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A Phase III Randomised comparison of Gemcitabine/Carboplatin with Cisplatin/Etoposide in Small Cell Lung Cancer

A Phase III Randomised comparison of Gemcitabine/Carboplatin with Cisplatin/Etoposide in Small Cell Lung Cancer

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN39679215
Enrollment
Unknown
Registered
2002-08-19
Start date
1996-01-01
Completion date
Unknown
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung (small cell) cancer Cancer Lung (small cell)

Interventions

1. GC Arm: 3-weekly regimen (6 cycles) Gemcitabine 1200 mg/m(2) IV (Day 1 and 8) Carboplatin (AUC 5) Dose in mg calculated according to the formula: Dose = Target area under curve x (creatinine cleara

Sponsors

NCRI CSG and London Lung Cancer Group (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically proven small cell anaplastic carcinoma of the lung 2. Extensive stage disease or limited stage but locally advanced or limited stage with poor prognostic factors 3. Measurable or evaluable disease 4. Adequate renal function for chemotherapy 5. Age 18 years or above 6. Adequate contraception for women of child bearing potential 7. Written informed consent

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026