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Phase III trial of laryngeal preservation comparating Induction chemotherapy with cisplatin, 5-fluorouracil and docetaxel (TPF) followed by radiotherapy and concomitant administration of radiotherapy with cisplatin (SALTORL).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513976-16-00
Enrollment
256
Registered
2024-07-15
Start date
2015-06-26
Completion date
Unknown
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous cell carcinomas of the larynx or hypopharynx locally advance

Brief summary

Survival with preservation of laryngeal and pharyngoesophageal function. The following events are considered: death, total laryngectomy, tracheotomy at 24 months, gastric tube at 24 months, local recurrence not accessible to salvage treatment. The causes of death will be specified

Detailed description

Overall survival. Events are considered to be: death from any cause., Survival without recurrence. Events are considered: death from any cause, local recurrence, lymph node recurrence, distant metastases, Locoregional control. Events are considered: local recurrence, lymph node recurrence, Metastasis-free survival and incidence of metastases, Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy, Laryngeal preservation. Total laryngectomy is considered an event, Response rate to induction chemotherapy, Toxicity of the treatments under study. By distinguishing between acute and late toxicities, Feasibility and morbidity of salvage surgery: evaluation of the number of recurrences that could be successfully treated by salvage surgery and description of the operative consequences., Qualité de la fonction laryngée et pharyngo-oesophagienne. Seront évaluées par échelle qualitative : la voix, la déglutition (y compris le type d’alimentation) et la respiration au repos et à l’effort. La qualité de la réhabilitation des patients laryngectomisés sera également analysée.

Interventions

DRUGsolution à diluer pour perfusion
DRUGCisplatin 1 mg/ml concentrate for solution for Infusion

Sponsors

Groupe Oncologie Radiotherapie Tete Cou
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Survival with preservation of laryngeal and pharyngoesophageal function. The following events are considered: death, total laryngectomy, tracheotomy at 24 months, gastric tube at 24 months, local recurrence not accessible to salvage treatment. The causes of death will be specified

Secondary

MeasureTime frame
Overall survival. Events are considered to be: death from any cause., Survival without recurrence. Events are considered: death from any cause, local recurrence, lymph node recurrence, distant metastases, Locoregional control. Events are considered: local recurrence, lymph node recurrence, Metastasis-free survival and incidence of metastases, Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy, Laryngeal preservation. Total laryngectomy is considered an event, Response rate to induction chemotherapy, Toxicity of the treatments under study. By distinguishing between acute and late toxicities, Feasibility and morbidity of salvage surgery: evaluation of the number of recurrences that could be successfully treated by salvage surgery and description of the operative consequences., Qualité de la fonction laryngée et pharyngo-oesophagienne. Seront évaluées par échelle qualitative : la voix, la déglutition (y compris le type d’alim

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026