Induction Chemotherapy, FOLFIRINOX Followed With Concurrent Capecitabine and Radiation Therapy in Inoperable Locally Advanced Cancer of the Pancreas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02311439|
Recruitment Status : Unknown
Verified December 2014 by Ahmed Allam Abdelhamed Mohamed, Assiut University.
Recruitment status was: Recruiting
First Posted : December 8, 2014
Last Update Posted : December 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cancer of Pancreas||Drug: FOLFIRINOX + CRT||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Induction Chemotherapy, Fluorouracil, Leucovorin, Oxaliplatin and Irinotecan (FOLFIRINOX) Followed With Concurrent Capecitabine and Radiation Therapy in Treatment of Patients With Inoperable Locally Advanced Cancer Pancreas|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||April 2017|
Experimental: FOLFIRINOX + CRT
FOLFIRINOX regimen, consisted of oxaliplatin, irinotecan, leucovorin and fluorouracil (5-FU), for 4 cycles, followed by consolidation radiotherapy concurrent with capecitabine 625mg/m2 BID in non-progressed cases, in treating patients with locally advanced cancer pancreas.
Drug: FOLFIRINOX + CRT
Induction 4 times chemotherapy, FOLFIRINOX regimen, consisted of Oxaliplatin at a dose of 85 mg/m2 D1, 2-hour I.V + Irinotecan 180 mg/m2 D1 90-minute I.V. + Leucovorin 200 mg/m2 2- hour I.V, D1,2 + (5-FU) dosed at 400 mg/m2, administered as an intravenous bolus on day 1 and day 2, followed by a continuous intravenous infusion of 600 /m2 over a 20- hours period on day 1 and day 2. Treatment will be administered every 2 weeks. G-CSF will be administrated according to the need.
In non-progressed cases, will be followed by consolidation concurrent radiotherapy with capecitabine 625 mg/m2 BID.
A fractionated dose of 50.4Gy /28 fractions/15 MeV photon energy generated by Dual-energetic Linear Accelerator.
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability of FOLFIRINOX plus Concurrent Radiotherapy with Capecitabine [ Time Frame: 6 months after enrolment ]will be carried out, using (CTCAE) Common Terminology Criteria for Adverse Events, Version 4.0
- Tumor response [ Time Frame: 6 months after enrolment ]will be carried out, using (RECIST) Response Evaluation Criteria In Solid Tumors, Version 1.1
- Progression Free Survival [ Time Frame: 6 months after finishing protocol ]
- Number of Cases will have radical surgery [ Time Frame: 6 months after enrolment ]
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): NCT02311439
|Contact: Ahmed Mohamed, MScemail@example.com|
|Assiut University Hospitals||Recruiting|
|Asyut, Egypt, 71516|
|Contact: Samir Eid, Professor firstname.lastname@example.org|