Phase III trial of laryngeal preservation comparating chemotherapy followed by radiotherapy to chemotherapy administrated during radiotherapy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

26 Jun 2015 → ongoing

Decision date (initial)

2024-07-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-513976-16-00

EudraCT number

2014-005188-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Compare survival without laryngeal or pharyngoesophageal dysfunction, obtained by triple therapy (TPF) followed by external radiotherapy or by the concomitant combination of external radiotherapy and Cisplatin.

Secondary objectives 10

1. Overall survival
2. Locoregional control
3. Survival without recurrence
4. Distant metastases (incidence and survival)
5. Survival without laryngeal or pharyngoesophageal dysfunction with dynamic swallowing videocopy or according to VHI/DHI (if videocopy is missing)
6. Laryngeal preservation
7. Response rate to induction chemotherapy
8. Acute and late toxicity
9. Feasibility and morbidity of salvage surgery
10. Quality of laryngeal and pharyngoesophageal function

Conditions and MedDRA coding

squamous cell carcinomas of the larynx or hypopharynx locally advance

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Squamous cell carcinoma of the larynx or hypopharynx (excluding the retro-cricoarytenoid region and the posterior wall), histologically proven, locally advanced requiring total (pharyngo)-laryngectomy provided that the latter is feasible straight away and does not require circular hypopharyngectomy: -T2 not accessible to supra-cricoid partial laryngectomy or not, -T3 without massive infiltration of the endolarynx by a transglottic lesion, -N0 to N2c -Without distant metastasis -Without associated or previous cancer
2. Patient not previously treated
3. PS 0 or 1
4. Tumor volume evaluable according to RECIST
5. Absence of distant metastasis, confirmed by chest CT, abdominal ultrasound (or CT) in the event of abnormal liver function, and bone scintigraphy in the event of local symptoms.

Exclusion criteria 7

1. Transglottic T3 with massive infiltration of the hemilarynx or T4 with massive cartilaginous lysis or tumor of the retrocricoarytenoid region or the posterior hypopharyngeal wall
2. Tumor requiring immediate tracheotomy.
3. Tumor immediately accessible to partial surgery
4. Tumor requiring circular hypopharyngectomy
5. N3 lymph node lesion
6. Patients with AST or ALT > 1.5 LNS associated with alkaline phosphatase > 2.5 x LNS will not be eligible for the trial
7. Clinical alteration of hearing function

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 10

1. Overall survival. Events are considered to be: death from any cause.
2. Survival without recurrence. Events are considered: death from any cause, local recurrence, lymph node recurrence, distant metastases
3. Locoregional control. Events are considered: local recurrence, lymph node recurrence
4. Metastasis-free survival and incidence of metastases
5. Survival with preservation of laryngeal and pharyngoesophageal function according to dynamic swallowing videoscopy
6. Laryngeal preservation. Total laryngectomy is considered an event
7. Response rate to induction chemotherapy
8. Toxicity of the treatments under study. By distinguishing between acute and late toxicities
9. 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.
10. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Groupe Oncologie Radiotherapie Tete Cou

Sponsor organisation

Groupe Oncologie Radiotherapie Tete Cou

Address

4 B Rue Emile Zola

City

Tours

Postcode

37000

Country

France

Scientific contact point

Organisation

Groupe Oncologie Radiotherapie Tete Cou

Contact name

Yoann POINTREAU

Public contact point

Organisation

Groupe Oncologie Radiotherapie Tete Cou

Contact name

Laura SINIGAGLIA

Locations

1 EU/EEA country · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications