Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer
Recruitment status was: Active, not recruiting
|Pancreatic Cancer||Drug: Drug: gemcitabine, S-1 Drug: gemcitabine, S-1, radiotherapy||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable Locally Advanced Pancreatic Cancer.|
- Two year survival rate [ Time Frame: 2 years ]
- Progression free survival（PFS） [ Time Frame: 4 years ]
- Overall Survival (OS) [ Time Frame: 4 years ]
- Adverse events [ Time Frame: 4 years ]
- Response rate [ Time Frame: 4 years ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||September 2015|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Gemcitabine , S-1
Gemcitabine 1000mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks
Drug: Drug: gemcitabine, S-1
Gemcitabine 1,000mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks.
Experimental: Gemcitabine, S-1, radiotherapy
Gemcitabine 600mg/m2 on Day 1 and 8, every 3 weeks. S-1 60-100mg/day on Day 1 to 14, every 3 weeks with radiotherapy 50.4Gy in 28 fractions
Drug: gemcitabine, S-1, radiotherapy
Gemcitabine 600mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
When cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. Generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular.
In comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. In the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. This decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt.
We will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or S-1, not 5FU, predominantly from our own clinical trials on this occasion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430052
|Osaka Medical Center for Cancer and Cardiovascular Diseases|
|Osaka, Japan, 537-8511|
|Study Director:||Tatsuya Ioka, MD||Osaka Medical Center for Cancer and CVD|