Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT

Korábbi kezelés

• Tumour available immediately to partial surgery.
• Other malignancies within 5 years prior to randomization, with the exception of adequately treated basal skin cancer and carcinoma in situ of the cervix.
• 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.
• Concomitant use of phenytoin, carbamazepine, barbiturates and rifampicin.

Más betegség

• Allergy to iodine.
• Hypersensitivity to Docetaxel, Cisplatin or at one of their excipients.

Laborértékek

• Patients with AST or ALT\> 1.5xULN associated with alkaline phosphatase \> 2.5x LNS will not be eligible for testing.

Életkor

• Patient (male or female) of childbearing age not taking adequate contraceptive measures.

Egyéb

• 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.
• tumor requiring circular hypopharyngectomie
• N3 nodal injury
• Vaccination against yellow fever recent or anticipated
• Deficit known dihydropyrimidine dehydrogenase (DPD)
• symptomatic neuropathy grade ≥2 with NCI-CTC.
• Clinical alteration of hearing function.
• 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 deprived of their liberty, without guardianship or curatorship.

• 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.