XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Epidemiological and Clinical Research Information Network
ClinicalTrials.gov Identifier:
NCT01406249
First received: July 28, 2011
Last updated: September 22, 2013
Last verified: September 2013
  Purpose

The aim of this study is to elucidate the efficacy and safety of XP and SP for first-line treatment of Advanced Gastric Cancer.


Condition Intervention Phase
Gastric Cancer
Drug: SP
Drug: XP
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Comparing Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer (XParTS II)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival rate [ Time Frame: at 24weeks from patient enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time-to treatment failure [ Time Frame: 3year ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 3 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: S-1,Cisplatin Drug: SP

Drug: S-1:

S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle.

Drug: Cisplatin:

Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle.

Experimental: Capecitabine, Cisplatin Drug: XP

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:

XP and SP are either standard treatment for advanced gastric cancer. The aim of this study is to elucidate the efficacy and safety of Capecitabine/Cisplatin and S-1/Cisplatin for first-line treatment of Advanced Gastric Cancer.

  Eligibility

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

Inclusion Criteria:

  1. Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
  2. Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
  3. No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
  4. ECOG Performance Status of 0 to 2
  5. Life expectancy of at least 3 months after registration
  6. Written informed consent
  7. Age of 20 to 74 years with either gender
  8. Adequate Major organ functions within 14 days before registration

Exclusion Criteria:

  1. Positive HER2 status
  2. Previous history of fluoropyrimidines therapy within 6 months prior to registration
  3. Previous treatment with platinum agents
  4. Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
  5. Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
  6. 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.
  7. Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
  8. Active hepatitis
  9. Heart disease that is serious or requires hospitalization, or history of such disease within past year
  10. Having complication 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)
  11. Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
  12. Chronic diarrhea (watery stool or ≥4 times/day)
  13. Active gastrointestinal bleeding
  14. Body cavity fluids requiring drainage or other treatment
  15. Clinical suspicion or previous history of metastasis to brain or meninges
  16. Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
  17. Unwillingness to practice contraception
  18. Poor oral intake
  19. Psychiatric disorders which are being or may need to be treated with psychotropics
  20. 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: NCT01406249

Locations
Japan
Epidemiological and Clinical Research Information Network
Kyoto, Japan, 606-8392
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: NCT01406249     History of Changes
Other Study ID Numbers: ECRIN-GC1107-XParTS II, UMIN000006045
Study First Received: July 28, 2011
Last Updated: September 22, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Epidemiological and Clinical Research Information Network:
unresectable gastric cancer
recurrent gastric cancer
StageIV gastric cancer
adenocarcinoma of the stomach
XP
SP

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

ClinicalTrials.gov processed this record on August 18, 2014