XParTS: Capecitabine/Cisplatin(XP) for Recurrent Gastric Cancer

NCT01412294 | Unknown Phase 2 DMC

• 2 other identifiers: ECRIN-GC1106-XParTSUMIN000005857
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

gastric cancer; recurrent gastric cancer; adenocarcinoma of the stomach; capecitabine; xp

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  2 year

Secondary Outcomes (4)

• Overall survival

  2 year

• Response rate

  2 year

• Time to treatment failure

  2 year

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2 year

Study Arms (1)

Capecitabine, Cisplatin

EXPERIMENTAL

Drug: Capecitabine, Cisplatin

Interventions

Capecitabine, Cisplatin DRUG

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.

Capecitabine, Cisplatin

Eligibility Criteria

• Age: 20 Weeks - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• \) 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)
• \) Being treated or in need of treatment with phenytoin or warfarin potassium
• \) Chronic diarrhea (watery stool or ≥ 4 times/day)
• \) Active gastrointestinal hemorrhage
• \) Body cavity fluids requiring drainage or other treatment
• \) Clinical suspicion or previous history of metastases to brain or meninges
• \) Women who are pregnant, breastfeeding, or potentially (hoping to become) pregnant 16) Unwillingness to practice contraception

Sponsors & Collaborators

• Epidemiological and Clinical Research Information Network: lead

Study Sites (1)

Epidemiological and Clinical Research Information Network

Kyoto, 606-8392, Japan

Location

Related Publications (1)

• Nishikawa K, Tsuburaya A, Yoshikawa T, Takahashi M, Tanabe K, Yamaguchi K, Yoshino S, Namikawa T, Aoyama T, Rino Y, Kawada J, Tsuji A, Taira K, Kimura Y, Kodera Y, Hirashima Y, Yabusaki H, Hirabayashi N, Fujitani K, Miyashita Y, Morita S, Sakamoto J. A phase II trial of capecitabine plus cisplatin (XP) for patients with advanced gastric cancer with early relapse after S-1 adjuvant therapy: XParTS-I trial. Gastric Cancer. 2018 Sep;21(5):811-818. doi: 10.1007/s10120-018-0815-0. Epub 2018 Feb 27.

  PMID: 29488122 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Capecitabine; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Akira Tsuburaya

  Shonan Kamakura Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2011
• First Posted: August 9, 2011
• Study Start: July 1, 2011
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

JP (1)