A randomised controlled dose intensification clinical trial of chemotherapy with or without recombinant human granulocyte colony stimulating factor (G-CSF) in small cell lung cancer (SCLC)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15921116

Enrollment

400

Registered

2001-03-13

Start date

1993-12-01

Completion date

Unknown

Last updated

2017-10-09

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

Conditions

Lung cancer Cancer Small cell lung cancer (SCLC)

Interventions

The trial is designed to determine whether dose intensification with G-CSF is associated with a significant improvement in outcome compared with SCLC patients not receiving G-CSF. Patients with limite

Eligibility

Inclusion criteria

Inclusion criteria: 1. Untreated, microscopically proven SCLC 2. World Health Organisation (WHO) performance status 0-2 3. Alkaline phosphatase (AP) and Alanine amino transferase (ALT) less than or equal to 2.5 x upper normal limit and serum creatine/urea less than or equal to 1.25 x upper normal limit 4. Not receiving any other investigational drugs 5. Female patients must not be pregnant

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
Principle end-point is survival from randomisation	—

Secondary

Measure	Time frame
Secondary end-points are: 1. Interval between cycles of chemotherapy 2. Clinical septicaemic myelosuppression 3. WHO grade 3 or 4 neutropenia (less than 1000/mm3 cubed) 2 weeks after the first 3 cycles of chemotherapy 4. Quality of life 5. Days spent in hospital	—

Countries

United Kingdom

Outcome results

None listed

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