Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer
Phase 2
Completed
- Conditions
- Lung Neoplasms
- Interventions
- Registration Number
- NCT01266512
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description IMRT & docetaxel-cisplatin Intensity Modulated Radiotherapy (IMRT) 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 IMRT & docetaxel-cisplatin DOCETAXEL 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 IMRT & docetaxel-cisplatin 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
- Primary Outcome Measures
Name Time Method Response rate (by contrast CT scan) 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
- Secondary Outcome Measures
Name Time Method 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie IMRT and docetaxel-cisplatin synergy in inoperable stage III NSCLC?
How does IMRT with SPECT-CT/PET guidance compare to conventional chemoradiotherapy in stage III NSCLC outcomes?
Which biomarkers correlate with progression-free survival in NCT01266512 chemoradiotherapy trial?
What are the most common adverse events associated with concurrent IMRT and platinum-based chemotherapy in NSCLC?
Are there alternative platinum-based chemotherapeutic combinations to docetaxel-cisplatin for IMRT in stage III NSCLC?
Trial Locations
- Locations (1)
Sanofi-Aventis Administrative Office
🇭🇰Hong Kong, Hong Kong
Sanofi-Aventis Administrative Office🇭🇰Hong Kong, Hong Kong