Trial Evaluating Adapted Chemotherapy in Patients With Squamous Carcinoma

NCT04356170 | Completed Phase 2 DMC

• 1 other identifier: GORTEC 2019-01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Cancer of Head and Neck

Keywords

ORL cancer without front door, TPFm, inoperable tumor

Outcome Measures

Primary Outcomes (1)

• Efficacity of combination of TPFm

  Success rate of patients at 8 weeks

  8 weeks after the end of treatment

Other Outcomes (8)

• Overall survival

  3 months after the end of treatment

• Progression free survival

  3 months after the end of treatment

• incidence of local and/or locorégional failure

  3 months after the end of treatment

Study Arms (2)

TPF (docetaxel, cisplatine, 5-FU)

ACTIVE COMPARATOR

Docetaxel, cisplatine, 5-FU administered, every 3 weeks for a total of 3 cycles

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

Drug: Docetaxel; Drug: Cisplatin; Drug: Fluoro Uracil

Interventions

Docetaxel DRUG

Docetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour

TPF (docetaxel, cisplatine, 5-FU); TPFm (docetaxel, cisplatine, 5-FU) modifié

Cisplatin DRUG

cisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour

TPF (docetaxel, cisplatine, 5-FU); TPFm (docetaxel, cisplatine, 5-FU) modifié

Fluoro Uracil DRUG

750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours)

TPF (docetaxel, cisplatine, 5-FU); TPFm (docetaxel, cisplatine, 5-FU) modifié

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Groupe Oncologie Radiotherapie Tete et Cou: lead
• Centre Leon Berard: collaborator

Study Sites (1)

Centre Leon Berard

Lyon, 69008, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 22, 2020
• Study Start: February 4, 2021
• Primary Completion: August 5, 2025
• Study Completion: August 5, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Locations

FR (1)