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Trial record 81 of 851 for:    Pancreatic Cancer AND Metastatic Pancreatic Cancer

Phase I Study of TS-1 With Concurrent Radiotherapy to Treat Pancreatic Cancer (SR-GS)

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ClinicalTrials.gov Identifier: NCT01946646
Recruitment Status : Terminated (slow recruitment)
First Posted : September 19, 2013
Last Update Posted : January 18, 2017
Sponsor:
Collaborator:
TTY Biopharm
Information provided by (Responsible Party):
National Taiwan University Hospital

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.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: S-1-CCRT Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of TS-1 With Concurrent Radiotherapy Followed by Gemcitabine and TS-1 in Metastatic Pancreatic Cancer (SR-GS Study)
Study Start Date : October 2013
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: S-1-CCRT
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
Drug: S-1-CCRT



Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 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.


  2. maximum-tolerated dose [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946646


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
TTY Biopharm

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01946646     History of Changes
Other Study ID Numbers: 201211048MPC
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Digestive System Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs