CompletedPhase 2

Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

France105 participantsStarted 2021-02-04

Plain-language summary

The objective of this study is to evaluate the efficacity of the combination of cisplatin-5-FU and docetaxel in adapted doses in term of response to treatment without toxicity .

Who can participate

Age range18 Years – 74 Years

SexALL

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Inclusion criteria

✓. Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx, lymphadenopathy without front door
✓. Inoperable tumor or tumor whose surgery would be multilating.
✓. Patient not previously treated for ORL cancer
✓. Age \> 18 and \< 75 years
✓. PS 0 or 1 according to WHO
✓. At least one lesion measurable according to the RECIST 1.1 criteria
✓. Patient who can receive TPF according to the following criteria:
✓. Estimated life expectancy greater than or equal to 3 months

Exclusion criteria

✕. Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma
✕. Vaccination against recent or planned yellow fever
✕. Known deficiency in dihydropyrimidine dehydrogenase (DPD) or determined by the determination of uricemia.
✕. History of other cancer except in situ cervical cancer or controlled basal cell carcinoma. Patients in remission from cancer treated more than 3 years ago are eligible. Patients treated by surgery alone for ORL cancer in the previous 3 years are eligible.
✕. Previous treatment of an ORL cancer by chemotherapy or radiotherapy. Patients treated by surgery alone for ORL cancer in the previous 3 years are eligible).
✕. Presence of distant metastasis.
✕. Participation in a therapeutic trial in the 30 days preceding randomization
✕. Concomitant anticancer treatment

What they're measuring

Efficacity of combination of TPFm

Timeframe: 8 weeks after the end of treatment

Trial details

NCT IDNCT04356170

SponsorGroupe Oncologie Radiotherapie Tete et Cou

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-05

View on ClinicalTrials.gov More Cancer of Head and Neck trials