XParTS II: Capecitabine/CDDP(XP) and S-1/CDDP(SP) as the First-line Treatment for Advanced Gastric Cancer
This study is not yet open for participant recruitment.
Verified July 2011 by Epidemiological and Clinical Research Information Network
Sponsor:
Epidemiological and Clinical Research Information Network
Information provided by (Responsible Party):
Epidemiological and Clinical Research Information Network
ClinicalTrials.gov Identifier:
NCT01406249
First received: July 28, 2011
Last updated: August 18, 2011
Last verified: July 2011
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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 2014 |
| Estimated Primary Completion Date: | June 2013 (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:
- Histologically confirmed gastric adenocarcinoma with unresectable metastatic or recurrent disease
- Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
- No previous chemotherapy or radiotherapy. However, adjuvant chemotherapy is allowed the case of more than 6 months from the end of adjuvant chemotherapy
- ECOG Performance Status of 0 to 2
- Life expectancy of at least 3 months after registration
- Written informed consent
- Age of 20 to 74 years with either gender
- Adequate Major organ functions within 14 days before registration
Exclusion Criteria:
- Positive HER2 status
- Previous history of fluoropyrimidines therapy within 6 months prior to registration
- Previous treatment with platinum agents
- Previous history of serious hypersensitivity to fluoropyrimidines or platinum agents
- Previous history of adverse reactions suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency
- 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.
- Obvious infection or inflammation (pyrexia ≥ 38.0˚C)
- Active hepatitis
- Heart disease that is serious or requires hospitalization, or history of such disease within past year
- 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)
- Being treated or in need of treatment with flucytosine, phenytoin or warfarin potassium
- Chronic diarrhea (watery stool or ≥4 times/day)
- Active gastrointestinal bleeding
- Body cavity fluids requiring drainage or other treatment
- Clinical suspicion or previous history of metastasis to brain or meninges
- Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant
- Unwillingness to practice contraception
- Poor oral intake
- Psychiatric disorders which are being or may need to be treated with psychotropics
- Otherwise determined by investigators or site principal investigators to be unsuitable for participation in study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406249
Contacts
| Contact: Junichi Sakamoto | sakamjun@med.nagoya-u.ac.jp |
Locations
| Japan | |
| Epidemiological and Clinical Research Information Network | Recruiting |
| Kyoto, Japan, 606-8392 | |
Sponsors and Collaborators
Epidemiological and Clinical Research Information Network
Investigators
| Principal Investigator: | Akira Tsuburaya | Kanagawa cancer center |
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: | August 18, 2011 |
| 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 Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013