A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor

A randomized controlled Phase II study comparing TS-1 alone with CDDP+TS-1 as postoperative adjuvant chemotherapy in non-small-cell-lung-cancer ; translational research of the chemotherapy effect prediction factor - WJOG4107

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001658

Enrollment

200

Registered

2009-01-26

Start date

2007-09-01

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

TS-1 CDDP,TS-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically confirmed Non Small Cell Lung Cancer 2)pStage II, IIIA (N2 Case is single station) 3)Case in which chemotherapy enforcement less than 8weeks after the operation is possible 4)Without prior chemotherapy nor use of chemotherapy, RT 5)Oral intake is possible 6)20<=,<75 years 7)Performance Status (ECOG) 0-1 8)Adequate organ functions 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1) clinically significant drug allergy 2) Under treatment with flucytosine, phenytoin, Warfarin Potassium, other trial drugs. 3) The infection which needs the medical treatment by antibiotics, and other serious complications 4) The case which has diarrhea continuously 5) The case which has clear interstitial pneumonia or a clear fibroid lung with a chest simple X ray 6) The case which has malignant tumors other than the lung cancer 7) The case which has the past of a malignant tumor 8) Not suitable for participating in the study for any other reason

Design outcomes

Primary

Measure	Time frame
Relapse-free survival of 2 years, to searches for the chemotherapy effect prediction factor.	—

Secondary

Measure	Time frame
Overall survival (OS), Rate of adverse events, Relative dose intensity, to searches for a prognosis prediction factor.	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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