Münster
country: Germany
facility: Münster Universitätsklinikum
city: Oldenburg
country: Germany
facility: Oldenburg Pius Hospital
city: Regensburg
country: Germany
facility: Regensburg Krankenhaus Barmherzige Brüder
city: Regensburg
country: Germany
facility: Regensburg Universitätsklinikum
city: Würzburg
country: Germany
facility: Würzburg CCC Mainfranken
Study officials:
affiliation: Strahlenklinik, Universitätsklinikum Erlangen
name: Rainer Fietkau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.