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

Randomized Phase II Study Comparing Gemcitabine/S-1 Combination Chemoradiotherapy With Gemcitabine/S-1 Combination Chemotherapy for Unresectable 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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Drug: gemcitabine, S-1; Drug: gemcitabine, S-1, radiotherapy

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Osaka, Japan, 537-8511
    • Osaka Medical Center for Cancer and Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.; Other Names: TS-1; gemzer
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.; Other Names: TS-1; gemzer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Two year survival rate	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Osaka Medical Center for Cancer and Cardiovascular Diseases
• Investigators: Study Director: Tatsuya Ioka, MD, Osaka Medical Center for Cancer and CVD

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: September 5, 2011
• First Submitted That Met QC Criteria: September 6, 2011
• First Posted (Estimate): September 7, 2011

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 19, 2017
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Gemcitabine
• Other Study ID Numbers: TatsuyaIoka; UMIN000001990 (Registry Identifier: UMIN)