Non Small Cell Lung Cancer Clinical Trial
— IscadorOfficial 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
Verified date | September 2011 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | May 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 (CT) 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus | Weleda AG |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality Of Life | To check the effect of the treatment(or lack of it) on the quality of life of the patients enrolled to the trial. | During the trial | No |
Primary | Improvement in QOL. Improvement in the toxicity profile of the chemotherapy treatment | To check on the difference in QoL of all patients. | During all the trial | Yes |
Secondary | Objective Response | The patients are asked to answer questions and the doctor will check blood works resolts. | During all the duration of the trial | No |
Secondary | Improvement in time to tumor progression (TTP) and survival Safety profile of mistletoe extract with combination of chemotherapy treatment | Looking out for difference in toxicity profile of all patients | During duration of all the trial | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 |