XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2011 by Epidemiological and Clinical Research Information Network
Sponsor:
Information provided by (Responsible Party):
Epidemiological and Clinical Research Information Network
ClinicalTrials.gov Identifier:
NCT01412294
First received: July 30, 2011
Last updated: September 22, 2013
Last verified: August 2011
  Purpose

The aim of this study is to evaluate efficacy and safety of Capecitabine/Cisplatin for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.


Condition Intervention Phase
Gastric Cancer
Drug: Capecitabine, Cisplatin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate Efficacy and Safety of Capecitabine/Cisplatin Combination Therapy in Gastric Cancer Patients Who Relapsed After S-1 Adjuvant Chemotherapy (XParTS)

Resource links provided by NLM:


Further study details as provided by Epidemiological and Clinical Research Information Network:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: July 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Capecitabine, Cisplatin Drug: Capecitabine, Cisplatin

Drug: Capecitabine Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.

Drug: Cisplatin Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle.


Detailed Description:

S-1/Cisplatin (SP) is one of the standard treatments of advanced gastric cancer. However, evidence of SP on gastric cancer recurrence after adjuvant therapy by the same drug (S-1) is not established. The aim of this study is to evaluate the efficacy and safety of Capecitabine/Cisplatin (XP) for gastric cancer patients who relapsed after adjuvant chemotherapy by S-1.

  Eligibility

Ages Eligible for Study:   20 Weeks to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Recurrent gastric cancer histologically confirmed as being adenocarcinoma
  2. Age of 20 to 74 years with either gender
  3. ECOG Performance Status of 0 to 2
  4. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
  5. Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period
  6. Less than 6 months treatment-free interval from completion of adjuvant therapy
  7. In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2
  8. Treatment-naïve recurrent gastric cancer
  9. Life expectancy of at least 3 months after registration
  10. Written informed consent
  11. Adequate major organ functions within 14 days before registration

    Exclusion Criteria:

  12. Positive HER2 status
  13. Previous treatment with platinum agents after curative surgery
  14. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
  15. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
  16. More than one cancer at the same time or more than one cancer at different times separated by a 5-year disease-free interval. However, multiple active cancers do not include carcinoma in situ or skin cancer which is determined to have been cured as a result of treatment.
  17. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
  18. Active hepatitis
  19. Heart disease that is serious or requires hospitalization, or history of such disease within past year

9) Concurrent illness that is serious or requires hospitalization (intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes mellitus, renal failure, liver disorders, or hepatic cirrhosis)

10) Being treated or in need of treatment with phenytoin or warfarin potassium

11) Chronic diarrhea (watery stool or ≥ 4 times/day)

12) Active gastrointestinal hemorrhage

13) Body cavity fluids requiring drainage or other treatment

14) Clinical suspicion or previous history of metastases to brain or meninges

15) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) Unwillingness to practice contraception

17) Poor oral intake

18) Psychiatric disorders which are being or may need to be treated with psychotropics

19) Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412294

Contacts
Contact: Junichi Sakamoto sakamjun@med.nagoya-u.ac.jp

Locations
Japan
Epidemiological and Clinical Research Information Network Recruiting
Kyoto, Japan, 606-8392
Principal Investigator: Akira Tsuburaya         
Sponsors and Collaborators
Epidemiological and Clinical Research Information Network
Investigators
Principal Investigator: Akira Tsuburaya Shonan Kamakura Hospital
  More Information

No publications provided

Responsible Party: Epidemiological and Clinical Research Information Network
ClinicalTrials.gov Identifier: NCT01412294     History of Changes
Other Study ID Numbers: ECRIN-GC1106-XParTS, UMIN000005857
Study First Received: July 30, 2011
Last Updated: September 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Epidemiological and Clinical Research Information Network:
gastric cancer
recurrent gastric cancer
adenocarcinoma of the stomach
capecitabine
xp

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014