Non-small cell lung cancer Small-cell lung cancer Malignant Mesothelioma (ICD classification code:C45.9)
Conditions
Interventions
Product Name: Folic Acid
Pharmaceutical Form: Tablet
Product Name: Gemcitabine
Pharmaceutical Form: Intravenous infusion
Product Name
Sponsors
Royal Marsden Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Male or female, age>18 yrs 3. Histologically or cytologically confirmed NSCLC, SCLC or mesothelioma, where giving cisplatin 75mg/m2 or carboplatin (AUC 5 or 6) is appropriate. 4. ECOG: PS 0-2 5. Lab requirements at entry: serum creatinine =1.25 ULN, creatinine clearance> 50mls/min (EDTA) or > 60mls/min (C+G) WBC > 3 x 10 9/l, neutrophils >1.5 x 10 9/l, platelets > 100 x 10 9/l, 6. Effective contraception if indicated 7. Estimated life expectancy of at least 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. Active infection 3. Inability or unwillingness to take vitamin supplementation 4. Serious systemic disorders incompatible with the study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether the addition of vitamin supplementation to the platinum-based chemotherapy regime impacts on the toxicity of the treatment compared to platinum-based chemotherapy alone. The main outcome measures are the incidence of neutropenia, mucositis and emesis.; Secondary Objective: 1.To compare survival. 2. To retrospectively compare outcome and toxicity with our previous experience with platinum-based regimes using a cisplatin dose of 50mg/m2 3.Pre-treatment samples for total plasma homocysteine levels will also be taken and stored for later analysis should a difference in neutropenia be detected between the two groups. 4.DNA will be stored for genetic studies at a later point if appropriate. 5. To compare quality of life ; Primary end point(s): The primary end points include: Incidence of neutropenia Incidence of mucositis Incidence of emesis Overall survival Quality of life | — |
Countries
United Kingdom
Outcome results
None listed