Randomized Phase II Trial of Neoadjuvant Docetaxel Plus Cisplatin and 5-fluorouracil Followed by Concomitant Chemoradiotherapy and Chemoradiotherapy Alone in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck.
Sponsor study identifier
interventional
101
1 country
1
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2008
Actual (reported)Study Completion
Not reported
Date not reportedTo evaluate the rate of clinical complete response 6-8 weeks after treatment with docetaxel plus cisplatin and 5-fluorouracil followed by chemoradiotherapy and after chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
July 26, 2006
Actual (reported)July 27, 2006
Actual (reported)February 2008
Actual (reported)Rate of radiologic Complete Response (CR) evaluated 6-8 weeks after the completion of treatment
from end of treatment until 6-8 weeks
Duration of response
from the date of first documented tumor response to the date of first documented tumor progression
Time to disease progression
From the date of the treatment start to the date of first documented progression of disease
Time to treatment failure
from the date of treatment start to the date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death for any cause
Median length of overall survival
time interval from the date of treatment to the date of death
Cisplatin from day 1 to day 4 and 5-FU for 4 days starting immediately after the end of cisplatin infusion on day 1. Both drugs were administered during week 1 and 6 of irradiation, starting from day 1 of weekly radiotherapy.
Docetaxel followed by cisplatin and 5-FU from day 1 to day 4 starting after the end of cisplatin infusion. The cycle was repeated every 3 weeks up to a total of 3 cycles. After 3-6 weeks from the end of neoadjuvant chemotherapy, patients will receive with the same modality of arm A (reference arm).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTreatment and procedure
Concomitant cisplatin, 5-FU and radiotherapy
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordSanofi-Aventis
Milan, Italy
Georges Paizis, MD
Sanofi
101 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2006
First Posted
July 27, 2006
Study Start
January 2003
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
February 2008
Actual (reported)Last Updated
December 7, 2009
Record last verified: 2009-12
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Source: ClinicalTrials.gov.
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