Cancer of Head and NeckPhase 2TPFmORLNCT04356170
Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma
A Phase 2 study testing Docetaxel, Cisplatin and Fluoro Uracil in people with Cancer of Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Docetaxel, Cisplatin and Fluoro Uracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2021to 5 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
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- 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:
- 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))
- Estimated life expectancy greater than or equal to 3 months
- Weight loss of less than 10% during the 3 months before randomization
- Patient understanding French and able to complete quality of life questionnaires
- Patient having given written consent before any specific protocol procedure
- Affiliation to a social security scheme or beneficiary of such a scheme
- 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
- 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
- Absence of deficiency in dihydropyrimidine dehydrogenase activity determined by uracilemia assay (Uracilemia < 16 ng/mL)
Who cannot join
- 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.
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- Participation in a therapeutic trial in the 30 days preceding randomization
- Concomitant anticancer treatment
- Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg / day of methylprednisolone or equivalent
- 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
- Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients.
- Intended concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin
- Presence, upon selection, of psychological, family, social or geographic factors likely to influence the patient's compliance with the study and monitoring protocol.
- Pregnant or lactating woman
- 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.
- Persons deprived of their liberty, under guardianship or curatorship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
.
Read the 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 .
- Conditions
- Cancer of Head and Neck
- Keywords
- ORL cancer without front door, TPFm, inoperable tumor
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour
CisplatinDrug
cisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour
Fluoro UracilDrug
750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours)
| Study group | Role | What they receive |
|---|---|---|
| TPF (docetaxel, cisplatine, 5-FU) | Active comparator | Docetaxel, cisplatine, 5-FU administered, every 3 weeks for a total of 3 cycles Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Fluoro Uracil |
| TPFm (docetaxel, cisplatine, 5-FU) modifié | Experimental | Docetaxel, cisplatine, 5-FU administered, every 2 weeks for a total of 6 cycles Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Fluoro Uracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacity of combination of TPFm
Success rate of patients at 8 weeks
Measured: 8 weeks after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start4 Feb 2021
- Primary completion5 Aug 2025
- Study completion5 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et Cou
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Leon Berard
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04356170
- Sponsor's protocol ID
- GORTEC 2019-01
- Acronym
- TPFmORL
- Status last verified
- Aug 2025
- First submitted
- 10 Apr 2020
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04356170
- Acronym / sponsor ID
- TPFmORL / GORTEC 2019-01
- Conditions
- Cancer of Head and Neck
- Keywords
- ORL cancer without front door, TPFm, inoperable tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Groupe Oncologie Radiotherapie Tete et CouUniversity, hospital or other
- Collaborators
- Centre Leon Berard
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 5 Aug 2025 (actual)
- Study completion
- 5 Aug 2025 (actual)
- First posted
- 22 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPF (docetaxel, cisplatine, 5-FU) | Active comparator | Drug: Docetaxel, Drug: Cisplatin, Drug: Fluoro UracilDocetaxel, cisplatine, 5-FU administered, every 3 weeks for a total of 3 cycles |
| TPFm (docetaxel, cisplatine, 5-FU) modifié | Experimental | Drug: Docetaxel, Drug: Cisplatin, Drug: Fluoro UracilDocetaxel, cisplatine, 5-FU administered, every 2 weeks for a total of 6 cycles |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DocetaxelDocetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour | Drug | TPF (docetaxel, cisplatine, 5-FU), TPFm (docetaxel, cisplatine, 5-FU) modifié |
| Cisplatincisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour | Drug | TPF (docetaxel, cisplatine, 5-FU), TPFm (docetaxel, cisplatine, 5-FU) modifié |
| Fluoro Uracil750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours) | Drug | TPF (docetaxel, cisplatine, 5-FU), TPFm (docetaxel, cisplatine, 5-FU) modifié |
Primary outcome
Efficacity of combination of TPFm
Time frame: 8 weeks after the end of treatment
Success rate of patients at 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Cisplatin and Fluoro Uracil in people with Cancer of Head and Neck, run by Groupe Oncologie Radiotherapie Tete et Cou at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacity of combination of TPFm (time frame: 8 weeks after the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.