Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer

Randomized phase II trial of Carboplatin/Gemcitabine versus Cisplatin/Gemcitabine for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer - Randomized phase II trial of CBDCA/GEM versus CDDP/GEM for the patient with completely resected pathological stage IB-IIIA of Non Small Cell Lung Cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000913

Enrollment

102

Registered

2007-11-29

Start date

2007-11-01

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

Non Small Cell Lung Cancer

Interventions

adjuvant chemotherapy with CDDP+GEM adjuvant chemotherapy with CBDCA+GEM

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. pathologically proven non-small cell lung cancer 2. complete resection 3. pathological stage IB, II, and stage IIIA 4. no prior anti cancer treatment for thoracic malignancy except for this operation 5. Performance status(ECOG)0-1 6. adequate organ function for chemotherapy 7. written informed consent

Exclusion criteria

Exclusion criteria: 1. sever infection 2. uncontrolled Diabetes Mellitus and hypertension, unstable angina or Myocardial Infarction within 6 months 3. apparent interstitial pneumonitis at chest rentogenogram 4. Uncontrollable pleural effusion 5. multiple lung cancer or other-type cancer within 5 years 6. History of severe hypersensitivity 7. Pregnant or expecting woman

Design outcomes

Primary

Measure	Time frame
2-year relapse free survival	—

Secondary

Measure	Time frame
Safety Feasibility Overall survival time	—

Countries

Japan

Contacts

Public ContactShin-ichi Fukumoto

Hokkaido Lung Cancer Clinical Study Group Department of Pulmonary Disease, National Hospital Organization Hokkaido Cancer Center

fukumoto.shinichi.ad@mail.hosp.go.jp011-811-9111

Outcome results

None listed

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