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Tolerability test of TS-1 / CBDCA combination therapy for postoperative stage II / IIIA non-small cell lung cancer complete resection

Tolerability test of TS-1 / CBDCA combination therapy for postoperative stage II / IIIA non-small cell lung cancer complete resection - Tolerability test of TS-1 / CBDCA combination therapy for postoperative stage II / IIIA non-small cell lung cancer complete resection

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016766
Enrollment
40
Registered
2015-03-11
Start date
2013-04-01
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

Non-small cell lung cancer

Interventions

As adjuvant chemotherapy, we do four courses the TS-1 / CBDCA combination therapy: two weeks of rest after two weeks of treatment.

Sponsors

Department of Surgery II, University of Fukui
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The patient was diagnosed with pathologically non-small cell lung cancer, is a pathological stage II / IIIA. 2) The patient has been confirmed pathologically complete resection. 3) In cases of lobectomy or more surgical resection was performed, has also been done lymph node dissection. 4) For non-small cell lung cancer, before treatment (chemotherapy or radiation therapy) other than surgery is not. 5) Performance Status (PS) of ECOG is 0-1. 6) Oral ingestion is possible cases. 7) To have sufficient bone marrow, liver, kidney, and lung function within registration before the 14th. 8) Chemotherapy within 56 days after surgery can begin. 9) Consent document from the patient is obtained.

Exclusion criteria

Exclusion criteria: 1) TS-1 or CBDCA is contraindicated administration. 2) Patients with a history of severe drug hypersensitivity. 3) Patients with obvious interstitial pneumonia or pulmonary fibrosis in the chest X-ray. 4) Patients with metachronous or simultaneity of active multiple cancer. 5) Patients with pleural effusion and ascites and pericardial reservoir requiring drainage. 6) Patients with the following serious complications. 1. Intestinal paralysis, intestinal obstruction 2. Poor control of diabetes or hypertension 3. Cirrhosis, liver failure 4. Renal failure 5. Active infection 6. Heart failure or myocardial infarction within 6 months 7. Other complications, it is determined to cause a serious problem in the treatment enforcement 7) Patients with severe diarrhea. 8) Pregnant women or women that might be pregnant. 9) Other cases attending physician it is determined unsuitable for registration of the study.

Design outcomes

Primary

MeasureTime frame
Completion rate of treatment

Countries

Japan

Contacts

Public ContactKayo Sakon

University of Fukui Department of Surgery II

ksakon@u-fukui.ac.jp0776-61-3111

Outcome results

None listed

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