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

Sponsor
Epidemiological and Clinical Research Information Network (Other)
Overall Status
Unknown status
CT.gov ID
NCT01406249
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
76
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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)
Study Start Date :
Aug 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival rate [at 24weeks from patient enrollment]

Secondary Outcome Measures

  1. Time-to treatment failure [3year]

  2. Response rate [3 year]

  3. Overall survival [3 year]

  4. Safety [3 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Epidemiological and Clinical Research Information Network
ClinicalTrials.gov Identifier:
NCT01406249
Other Study ID Numbers:
  • ECRIN-GC1107-XParTS II
  • UMIN000006045
First Posted:
Aug 1, 2011
Last Update Posted:
Jul 27, 2017
Last Verified:
Jul 1, 2017
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

Study Results

No Results Posted as of Jul 27, 2017