Loading clinical trials...

Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

A Phase II Randomized Trial, Non Comparative, Evaluating Chemotherapy Associated Cisplatin, 5-fluorouracil and Docetaxel at Adapted Doses in Patients With Locally Advanced Squamous Cell Carcinoma

NCT04356170•Groupe Oncologie Radiotherapie Tete et Cou

View on ClinicalTrials.gov

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 .

Detailed Description

After explaining the treatment modalities, having read and explained the information letter to them, patients who have signed the consent to participate in the trial and who meet the inclusion criteria will be enrolled and randomized in the trial .

Eligibility

Age

18 - 74 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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
•2. Inoperable tumor or tumor whose surgery would be multilating.
•The non-operability criteria are:
•* Technically impossible resection: fixation / invasion of the tumor at the base of the skull or at the cervical vertebrae, nasopharynx involved, lymph nodes
•* Medical selection based on low surgical curability. This category includes all T3-T4 and all N2-N3 (AJCC 8th edition, June 2018)
•* Medical selection based on an organ preservation strategy
•3. Patient not previously treated for ORL cancer
•4. Age \> 18 and \< 75 years
•5. PS 0 or 1 according to WHO
•6. At least one lesion measurable according to the RECIST 1.1 criteria
+15 more criteria

Exclusion Criteria

•1. Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma
•2. Vaccination against recent or planned yellow fever
•3. Known deficiency in dihydropyrimidine dehydrogenase (DPD) or determined by the determination of uricemia.
•4. 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.
•5. 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).
•6. Presence of distant metastasis.
•7. Participation in a therapeutic trial in the 30 days preceding randomization
•8. Concomitant anticancer treatment
•9. Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg / day of methylprednisolone or equivalent
•10. Other existing serious medical pathologies (non-exhaustive list):
+14 more criteria

Locations (1)

Centre Leon Berard

Lyon, France

Key Dates

Start Date

February 4, 2021

Primary Completion Date

August 5, 2025

Completion Date

August 5, 2025

Last Updated

September 2, 2025

Enrollment

105

ACTUAL participants

Conditions

Cancer of Head and Neck

Interventions

Docetaxel

DRUG

Cisplatin

DRUG

Fluoro Uracil

DRUG

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

NCT02296684

Cancer of Head and NeckHead and Neck Cancer+4 more

View study

COMPLETEDNA

RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer

NCT04800419

Cancer of Head and Neck

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

Inclusion Criteria

Exclusion Criteria

Immunotherapy With MK-3475 in Surgically Resectable Head and Neck Squamous Cell Carcinoma

RCT of Effects of Mindfulness-based Stress Reduction in Head and Neck Cancer

Artificial Intelligence-based Voice Assessment of Children and Adults Respiratory Conditions

To Determine Safe and Effective Dose of Sotatercept for the Treatment of Chemotherapy Induced Anemia in Participants With Advanced Non-small Cell Lung Cancer

Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial

Postoperative Pain, Why Still in Hospital and DAOH Following TORS for SCCUP & OSAS