NCT01266512

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 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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Neoplasms

Interventions

Type	Name	Description
DRUG	DOCETAXEL	Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous
RADIATION	Intensity Modulated Radiotherapy (IMRT)	2 Gy per fraction
DRUG	CISPLATIN	Pharmaceutical form: solution for infusion Route of administration: intravenous

Timeline

• Start date: 2011-01-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-12-24
• Last updated: 2014-07-16

Locations

1 site across 1 country: Hong Kong