Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT (NCT03340896) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT
France256 participantsStarted 2015-06-25
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 befo…