Non Small Cell Lung Carcinoma Clinical Trial
Official title:
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer
The study compares 2 different methods of combined chemotherapy and radiotherapy for the
treatment of localised lung cancer in patients not suitable for surgery.
Hypothesis(es) to be tested:
1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine
+ high dose palliative radiotherapy in terms of efficacy in a multi-institutional
setting
2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine
+ high dose palliative radiotherapy in terms of feasibility in a multi-institutional
setting
3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity
profile relative to gemcitabine + high-dose palliative radiotherapy
A third of patients with non-small cell lung cancer (NSCLC) present with Stage IIIA or IIIB
disease, which is not amenable to curative resection. Single modality local therapy, either
surgery or radiation, only cures a fraction of such patients.
Radical radiation is not feasible for all patients with unresectable Stage IIIA or IIIB
non-small cell lung cancer, based upon the extent of the loco-regional disease or the
medical state of the patient. Patients of good performance status receiving protracted
high-dose palliative radiotherapy do obtain a survival benefit from this therapy. Studies
have shown a survival advantage by adding chemotherapy to radical radiation therapy: but
studies in the high-dose palliative radiotherapy setting are lacking. Two regimens of
concurrent chemotherapy with high-dose palliative radiotherapy have been developed locally,
with established MTDs. These 2 regimens do warrant a comparative assessment in a phase II
trial, prior to a phase III trial against high dose palliative radiation alone (36Gy/12#/5).
This is a randomised phase II trial comprising of 2 arms for randomization as follows:
Arm A:External beam radiation, 40 Gy/20#/5 per week, Plus concurrent Vinorelbine, IV,
25mg/m2, days 1, 8, 22 and + Cisplatin 20mg/m2, IV, weekly
Arm B:External beam radiation, 30 Gy/15#/5 per week, Plus concurrentGemcitabine, 200mg (flat
dose) IV days 1, 8, 15
An equal number of patients will be randomised to each arm. The randomisation will be
carried out by the Princess Alexandra Trial Centre.
Patients will be assessed at baseline, weekly during treatment, and then at 3 weeks, 6 weeks
and 12 weeks post treatment then 3 monthly thereafter.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT01229150 -
Randomized Phase II Study of AZD6244 (Mitogen-activated Protein Kinase Inhibitor) MEK-Inhibitor With Erlotinib in KRAS Wild Type Advanced Non-Small Cell Lung Cancer (NSCLC) and a Randomized Phase II Study of AZD6244 With Erlotinib in Mutant KRAS Adva...
|
Phase 2 | |
Terminated |
NCT00592007 -
Study Evaluating the Addition of Fulvestrant to Erlotinib in Stage IIIB/IV Non-Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT00199758 -
Study of an Early Change of a Chemotherapeutic Doublet Versus Four Cycles of Chemotherapy in Advanced Non Small Cell Lung Cancer
|
Phase 2 | |
Completed |
NCT01999738 -
Folic Acid-Tubulysin Conjugate EC1456 In Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT01941316 -
Study of Carfilzomib With Irinotecan in Irinotecan-Sensitive Malignancies and Small Cell Lung Cancer Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00111839 -
Effects of Matuzumab in Combination With Pemetrexed for the Treatment of Advanced Lung Cancer
|
Phase 2 | |
Completed |
NCT00181532 -
Phase II Study of Celecoxib and Concurrent Radiotherapy in Stage II-III NSCLC
|
Phase 2 | |
Completed |
NCT00890903 -
Non-Interventional Study With Vinorelbine ORAL in Advanced Non-Small Cell Lung Carcinoma(NSCLC) and Metastatic Breast Cancer (MBC)
|
N/A | |
Completed |
NCT00864266 -
Biological Factors Predicting Response to Chemotherapy in Advanced Non Small Cell Lung Cancer
|
N/A | |
Completed |
NCT00635791 -
Phase I Study of Vorinostat and Sorafenib in Advanced Cancer
|
Phase 1 | |
Recruiting |
NCT00727350 -
Protocol for Primary Fractionated Stereotactic Body Radiation Therapy for Stage T1 - T3N0 Non Small Cell Lung Carcinoma.
|
Phase 2 | |
Completed |
NCT01209520 -
Residual Hypermethylation in Early Stage Non-Small Cell Lung Cancer (NSCLC) As Part of Adjuvant Therapy and Preventive Strategy
|
N/A | |
Active, not recruiting |
NCT00759382 -
Prognostic Role of Primary Non Small Cell Lung Carcinoma Standardized F18-FDG Uptake Values (SUV and TLG) Measured With F18-fluorodeoxyglucose Positron Emission Tomography (F18-FDG-PET): a Non Interventional Study.
|
||
Completed |
NCT00087711 -
A Randomized Phase 3 Trial of Pemetrexed and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
|
Phase 3 | |
Completed |
NCT00252798 -
ZD1839 (Iressaâ„¢) and Concurrent Chemo-Radiation in Patients With Locally Advanced Non Small Cell Lung Cancer
|
Phase 1 | |
Completed |
NCT02938624 -
Anti PD-1 Neo-adjuvant Treatment for NSCLC
|
Phase 1 | |
Completed |
NCT00608868 -
SELINE: Second-Line Iressa Phase IV Study in NSCLC Patients
|
Phase 4 | |
Terminated |
NCT00661011 -
Lobectomy and Mediastinal Radiochemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer Responding to Induction Chemotherapy
|
Phase 2 | |
Terminated |
NCT00234468 -
Iressa vs Placebo as Maintenance Therapy in Locally Advanced NSCLC
|
Phase 3 | |
Completed |
NCT00252746 -
ZD6474 Phase IIa Dose Finding Multicentre Study
|
Phase 2 |