MedDRA version: 18.1 Level: LLT Classification code 10025044 Term: Lung cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Cisplatin
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: Cisplatin
Other descriptive name: CISPLATIN
Concentration unit: mg/ml milligram(s)/m
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed non-small cell lung cancer, including squamous cell carcinomas, adenocarcinomas and non-neuroendocrine large cell carcinomas • Patients with advanced stages of NSCLC who are candidates to first-line platinum-based doublet chemotherapy • Measurable disease by RECIST 1.1 • Age = 18 years. • Performance status 0-2. • Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion): - WBC = 3.0 * 10^9/l or neutrophils (ANC) = 1.5 * 10^9/l - Platelet count = 100 * 10^9/l - Hemoglobin = 6 mmol/l - Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 114
Exclusion criteria
Exclusion criteria: • Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence. • Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation. • Patients who have received prior chemotherapy for NSCLC • Patients with NSCLC who are candidates to neoadjuvant chemotherapy or curative chemoradiotherapy • Underlying disease not adequately treated (diabetes, cardiac disease) • Allergy to the active substance or any of the auxiliary agents • Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory. • Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to investigate the effect of tocotrienol as a nutritional supplement in combination with first-line chemotherapy on progression free survival (PFS) in patients with advanced NSCLC;Secondary Objective: • To investigate quality of life during treatment • To investigate the potential toxicity of the treatment • To investigaet the response rate • To investigate overall survival;Primary end point(s): Progression free survival ;Timepoint(s) of evaluation of this end point: After two treatment cycles and then every 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Quality of life 2 Safety and feasibility 3 Response rate 4 Overall survival;Timepoint(s) of evaluation of this end point: 1. After 2 treatment cycles and then every 3 months 2. Every three weeks during treatment 3. After 2 treatment cycles and then every 3 months 4. Every 6 months for 30 months | — |
Countries
Denmark
Contacts
Public ContactClinical Trial Unit
Vejle Hospital
Outcome results
None listed