Non Small Cell Lung Cancer Clinical Trial
Official title:
Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination: Randomized Phase II Study
Mistletoe extract is one of the most common complementary treatments used in Europe. Recent
basic studies reported tumor response and survival prolongation in number of treatments with
Mistletoe preparations. There are evidence based data for using this drug as side effect
reducer when use in combination with chemotherapy regimen treatment. Other clinical data,
although not well based is that complementary treatment when used in combination with the
common oncology treatment has tumor response effect. Combinations with platinum compound and
a third generation cytotoxic agent have been accepted as 'standard of care' for patients
with advanced NSCLC. The combination of platinum compound and one of the new agents are
associated with response rates of 30-40% and a median survival of 8-11 months for advanced
NSCLC patients with good performance status.
Study objective: Improvement in QOL, Improvement in the toxicity profile of the chemotherapy
treatment.
The study design is to include 90 subjects. All subjects are treated with the common
chemotherapy treatment. 50 percent will be treated with Iscador as combination with their
common chemotherapy regimen. Common chemotherapy regimen used for NSCLC: Carboplatin and
Gemcitabine. All study participants will receive this same chemotherapy regimen. This
chemotherapy treatment is given every 3 weeks for up to 6 treatment cycles. The first day of
the first treatment cycle, the combination of both Carboplatin and Gemcitabine will be
administered. After a week (day 8 of treatment cycle) only Gemcitabine will be administered.
Drugs would be calculated according to patient's body mass, renal function and general
appearance. Once the patient signed Informed Consent he is assigned randomly to be treated
with/without the injections of Mistletoe (called "Iscador"). Patient will receive the study
medication (Iscador) as an intravenous injection that can be self injected or injected by
any other of the family. Injections would be administered with low dose at the first week of
the first treatment cycle and then, dose would be escalated, so as to check high sensitivity
to the drug. Dosage would include: 2 injections of 0.1 mg, 2 injections of 0.1 mg and 2
injections of 1 mg. After that, treatment would continue with dosage of 10 g once every 2
days.
Patients from both treatment arms would be asked to fill-out QOL questionnaires at every
treatment cycle and at follow-up visit after.
Study Primary Objectives:
1. Improvement in QOL
2. Improvement in the toxicity profile of the chemotherapy treatment
Secondary Objectives:
1. Improvement in time to tumor progression (TTP) and survival.
2. Safety profile of mistletoe extract with combination of chemotherapy treatment
This is a single center study, randomized phase II, with patients with advanced NSCLC
treated with carboplatin/gemcitabine chemotherapy combination.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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