A randomised phase II trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in second-line treatment of advaneced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy

A randomised phase II trial of combined therapy with CPT-11/CDDP versus CPT-11 alone in second-line treatment of advaneced or recurrent gastric cancer resistant to Docetaxel/Cisplatin/TS-1 (DCS) therapy - A randomized phase II study of CPT-11/CDDP versus CPT-11 in second-line treatment of advanced/recurrent gastric cancer after DCS chemotherapy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003141

Enrollment

Registered

2010-02-06

Start date

2009-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Interventions

CPT-11+CDDP CPT-11 60mg/m2 d1 CDDP 30mg/m2 d1 repeat every 2weeks until PD CPT-11 alone CPT-11 150mg/m2 d1 repeat every 2weeks until PD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Histologically proven advaneced or recurrent gastric cancer gastric adenocarcinoma. (2) Tumor progression during or after DCS chemotherapy given as initial chemotherapy (patients with progressive disease: PD). Patients who have discontinued treatment because of adverse events were excluded. (3) No previous treatment other than DCS chemotherapy or surgery. (4) Received at least 1 course of DCS chemotherapy (5) Previous DCS chemotherapy completed at least 4 weeks before. (6) Measurable lesions according to RECIST guidelines. (7) Age > 20 and <80 years old (8) ECOG performance status 0-2 (9) Life expectancy over 3 months (10) Adequate organ function. * WBC >=;3500/mm3 and=<;12,000 mm3. * Neutrophil count >=2,000/mm3. * Platelet count>=;100,000/mm3. * Hemoglobin>=;8.0 g/dL Liver function tests * AST (GOT) and ALT (GPT)=<;x 2.5 upper limet. * Total bilirubin=<;1.50 mg/dL. Renal function test * Serum creatinine=<;1.50 mg/dL. (10) Written informed consent.

Exclusion criteria

Exclusion criteria: (1) With uncontrolled pleural effusion or ascites. (2) Active concomitant malignancy. (3) With infectious disease which needs treatment. (4) Uncontrolled medical conditions (e.g., congestive heart failure, ileus, interstitial pneumonia, pulmonary fibrosis, diabetes, interstitial pneumonia, pulmonary fibrosis, renal failure). (5) Watery stool (diarrhea). (6) With a history of mental disorder. (7) Pregnant or lactating women and women of child bearing potential not using contraception. (8) Drug hypersensitivity or severe drug allergy. (9) Inappropriate recruit to the study judged by an investigator in charge.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
safety,response rate,overall survival,Time to Treatment Failure	—

Countries

Japan

Contacts

Public ContactYasushis Sato

Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)

yasushis@sapmed.ac.jp011-611-2111(ext.3254)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026