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Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination: Randomized Phase II Study

Phase 2
18 Years
Not Enrolling
Non Small Cell Lung Cancer

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Trial Information

Mistletoe as Complementary Treatment in Patients With Advanced Non-small-cell Lung Cancer (NSCLC), Treated With Carboplatin/Gemcitabine Chemotherapy Combination: Randomized Phase II Study

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.

Inclusion Criteria:

1. Age above 18 years

2. Histology proven of NSCLC

3. Stage IIIB or IV (TNM classification)

4. Performance status < 2 (ECOG classification

5. Measurable disease with one or more disease sites measured by computed tomography

6. Life expectancy of more than 12 weeks.

7. Treatment combination of gemcitabine/carboplatin (GC)

8. Sign of written informed consent -

Exclusion Criteria:

1. Prior chemotherapy

2. Prior radiation- allowed as long as the treatment was not targeted only site of
measurable disease and given more than 3 weeks before entry the trial.

3. Central nervous system metastases

4. Hypercalcemia

5. Other life threatening medical conditions

6. Patients not able to comply with s.c. injections

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Quality Of Life

Outcome Description:

To check the effect of the treatment(or lack of it) on the quality of life of the patients enrolled to the trial.

Outcome Time Frame:

During the trial

Safety Issue:


Principal Investigator

Gil Bar-Sela

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rambam Health Care Campus


Israel: Ministry of Health

Study ID:




Start Date:

April 2007

Completion Date:

May 2011

Related Keywords:

  • Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms