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

NCT ID: NCT01430052

Last Updated: 2017-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Drug: gemcitabine, S-1

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

gemcitabine, S-1, radiotherapy

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

gemzer; TS-1; gemzer; TS-1

Eligibility Criteria

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer.

2. Patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below.

• 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.

Exclusion Criteria

1. Lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings.

2. Watery diarrhea

3. Severe infection

4. Severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc)

5. Massive pleural or abdominal effusion.

6. Metastasis to central nervous system.

7. Active synchronous or metachronous malignancy other than carcinoma in situ.

8. Regular use of flucytosine, fenitoin or warfarin

9. Pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy

10. Severe mental illness

11. Patients who are judged inappropriate for the entry into the study by the investigator.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osaka Medical Center for Cancer and Cardiovascular Diseases

OTHER

Sponsor Role: lead

Responsible Party

Tatsuya Ioka

Assistant director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tatsuya Ioka, MD

Role: STUDY_DIRECTOR

Osaka Medical Center for Cancer and CVD

Locations

Osaka Medical Center for Cancer and Cardiovascular Diseases

Osaka, , Japan

Countries

Japan

Other Identifiers

UMIN000001990

Identifier Type: REGISTRY

Identifier Source: secondary_id

TatsuyaIoka

Identifier Type: -

Identifier Source: org_study_id