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: Drug: DOCETAXEL; Radiation: Intensity Modulated Radiotherapy (IMRT); Drug: CISPLATIN

• 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.

Study Timeline

• Study First Submitted: 2010-12-23
• Study First Submitted QC: 2010-12-23
• Study First Posted: 2010-12-24
• Study Start: 2011-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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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

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇭🇰 Hong Kong, Hong Kong