New chemo cocktail aims to tame aggressive head and neck tumors with fewer side effects
NCT ID NCT04356170
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase II trial tested a combination of three chemotherapy drugs (cisplatin, 5-fluorouracil, and docetaxel) at adapted doses in 105 patients with locally advanced head and neck cancer that could not be surgically removed. The goal was to see if this adjusted dosing could effectively shrink tumors while reducing severe toxicity. The study measured how many patients had a successful response at 8 weeks without serious side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy combination (cisplatin, 5-fluorouracil, docetaxel)
- What this could lead to
- If successful, this could provide a more tolerable chemotherapy regimen for patients with inoperable head and neck cancer, potentially improving treatment response while reducing severe side effects.
- What could go wrong
- This is a phase II trial with only 105 participants and no comparison group, so results are preliminary. The chemotherapy combination still carries significant toxicity risks, and success in this early stage does not guarantee broader effectiveness.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
105 people
The number who actually took part.
- Started
-
Feb 2021
- Finished
-
Aug 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 74 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 7. Patient who can receive TPF according to the following criteria: * Adequate hematological function: neutrophils ³ 1.5 x 109 / l, platelets \*100 x 109 / l, hemoglobin 10 g / dl (or 6.2 mmol / l) * Adequate renal function: calculated creatinine clearance (Cockroft \& Gault) or measured ³ 60 ml / min. * Adequate liver function: normal total bilirubin; ASAT and ALAT less than or equal to 1.5 ´ LNS; PAL less than or equal to 2.5 X LNS * Grade \<2 peripheral neuropathy according to NCI CTCAE v5.0 * No clinical impairment of hearing function * For patients aged 71 to 74, PS at 0 and considered non-geriatrically fragile (G8 questionnaire and multidimensional assessments proposed by the GERICO group (ADL, MMSE, GDS scale, nutrition, motor skills and balance, geographic and personal situation and assessments) thymic)) 8. Estimated life expectancy greater than or equal to 3 months 9. Weight loss of less than 10% during the 3 months before randomization 10. Patient understanding French and able to complete quality of life questionnaires 11. Patient having given written consent before any specific protocol procedure 12. Affiliation to a social security scheme or beneficiary of such a scheme 13. Women of childbearing potential and sexually active men agreeing to use effective contraceptive methods for the duration of treatment and at least 6 months after the last administration of study treatments 14. Patient agrees not to donate sperm for the duration of the treatment and at least 6 months after the last administration of the study treatments 15. Absence of deficiency in dihydropyrimidine dehydrogenase activity determined by uracilemia assay (Uracilemia \< 16 ng/mL) 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): * Uncontrolled cardiac pathology despite adequate treatment * Myocardial infarction in the 6 months preceding randomization * Neurological or psychiatric history such as dementia, convulsions * Active infection * Significant gastrointestinal abnormalities, including those that require parenteral nutrition, active peptic ulcer, and history of surgeries affecting absorption * Obstructive pulmonary disease requiring hospitalization in the year preceding randomization * Uncontrolled type II diabetes or other corticosteroid contraindications. * Moderate or severe eczema 11. Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients. 12. Intended concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin 13. Presence, upon selection, of psychological, family, social or geographic factors likely to influence the patient's compliance with the study and monitoring protocol. 14. Pregnant or lactating woman 15. Patient (male or female) of reproductive age who is unable or unwilling to take adequate contraceptive measures during treatment and up to 6 months after the last treatment is administered. 16. Persons deprived of their liberty, under guardianship or curatorship
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cancer of head and neck are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Centre Leon Berard
Lyon, 69008, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New imaging technique could help doctors predict cancer treatment response
- Can less radiation be safer without sacrificing cancer control?
- New study aims to help cancer survivors manage other health problems
- Cialis and keytruda together against head and neck cancer: small trial shows promise?
- New program aims to ease the burden of head and neck cancer treatment
- Immunotherapy combo shows promise in reducing head and neck cancer recurrence