Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).
Sponsor study identifier
interventional
439
2 countries
2
Study Start
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Primary Objective:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2010
Actual (reported)Click 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.
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
December 2, 2005
Actual (reported)December 5, 2005
Actual (reported)July 2010
Actual (reported)July 2010
Actual (reported)Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C).
16 weeks
Phase III: Surveillance with no progression after two years.
2 years
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
Cisplatin + Radiotherapy
Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)
Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
Cisplatin, 5-fluorouracil (5-FU), 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
Cisplatin + radiotherapy
The registry names a treatment alongside a procedure. This entry does not establish their timing or actual administration.
View registry recordSanofi-Aventis
Porto Salvo, Portugal
Sanofi-Aventis
Barcelona, Spain
Hitt R, Iglesias L, Lopez-Pousa A, Berrocal-Jaime A, Grau JJ, Garcia-Giron C, Martinez-Trufero J, Guix M, Lambea-Sorrosal J, Del Barco-Morillo E, Leon-Vintro X, Cunquero-Tomas AJ, Baste N, Ocana A, Cruz-Hernandez JJ; the Spanish Head and Neck Cancer Cooperative Group (TTCC). Long-term outcomes of induction chemotherapy followed by chemoradiotherapy vs chemoradiotherapy alone as treatment of unresectable head and neck cancer: follow-up of the Spanish Head and Neck Cancer Group (TTCC) 2503 Trial. Clin Transl Oncol. 2021 Apr;23(4):764-772. doi: 10.1007/s12094-020-02467-8. Epub 2020 Aug 14.
Hitt R, Grau JJ, Lopez-Pousa A, Berrocal A, Garcia-Giron C, Irigoyen A, Sastre J, Martinez-Trufero J, Brandariz Castelo JA, Verger E, Cruz-Hernandez JJ; Spanish Head and Neck Cancer Cooperative Group (TTCC). A randomized phase III trial comparing induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as treatment of unresectable head and neck cancer. Ann Oncol. 2014 Jan;25(1):216-25. doi: 10.1093/annonc/mdt461. Epub 2013 Nov 19.
JOSÉ Mª TABOADA
Sanofi
439 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2005
First Posted
December 5, 2005
Study Start
December 2002
Date type not reportedThis date has not been verified as actual or estimated.
Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
July 2010
Actual (reported)Study Completion
July 2010
Actual (reported)Last Updated
May 11, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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