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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

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

oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly

ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT

Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly

ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT

Yen-Shen Shen, M.D.

Chih-Hung Hsu, Ph.D.

Ruey-Kuen Hsieh, M.D.

Jen-Shi Chen, M.D.

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.

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.

A Phase II Study of Locally Advanced Pancreatic Cancer

A Phase II Randomized Study of Induction Chemotherapy Followed by Concurrent Chemo-radiotherapy in Locally Advanced Pancreatic Cancer

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.

National Taiwan University Hospital

National Cheng-Kung University Hospital

National Health Research Institutes, Taiwan

Spots Global Cancer Trial Database for ict of gemcitabine,oxapliplatin, leucovorin, and fluorouracil + ccrt