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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of Erlangen-Nürnberg Medical School
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01827553
First received: April 4, 2013
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Overall survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor-free survival [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • rate of local recurrence or local progression [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • Rate of distant metastasis [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • Acute and late toxicity of the chemoradiotherapy [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • Rate of remission [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]
  • Rate of curative resections (R0) after chemotherapy and chemoradiotherapy [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 830
Study Start Date: March 2013
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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)
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed
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
Other Name: all brands of gemcitabine are allowed
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 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)
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed
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
Other Name: all brands of gemcitabine and FOLFIRINOX components are allowed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827553

Contacts
Contact: Rainer Fietkau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de
Contact: Sabine Semrau, MD ++49(0)9131 85 ext 33968 st-studiensekretariat@uk-erlangen.de

  Show 50 Study Locations
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
Principal Investigator: Rainer Fietkau, MD Strahlenklinik, Universitätsklinikum Erlangen
  More Information

No publications provided

Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01827553     History of Changes
Other Study ID Numbers: 2009-014476-21
Study First Received: April 4, 2013
Last Updated: July 11, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
pancreatic cancer
chemoradiotherapy
chemotherapy
FOLFIRINOX
gemcitabine

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014