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

July 30, 2011
September 22, 2013
July 2011
December 2014   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01412294 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer
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)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastric Cancer
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.

Experimental: Capecitabine, Cisplatin
Intervention: Drug: Capecitabine, Cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 2015
December 2014   (final data collection date for primary outcome measure)

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

Both
20 Weeks to 74 Years
No
Contact: Junichi Sakamoto sakamjun@med.nagoya-u.ac.jp
Japan
 
NCT01412294
ECRIN-GC1106-XParTS, UMIN000005857
Yes
Epidemiological and Clinical Research Information Network
Epidemiological and Clinical Research Information Network
Not Provided
Principal Investigator: Akira Tsuburaya Shonan Kamakura Hospital
Epidemiological and Clinical Research Information Network
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP