Status:
UNKNOWN
XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer
Lead Sponsor:
Epidemiological and Clinical Research Information Network
Conditions:
Gastric Cancer
Eligibility:
All Genders
20-74 years
Phase:
PHASE2
Brief Summary
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.
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. ...
Eligibility Criteria
Inclusion
- Recurrent gastric cancer histologically confirmed as being adenocarcinoma
- Age of 20 to 74 years with either gender
- ECOG Performance Status of 0 to 2
- Lesions confirmed on imaging within 28 days before registration (not required measurable lesions as defined in RECIST version 1.1)
- Post-gastrectomy adjuvant chemotherapy including S-1 for at least 12 weeks including interruption period
- Less than 6 months treatment-free interval from completion of adjuvant therapy
- In case with receiving neoadjuvant chemotherapy, the total dose of CDDP does not exceed 120mg/m2
- Treatment-naïve recurrent gastric cancer
- Life expectancy of at least 3 months after registration
- Written informed consent
- Adequate major organ functions within 14 days before registration
Exclusion
- Positive HER2 status
- Previous treatment with platinum agents after curative surgery
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01412294
Start Date
July 1 2011
End Date
December 1 2017
Last Update
July 27 2017
Active Locations (1)
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1
Epidemiological and Clinical Research Information Network
Kyoto, Japan, 606-8392