Metastatic Pancreatic Cancer
Conditions
Brief summary
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.
Interventions
DRUGS-1-CCRT
Sponsors
TTY Biopharm
National Taiwan University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum tolerated dose | 6 weeks | 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. |
| maximum-tolerated dose | 6 weeks | — |
Countries
Taiwan
Outcome results
None listed