Randomized Phase II trial of 1st-line biweekly Gemcitabine (G) and Carboplatin (C) vs biweekly Gemcitabine (G) and Carboplatin (C)plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)

Randomized Phase II trial of 1st-line biweekly Gemcitabine (G) and Carboplatin (C) vs biweekly Gemcitabine (G) and Carboplatin (C)plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC) - Randomized PhaseII trial of 1st-line biweekly Gemcitabine and Carboplatin plus maintenance Gemcitabine in elderly patient untreated non-small cell lung cancer (NSCLC)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004386

Enrollment

Registered

2010-10-14

Start date

2008-09-01

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

elderly patient untreated non-small cell lung cancer

Interventions

4 cycles of combined chemotherapy with gemcitabine 1000mg/m2 at day1, 15 and carboplatin AUC3 at day1, 15 followed by chemotherapy with gemcitabine 1000mg/m2 at day1, 15 until PD 4 cycles of combined

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Chemotherapy-naive patients with histologically or cytologically confirmed NSCLC 2)Measurable lesion according to the RECIST 3)Stage IIIB not amenable to curative treatment or stage IV 4)Over 70 years of age 5)PS0, 1 6)Apropriate organ function 7)Life expectancy over 3 months 8)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Overt infection 2)Febrile state (over 38 degree C) 3)Severe complicaiton including heart disease, pulmonary fibrosis, bleeding tendency, uncontrollable hypertension and diabetes mellitus 4)Double cancer 5)Symptomatic brain metastasis 6)Uncontrolled third-space fluid retention 7)Pericardial effusion 8)varicella virus infection 9)Peripheral neuropathy 10)Hypersensitivity drug reaction 11)Pregnant and nursing woman 12)Inappropriate to entry by physician

Design outcomes

Primary

Measure	Time frame
Progression free survival	—

Secondary

Measure	Time frame
Response rate, Quality of life, Adverse events, Overall survival	—

Countries

Japan

Contacts

Public ContactTaishi Harada

Kyushu University, Graduate School of Medical Sciences Research Institute for Diseases of the Chest

harada-t@kokyu.med.kyushu-u.ac.jp092-642-5378

Outcome results

None listed

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