Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer.

Randomized Phase II trial on conventional administration (continuous administration for 2 weeks followed by one week interval) and alternate-day administration of adjuvant chemotherapy drug TS-1 in patients who underwent complete resection of non-small cell lung cancer. - conventional administration (continuous administration for 2 weeks followed by one week interval) vs alternate-day administration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011210

Enrollment

Registered

2013-08-01

Start date

2013-08-01

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

lung cancer

Interventions

conventional administration (continuous administration for 2 weeks followed by one week interval) alternate-day administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Cases with a complete resection of primary non-small cell lung cancer. 2) Cases with histopathologically identified adenocarcinoma, large-cell cancer, squamous cell cancer and adenosquamous cancer. 3) Cases at stage I (excluding T1a) according to the New TNM Staging System for Lung Cancer (UICC-7) 4) Cases with age between 20 and 80 years old 5) Cases with performance status (ECOG scale) of between 0 and 1. 6) Cases with the following main organ functions 7) Cases in which chemotherapy can be performed within 8 weeks after surgery. 8) Cases in which no treatments excluding surgery have be performed. 9) Cases in which oral administration of drugs can be possible. 10) Cases in which a consent form to participate in the study has been signed by a patient.

Exclusion criteria

Exclusion criteria: 1) Cases in which apparent interstitial pneumonia or pulmonary fibrosis is observed by routine chest radiograph or chest CT. 2) Cases which require drainage of accumulated pleural fluid, ascetic fluid and effusion. 3) Cases with synchronous or metachronous active double cancer or multiple cancer. 4) Cases with complications which are hard to control (such as cardiac disease, liver disease, severe diabetes and hemorrhage). 5) Cases accompanied with diarrhea (watery diarrhea). 6) Patients who are pregnant or nursing or women who might be pregnant. 7) Male patients planning to have a child. 8) Patients with prior drug hypersenstitivity. 9) Patients with history of severe hypersensitivity to TS-1 components. 10) Patients who are undergoing a treatment with other fluorinated pyrimidine-type anti-tumor drugs. 11) Patients in which the administration of TS-1 is prohibited. 12) Patients who are undergoing a treatment with warfarin potassium, phenytoin or flucytosine. 13) Other cases which are determined to be unsuitable to this study

Design outcomes

Primary

Measure	Time frame
Treatment completion rate	—

Secondary

Measure	Time frame
Overall survival period (OS), Recurrence free survival period (RFS), Adverse effect occurrence rate, recurrence pattern	—

Countries

Japan

Contacts

Public ContactNoriyuki Matsutani

Teikyo University School of Medicine Surgery

matsutan@med.teikyo-u.ac.jp03-3964-1231

Outcome results

None listed

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