Back to results

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

Primary Purpose

Pancreatic Cancer

Status

Active

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Induction chemotherapy with gemcitabine or FOLFIRINOX

Radiotherapy, 28 x 1.8 Gy

Chemotherapy, gemcitabine

Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, chemoradiotherapy, chemotherapy, FOLFIRINOX, gemcitabine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Induction CT, chemoradiotherapy

Induction CT, chemotherapy

Arm Description

Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;

Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Tumor-free survival

rate of local recurrence or local progression

Rate of distant metastasis

Acute and late toxicity of the chemoradiotherapy

Rate of remission

Rate of curative resections (R0) after chemotherapy and chemoradiotherapy

Changes in Quality of life

Full Information

NCT ID

NCT01827553

First Posted

April 4, 2013

Last Updated

August 28, 2023

Sponsor

University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT01827553

Brief Title

Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

April 4, 2013 (Actual)

Primary Completion Date

February 2, 2021 (Actual)

Study Completion Date

August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

pancreatic cancer, chemoradiotherapy, chemotherapy, FOLFIRINOX, gemcitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

830 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Induction CT, chemoradiotherapy

Arm Type

Experimental

Arm Description

Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;

Arm Title

Induction CT, chemotherapy

Arm Type

Active Comparator

Arm Description

Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

Intervention Type

Drug

Intervention Name(s)

Induction chemotherapy with gemcitabine or FOLFIRINOX

Other Intervention Name(s)

all brands of gemcitabine and FOLFIRINOX components are allowed

Intervention Description

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)

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy, 28 x 1.8 Gy

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Chemotherapy, gemcitabine

Other Intervention Name(s)

all brands of gemcitabine are allowed

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy

Other Intervention Name(s)

all brands of gemcitabine and FOLFIRINOX components are allowed

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall survival

Time Frame