Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00379717|
Recruitment Status : Unknown
Verified September 2006 by AZ-VUB.
Recruitment status was: Recruiting
First Posted : September 22, 2006
Last Update Posted : March 13, 2008
This non-randomized Phase I/II study is designed to determine the maximum tolerated dose (MTD) of thoracic radiotherapy and concurrent chemotherapy with cisplatin and docetaxel in patients with LA-NSCLC. All patients will receive weekly administrations of docetaxel 20 mg/m² and cisplatin 20 mg/m2 concurrently with radiotherapy. Radiotherapy will be delivered using helical tomotherapy in 30 daily fractions over six weeks. Patients should have recovered fully from induction concurrent chemoradiotherapy before they continue with the consolidation chemotherapy phase. Patients will be entered in cohorts of at least 5 subjects.
The first cohort of patients will receive 30 fractions of 2Gy in six weeks up to a total dose of 60Gy. The concurrent chemotherapy starts at day 1 of the radiotherapy and will be administered 2-4 hours before the radiotherapy.
The radiotherapy fraction size will be escalated to 2.36Gy in three steps.
|Condition or disease||Intervention/treatment||Phase|
|Non-Small-Cell Lung Carcinoma||Drug: Cisplatinum Drug: Docetaxel Device: Tomotherapy||Phase 1 Phase 2|
Dose escalation steps are:
30*2.00Gy = 60.0Gy (BED= 70.8Gy10 NID2= 60.0Gy) 30*2.12Gy = 63.6Gy (BED= 75.9Gy10 NID2= 64.2Gy) 30*2.24Gy = 67.2Gy (BED= 81.5Gy10 NID2= 68.5Gy) 30*2.36Gy = 70.8Gy (BED= 86.3Gy10 NID2= 72.9Gy) If MTD is not reached, protocol modification allowing further escalation can be considered.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Concurrent Helical Tomotherapy With Chemotherapy in Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC): a Phase I/II Trial of Radiation Dose Escalation and Fixed Dose Chemotherapy.|
|Study Start Date :||November 2006|
|Study Completion Date :||April 2008|
- To evaluate the feasibility and toxicity of radiation dose escalation using helical tomotherapy concurrently with chemotherapy (docetaxel-cisplatin combination) in stage III locally advanced non small cell lung cancer (LA-NSCLC).
- To estimate efficacy parameters in terms of overall response rate, progression free survival and overall survival. To monitor quality of life (QOL) before, during and after treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379717
|Contact: Samuel Bral, MDfirstname.lastname@example.org|
|Contact: Nicolas Fontaine, Mr||0032 2 477 54 email@example.com|
|Jette, Belgium, 1090|
|Contact: Samuel Bral, MD 0032 2 477 64 15 firstname.lastname@example.org|
|Contact: Nicolas Fontaine, Mr 0032 2 477 54 61 email@example.com|
|Principal Investigator:||Samuel Bral, MD||AZ-VUB|