A Phase 2 interventional study of DOCETAXEL and Intensity Modulated Radiotherapy (IMRT) in Lung Neoplasms, sponsored by Sanofi. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.
Sponsored by Sanofi · Phase 2, Interventional, and Treatment
Primary Objective:
Secondary Objectives:
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 34 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Drug: DOCETAXEL · Radiation: Intensity Modulated Radiotherapy (IMRT) · Drug: CISPLATIN
Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous
2 Gy per fraction
Pharmaceutical form: solution for infusion Route of administration: intravenous
Response rate (by contrast CT scan)
Time frame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Progression Free survival (PFS)
Time frame: Day 1 of treatment to the date of objective disease progression
Overall survival (OS)
Time frame: Day 1 of treatment to the date of death due to any cause
Adverse events (including oesophageal and pulmonary toxicities)
Time frame: Informed consent signature up to 12 weeks after completion of treatment
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sanofi