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Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies

Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies - Multicenter phase II study of oral S-1 monotherapy in advanced colorectal cancer who have failed prior oxaliplatin and irinotecan-based therapies <CCOG-1103 (C3-01)>

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000006487
Enrollment
34
Registered
2011-10-06
Start date
2011-10-01
Completion date
Unknown
Last updated
2025-07-18

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

Conditions

Colorectal cancer

Interventions

Sponsors

Chube Clinical Oncology Group (CCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria:

Exclusion criteria

Exclusion criteria: (1) Uncontrolled infection. (2) Patient with symptomatic cardiovascular disease or asymptomatic disease but have been treated (>=Grade 2 according to NCI-CTCAE ver.4). History of myocardial infarction within a year. (3) Severe lung disease. (4) Interstitial lung disease or pulmonary fibrosis. (5) Severe liver disease. (6) Severe renal failure, or urinary protein (more than 2+). (7) Previous history of severe drug-induced allergy (8) ileus, bowel obstruction (9) Uncontrolled severe complications (DM, hypertension, diarrhea, et al.). (10) History of active double cancer. (11) Massive pleural effusion or ascites that required drainage. (12) Brain metastasis (13) Pregnant women, possibly pregnant women, wishing to become pregnant, and nursing mothers. (14) Not appropriate for the study at the physician's assessment.

Design outcomes

Primary

MeasureTime frame
Progression free survival

Secondary

MeasureTime frame
One year survival rate, Overall survival, Response rate, Disease control rate, Time to treatment failure, Toxicity

Countries

Japan

Contacts

Public ContactTakahiro Asada, Koji Torii

Nagoya University Gradeate School of Medicine Department of Gastroenterology

goro@med.nagoya-u.ac.jp052-744-2250

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026