Docetaxel: Docetaxel 75 mg / m² administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion of one hour followed by cisplatin 75 mg / m² administered on day 1 hour infusion followed by 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
Cisplatin: Cisplatin: 75 mg/m² for experimental arm and 100mg/m² for comparator arm administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion.
Fluorouracil: 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
radiotherapy: Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
Study summary
This study compare the survival without laryngeal dysfunction 2 years after the end of treatment, obtained by chemotherapy followed by radiotherapy or chemotherapy with cisplatin administrated during radiotherapy.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Squamous cell carcinoma of the larynx or hypopharynx, histologically proven, locally advanced:
* T2 not accessible to a supra-cricoid partial laryngectomy or not,
* T3 without massive infiltration by endolarynx transglottic injury,
* N0 to N2c
* No distant metastasis
* No associated cancer or earlier
* Patients Previously Untreated
* Age\> 18 years and \<75 years
* PS 0 or 1 according to WHO
* Tumor volume assessable by RECIST.
* Absence of distant metastasis, confirmed by chest TDM, abdominal ultrasound (or TDM) in case of abnormal liver function and bone scan if local symptoms.
* Absence of any participation in a clinical trial within 30 days prior to inclusion.
* Absence of any concomitant cancer treatment.
* Absence of any chronic treatment ( ≥3 months) with a daily corticosteroid dose is ≥20 mg / day of methylprednisolone or equivalent.
* Hematological function: neutrophils ≥1.5 x 109 / L, platelets ≥100 x 109 / l, hemoglobin ≥10 g / dl (or 6.2 mmol / l).
* Hepatic function: normal total bilirubin; AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (LNS) of each center; alkaline phosphatase ≤ 5 x LNS.
* Renal function: serum creatinine ≤ 120 mol / l (1.4 mg / dl); if creatinine \> 120 mol / l, creatinine clearance should be ≥ 60 ml / min.
* calculated creatinine clearance (Crockcroft formula) or measured ≥ 60 ml / min
* Estimated life expectancy ≥ 3 months
* Weight loss less than 10% over the last 3 months
* Patient has given its written consent before any specific procedure of the Protocol.
* Women and men of childbearing age should have accepted a medically effective contraception during the treatment period and at least 6 months after discontinuation of study treatments (Docetaxel, 5-Fluorouracil and Cisplatin. If pregnancy is declared by a patient or partner of a patient, it must be followed to know the evolution of pregnancy.
Exclusion Criteria:
* transglottic T3 with massive infiltration of hemilarynx or T4 with massive cartilaginous tumor lysis or reverse cricoarythénoïdenne region or posterior hypopharyngeal wall
* tumor requiring the completion of an immediately tracheotomy.
* Tumour available immediately to partial surgery.
* tumor requiring circular hypopharyngectomie
* N3 nodal injury
* Vaccination against yellow fever recent or anticipated
* Deficit known dihydropyrimidine dehydrogenase (DPD)
* Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix.
* Patients with AST or ALT\> 1.5xULN associated with alkaline phosphatase \> 2.5x LNS will not be eligible for testing.
* symptomatic neuropathy grade ≥2 with NCI-CTC.
* Clinical alteration of hearing function.
* Other concomitant serious medical conditions (partial list):
* Unstable cardiac disease despite treatment.
* Myocardial infarction within 6 months prior to trial entry.
* Neurological or psychiatric history such as dementia, seizures;
* Severe uncontrolled infection.
* Significant gastrointestinal abnormalities, including those that require parenteral nutrition, active peptic ulcer disease and a history of surgical procedures affecting absorption
* Obstructive pulmonary disease requiring hospitalization in the year before inclusion.
* Unstable diabetes or other cons-indications to corticosteroids.
* Significant ophthalmologic abnormality.
* Moderate or severe eczema.
* Allergy to iodine.
* Hypersensitivity to Docetaxel, Cisplatin or at one of their excipients.
* Concomitant use of phenytoin, carbamazepine, barbiturates and rifampicin.
* Presence, selection, psychological factors, family, social or geographical may alter patient compliance with the study protocol and follow-up, a criterion of non-inclusion. These factors should be discussed with the patient before inclusion in the trial.
* Pregnant or nursing women.
* Patient (male or female) of childbearing age not taking adequate contraceptive measures.
* Patient deprived of their liberty, without guardianship or curatorship.
Primary outcome measure(s)
free survival — 24 months after treatment initiation Minimum time between randomization and the occurrence of events such as: death, total laryngectomy, tracheotomy.
Trial sites (1)
Facility
City
Region
Status
Centre Jean Bernard
Le Mans
France
More Groupe Oncologie Radiotherapie Tete et Cou trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.