Clinical trial · Interventional
Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer
A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)
NCT01946646CI-TRIAL-00025526SR-GSterminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): slow recruitment
Summary
Brief summary (as posted)
The purpose of this study is to determine whether combination of TS-1 and concurrent and short-course radiotherapy is feasible in metastatic pancreatic cancer. The rationale of this study primarily bases on the good efficacy of gemcitabine plus TS-1 and the great potential of local control of concurrent chemoradiotherapy in pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1-CCRT | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- S-1-CCRT
- description
- There are five dose levels and one arm only. Level 1: S-1, 25 mg/m2, bid, Day 1-14; RT 25 Gy/10 fx, Day 1-5, 8-12 Level 2: S-1, 25 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 3: S-1, 30 mg/m2, bid, Day 1-14; RT 30 Gy/10 fx, Day 1-5, 8-12 Level 4: S-1, 30 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 Level 5: S-1, 35 mg/m2, bid, Day 1-16; RT 36 Gy/12 fx, Day 1-5, 8-12, 15-16 All dose levels are followed by Gemcitabine/S-1 (G 1000 mg/m2, iv, D1 and 15 plus S-1 60/80/100 mg/day based on BSA, po, D1-7, D15-21, q4w) after the CCRT
- interventionNames
- Drug: S-1-CCRT
Primary outcomes (2)
- measure
- maximum tolerated dose
- timeFrame
- 6 weeks
- description
- Dose-limiting toxicities (DLT) are defined as the following manifestations of toxicity observed until completion of CCRT: 1. grade 3 leucopenia and/or neutropenia with a fever ≥ 38°C lasting 3 days or more 2. grade 3 leucopenia and/or neutropenia with infection 3. grade 4 leucopenia and/or neutropenia lasting 3 days or more 4. grade 4 leucopenia and/or neutropenia requiring G-CSF 5. platelet \< 25,000/mm3 6. , grade 3 thrombocytopenia requiring transfusion 7. hemoglobin \< 8.0 g/dL g. serum AST/ALT ≥ 10 times ULN h. total bilirubin ≥ 3 times ULN i. creatinine \>3.0 - 6.0 times ULN (grade 3) i. grade 3 or 4 nonhematological toxicities including nausea, vomiting, anorexia, fatigue, constipation, hyperglycemia, and abnormality of sodium, potassium, and calcium If three or more patients experience DLT at a given dose level, then the previous dose level will be considered as the MTD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * histologically or cytologically proven, newly diagnosed pancreatic adenocarcinoma or adenosquamous carcinoma * no previous radiotherapy, chemotherapy, targeted therapy, curative surgery, or immunotherapy used for pancreatic cancer * presence of at least one measurable lesion, which must meet the criteria of being ≥ 20 mm in at least one dimension by conventional CT/MRI or ≥ 10 mm by spiral CT scan * age between 20 and 79 years at registration * ECOG PS of 0 or 1 * adequate major organ functions * ability to take the oral study medication (TS-1) * no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration * voluntarily signed the written informed consent form Exclusion Criteria: * pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration * presence of diarrhea ≥ CTCAE v.4.03 grade 2 * concomitant active infection or significant co-morbid medical conditions * moderate or severe ascites or pleural effusion that requires drainage * central nervous system metastasis * prior or concurrent malignancies within the last 3 years * concomitant treatment with flucytosine, phenytoin or warfarin * pregnant women or nursing mothers, or positive pregnancy test * severe mental disorder * judged ineligible by physician for participation in the study due to safety concern
References
Publications (0)
Data not yet available
No reference posted for this study.