A Phase III randomised comparison of Gemcitabine/Carboplatin with Mitomycin, Ifosfamide and Cisplatin in non-small cell lung cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52253218

Enrollment

Unknown

Registered

2002-08-19

Start date

1995-01-01

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 (non-small cell) cancer Cancer Malignant neoplasm of bronchus and lung

Interventions

1. GC Arm: 3-weekly regimen. Gemcitabine 1200 mg/m2 IV (Day 1 and 8) Carboplatin (AUC 5). Dose calculated according to the formula: Dose = Target area under curve x (creatinine clearance + 25) IV (Day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically proven non-small cell carcinoma of the lung 2. Stage IIIb or IV disease 3. Measurable or evaluable disease 4. Adequate renal function (Ethylene diamine tetraacetic acid [EDTA] Clearance >60 ml/min) 5. Age 18 or over 6. Adequate contraception in females of child-bearing potential 7. Written informed consent 8. No prior radiotherapy or chemotherapy 9. Not less than 8 weeks life expectancy 10. No history of prior malignancy (except non-melanomatous skin tumour or has been without evidence of disease for 3 years or more) 11. White cell count >3000/ml Platelet count >100,000/ml Haemaglobin >10.0 g.dL 12. No symptomatic brain metastases

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Not provided at time of registration	—

Secondary

Measure	Time 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