Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy (CONKO-007)
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| ClinicalTrials.gov Identifier: NCT01827553 |
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Recruitment Status :
Active, not recruiting
First Posted : April 9, 2013
Last Update Posted : May 7, 2021
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Sponsor:
University of Erlangen-Nürnberg Medical School
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
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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.
| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Estimated Enrollment : | 830 participants |
| Allocation: | Randomized |
| Intervention Model: | Factorial Assignment |
| Masking: | None (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 |
| Study Start Date : | March 2013 |
| Estimated Primary Completion Date : | April 2022 |
| Estimated Study Completion Date : | April 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pancreatic Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Induction CT, chemoradiotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Radiotherapy, 28 x 1.8 Gy; Chemotherapy, gemcitabine;
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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 |
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Active Comparator: Induction CT, chemotherapy
Induction chemotherapy with gemcitabine or FOLFIRINOX; Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
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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 |
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 ]
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 ]
- 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 ]
- Rate of distant metastasis [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
- 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 ]
- Rate of remission [ Time Frame: Participants will be followed for the duration of therapy and for 5 years after the last study treatment ]
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01827553
Locations
Show 49 study locations
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
| Principal Investigator: | Rainer Fietkau, MD | Strahlenklinik, Universitätsklinikum Erlangen |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Erlangen-Nürnberg Medical School |
| ClinicalTrials.gov Identifier: | NCT01827553 |
| Other Study ID Numbers: |
2009-014476-21 |
| First Posted: | April 9, 2013 Key Record Dates |
| Last Update Posted: | May 7, 2021 |
| Last Verified: | January 2021 |
Keywords provided by University of Erlangen-Nürnberg Medical School:
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pancreatic cancer chemoradiotherapy chemotherapy FOLFIRINOX gemcitabine |
Additional relevant MeSH terms:
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Pancreatic Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Gemcitabine Folfirinox |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |