Skip to main content
OpenTrials
Completed

NCT Number: NCT01827553

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bayreuth, Klinikum, Bayreuth, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induction chemotherapy with gemcitabine or FOLFIRINOX

Drug

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 names: all brands of gemcitabine and FOLFIRINOX components are allowed

Radiotherapy, 28 x 1.8 Gy

Radiation

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.

Chemotherapy, gemcitabine

Drug

5 cycles of 300 mg/m^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m^2/d

Other names: all brands of gemcitabine are allowed

Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

Drug

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 names: all brands of gemcitabine and FOLFIRINOX components are allowed

Primary outcomes

  1. Overall survival

    Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Secondary outcomes

  1. Tumor-free survival

    Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  2. 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

  3. Rate of distant metastasis

    Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  4. 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

  5. Rate of remission

    Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

  6. 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

  7. Changes in Quality of life

    Time frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study 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

Acronym: CONKO-007

Important dates

Study start
2013
Primary completion
2021
Study completion
2023
First posted
Apr 9, 2013
Registry last updated
Apr 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.