Phase II Study of Concurrent Chemoradiotherapy Using IMRT (With Single Photon Emission Computed Tomography/SPECT-CT to Define Functional Lung Volume and Positron Emission Tomography/PET to Define Gross Tumour Volume/GTV) and Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 2
- Intervention
- DOCETAXEL
- Conditions
- Lung Neoplasms
- Sponsor
- Sanofi
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Response rate (by contrast CT scan)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
Primary Objective:
- Response rate (by contrast CT scan)
Secondary Objectives:
- Progression-free survival (PFS)
- Overall survival (OS)
Detailed Description
The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
IMRT & docetaxel-cisplatin
Concurrent chemo-RT: Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks - Resting period: 2 weeks - Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 - Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration
Intervention: DOCETAXEL
IMRT & docetaxel-cisplatin
Concurrent chemo-RT: Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks - Resting period: 2 weeks - Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 - Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration
Intervention: Intensity Modulated Radiotherapy (IMRT)
IMRT & docetaxel-cisplatin
Concurrent chemo-RT: Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks - Resting period: 2 weeks - Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 - Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration
Intervention: CISPLATIN
Outcomes
Primary Outcomes
Response rate (by contrast CT scan)
Time Frame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Secondary Outcomes
- Progression Free survival (PFS)(Day 1 of treatment to the date of objective disease progression)
- Overall survival (OS)(Day 1 of treatment to the date of death due to any cause)
- Adverse events (including oesophageal and pulmonary toxicities)(Informed consent signature up to 12 weeks after completion of treatment)