A Phase II Study of Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT01867892|
Recruitment Status : Unknown
Verified May 2013 by National Health Research Institutes, Taiwan.
Recruitment status was: Enrolling by invitation
First Posted : June 4, 2013
Last Update Posted : June 4, 2013
The primary end point is to evaluate the 9-month progression free survival rate and safety profile after FOLFIRINOX versus GOFL induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer.
The secondary end points are to evaluate the disease control rate, overall survival time, toxicity profile and compliance after induction chemotherapy and concurrent chemoradiotherapy as well as the disease control rate after inductional chemotherapy alone in locally advanced pancreatic cancer. Translational research including pharmacogenomic study and biomarker study will also be done concomitantly.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT Drug: ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT||Phase 2|
Patients should be randomized to two study arms stratified by resectability status (borderline resectable and unresectable) after enrollment. Eligible patients will be randomly assigned on a 1:1 basis to either of two study groups, using a central randomization procedure with stratification according to NCCN criteria of resectability.
After randomization, induction chemotherapy (ICT) will be administered for 3 cycles (3 months). Patients who have radiological evidence of distant dissemination will be shifted to salvage chemotherapy. Patients who have responsive, stable disease as well as those with localized progressive disease after ICT will receive concurrent chemoradiotherapy (CCRT) 3-4 weeks after the last dose of ICT. Surgical evaluation will be performed 4-6 weeks after the completion of CCRT. Patients who have respectable disease will undergo surgical resection. Postoperative adjuvant chemotherapy for 3 cycles (3 months) will be given for those who are considered to have curative resection. Patients who still have unresectable disease or non-curative resection will receive systemic chemotherapy till disease progression or unacceptable toxicity.
For Arm 1, ICT with FOLFIRINOX ( oxaliplatin 85mg/m2 for 2 hr, irinotecan 180mg/m2 for 90 min and 5FU 3000mg/m2 + LV 150mg/m2 continuous infusion 48 hr) will be administered biweekly. For Arm 2, ICT with GOFL ( 800mg/m2 gemcitabine at a fixed rate of 10mg/m2/min followed by a 2-hour oxaliplatin 85mg/m2 and then a 48-hour 3000mg/m2 5-FU and 150 mg/m2 leucovorin on day 1 and 15 every 28 days/cycle) will be given biweekly.
After three 3 cycles of ICT, patients without distant metastasis will be given CCRT with 5-FU 450mg/m2 in Arm 1, gemcitabine 400mg/m2 in Arm 2, 2 hrs before RT on day1,8,15,22,29,36. Radiation will be given 180cGy per day, 5 days a week for 28 fractions to totally 5040cGy.
If complete surgical resection is feasible, optimal surgery will be performed 4-6 weeks after CCRT. If complete surgical resection is impossible, biopsy with or without bypass surgery may be performed. Patients who have curative surgical resection will receive additional 6 cycles ( 6 months) of adjuvant chemotherapy ( Arm1, FOLFIRINOX, Arm 2, GOFL) within 4 weeks after surgery and then followed up until tumor progression. Patients who are not feasible for curative resection, will receive continued chemotherapy (Arm1, FOLFIRINOX; Arm2, GOFL) 3-4 weeks after CCRT complete. The regimen will continue till disease progression.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||May 2019|
Experimental: ICT of oxaliplatin,irinotecan,5-FU and leucovorinon and CCRT
Arm1:oxaliplatin,irinotecan,5-FU and leucovorinon D1,15 every 28days for 3 cycles,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly
Drug: ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT
oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly
Other Name: ICT of oxapliplatin,irinotecan,leucovorin,and fluorouracil and CCRT
Active Comparator: ICT of gemcitabine,oxaliplatin,5-FU,leucovorin and CCRT
Arm 2:gemcitabine,oxaliplatin,5-FU,leucovorin on D1,15 every 28 days for 3 cycles,Evaluation of Tumor Response,CR/PR/SD or localized disease RT 5,040cGy in 28 fractions/ 5.5 wks Arm 2: Gem 400mg/m2 iv 40min weekly
Drug: ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT
Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly
Other Name: ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil +CCRT
- the response rate, disease control rate, overall survival, and patients' quality of life. [ Time Frame: 4.5 years ]This is a randomized phase II trial of ICT followed by CCRT with radiotherapy in LAPC. The efficacy will be primarily measured by progression free survival (PFS) as defined in Section 8.5.Other measurements include the response rate, disease control rate, overall survival, and patients' quality of life as described in Section 8.We anticipate that the attrition rate is about 10%, hence, roughly 86 patients will be recruited , we anticipate that the recruitment will be completed in 4.5 years.
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): NCT01867892
|Principal Investigator:||Yen-Shen Shen, M.D.||National Cheng-Kung University Hospital|
|Principal Investigator:||Chih-Hung Hsu, Ph.D.||National Taiwan University Hospital|
|Principal Investigator:||Ruey-Kuen Hsieh, M.D.||Mackay Memorial Hospital|
|Principal Investigator:||Jen-Shi Chen, M.D.||Chang Gung Memorial Hospital|