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

Phase 2
20 Years
80 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Randomized Phase II Study Comparing 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.

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


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two year survival rate

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Tatsuya Ioka, MD

Investigator Role:

Study Director

Investigator Affiliation:

Osaka Medical Center for Cancer and CVD


Japan: Institutional Review Board

Study ID:




Start Date:

April 2009

Completion Date:

December 2014

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms