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Sponsors and Collaborators: |
AZ-VUB Sanofi-Aventis |
---|---|
Information provided by: | AZ-VUB |
ClinicalTrials.gov Identifier: | NCT00379717 |
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 | Intervention | Phase |
---|---|---|
Non-Small-Cell Lung Carcinoma |
Drug: Cisplatinum Drug: Docetaxel Device: Tomotherapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 30 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | April 2008 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory requirements at entry:
• Blood cell counts: i. Absolute neutrophils ≥ 2.0 x 109/L ii. Platelets ≥ 100 x 109/L iii. Haemoglobin ≥ 11 g/dl
• Renal function: i. Serum creatinine < 1 x the upper limit of normal (UNL). ii. In case of borderline value of serum creatinine, the 24h creatinine clearance should be > 60 ml/min.
• Hepatic function: i. Serum bilirubin < 1 x UNL ii. ASAT and ALAT < 2.5 x UNL iii. alkaline phosphatase < 5 x UNL iv. Patient with ASAT and/or ALAT > 1.5 x UNL associated with alkaline phosphatase> 2.5 x UNL is not eligible for the study.
Lung function tests at entry:
Exclusion Criteria:
Contact: Samuel Bral, MD | 003224776415 | samuel.bral@uzbrussel.be |
Contact: Nicolas Fontaine, Mr | 0032 2 477 54 61 | nicolas.fontaine@uzbrussel.be |
Belgium | |
UZ Brussel | Recruiting |
Jette, Belgium, 1090 | |
Contact: Samuel Bral, MD 0032 2 477 64 15 samuel.bral@uzbrussel.be | |
Contact: Nicolas Fontaine, Mr 0032 2 477 54 61 nicolas.fontaine@uzbrussel.be |
Principal Investigator: | Samuel Bral, MD | AZ-VUB |
Responsible Party: | UZ Brussel ( Bral Samuel ) |
Study ID Numbers: | VUB06-001, TomoCT |
Study First Received: | September 21, 2006 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00379717 |
Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
helical tomotherapy dose escalation chemotherapy |
Docetaxel Thoracic Neoplasms Non-small cell lung cancer Cisplatin Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type Radiation-Sensitizing Agents |
Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Pharmacologic Actions |