EUCTR2015-002742-32-DK
Active, not recruiting
Phase 1
Tocotrienol as a nutritional supplement in patients with advanced pulmonal cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 18.1Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864
- Sponsor
- Vejle Hospital
- Enrollment
- 190
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \< 2\.0 \* ULN
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.
Outcomes
Primary Outcomes
Not specified
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