Chemoradiotherapy With Gemcitabine/S-1 Vs Gemcitabine/S-1 For Locally Advanced Pancreatic Cancer

Study Overview

Chemoradiotherapy With Gemcitabine/S-1 vs Gemcitabine/S-1 for Locally Advanced Pancreatic Cancer

The purpose of this study is to evaluate the clinical effectiveness of Gemcitabine/S-1 combination chemoradiotherapy with Gemcitabine /S-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

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.

Pancreatic Cancer

DRUG: Drug: gemcitabine, S-1
DRUG: gemcitabine, S-1, radiotherapy

TatsuyaIoka
UMIN000001990 (REGISTRY Identifier) (REGISTRY: UMIN)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2011-09-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2017-11-19
First Submitted that Met QC Criteria 2011-09-06	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2017-11-21
First Posted (ACTUAL) 2011-09-07	Results First Posted N/A	Last Verified 2015-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: 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.

Participant Group/Arm

Intervention/Treatment

OTHER: 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.

Primary Outcome Measures	Measure Description	Time Frame
Two year survival rate		2 years

Secondary Outcome Measures	Measure Description	Time Frame
Progression free survival（PFS）		4 years
Overall Survival (OS)		4 years
Adverse events		4 years
Response rate		4 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

Involving over 1/2 circumference of major artery (SMA/CA). (Under 1/2 that was borderline lesion.)
Involving over the merging section of portal-SMV.
No distal metastasis with diagnostic imaging.
Confirmed by CT image performed with in four weeks before registration. 3. Performance Status:0-1(ECOG) 4. Patients of age =>20 and 80> 5. sufficient organ functions

neutrophils>=1,500/mm3
platelets>=100,000/mm3
hemoglobin>=9.0g/dl
AST(GOT)/ALT(GPT) <=150IU
total bilirubin <=2.0mg/dl, (or <=3.0mg/dl if biliary drainage were present)
serum creatinine <= 1.2mg/dl
creatinine clearance>=60ml/min 6. Life expectancy more than 3 months. 7. Written informed consent.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Tatsuya Ioka, MD, Osaka Medical Center for Cancer and CVD

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record