Randomized trial evaluating adapted chemotherapy in patients with squamous carcinoma

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] - Hemic and Lymphatic Diseases [C15]

Trial duration

4 Feb 2021 → 5 Aug 2025

Decision date (initial)

2024-04-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512456-38-00

EudraCT number

2020-000770-21

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Evaluate the effectiveness of the combination of cisplatin-5FU-docetaxel at adapted doses (TPFm) in terms of response to treatment without toxicity.

Secondary objectives 10

1. Overall survival
2. Progression-free survival
3. Local and/or locoregional control
4. Laryngeal preservation
5. Distant metastases (incidence and survival)
6. Toxicities of complementary treatment to induction treatment
7. Compliance with induction treatment
8. Assessment of quality of life
9. Hospitalization or extension of hospitalization for treatment toxicity
10. Length of hospitalization during induction treatment

Conditions and MedDRA coding

locally advanced squamous cell carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, histologically proven (several ENT locations are authorized), lymphadenopathy without portal of entry
2. Tumor considered inoperable or for which surgery would be mutilating
3. Patient not previously treated for ORL cancer
4. Age > 18 years and < 75 years
5. PS 0 or 1 according to WHO
6. At least one measurable lesion according to RECIST 1.1 criteria
7. Patient able to receive TPF according to well-defined criteria
8. Estimated life expectancy greater than or equal to 3 months.

Exclusion criteria 12

1. Cancers of the nasopharynx, sinuses or nasal cavities, and any histology other than squamous cell carcinoma
2. Recent or planned yellow fever vaccination
3. Deficiency of dihydropyrimidine dehydrogenase (DPD) activity
4. History of other cancer except in situ cervical cancer or controlled basal cell carcinoma. Patients in remission from cancer treated more than 3 years ago are eligible. Patients treated with surgery alone for head and neck cancer in the previous 3 years are eligible.
5. Previous treatment of head and neck cancer by chemotherapy or radiotherapy (Patients treated by surgery alone for head and neck cancer in the previous 3 years are eligible).
6. Presence of distant metastasis.
7. Participation in a therapeutic trial within 30 days preceding randomization
8. Concomitant anticancer treatment
9. Patient under chronic treatment (3 months) with corticosteroid whose daily dosage is 10 mg/day of methylprednisolone or equivalent
10. Other existing serious medical pathologies
11. Known hypersensitivity to docetaxel, cisplatin 5FU or one of their excipients
12. Planned concomitant use of phenytoin, carbamazepine, barbiturates or rifampicin

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of patient success at 8 weeks

Secondary endpoints 10

1. Overall survival defined by the time between the date of randomization and the date of death from any cause. In the absence of notification of death, survival data will be censored on the date of last news without progression.
2. Progression-free survival defined by the time between the date of randomization and the date of first evidence of progression, the date of death from any cause or the date of last news without progression.
3. Rate of patients in local and/or locoregional control of the disease at week 8 ± 3 days.
4. Rate of patients with larynx preservation. Is considered as total laryngectomy event.
5. Metastasis-free survival defined by the time between the date of randomization and the date of first evidence of metastatic progression, or the date of death, whatever the cause.
6. Toxicity of complementary treatment to induction treatment.
7. Rate of patients who received the entire induction treatment.
8. Rate of patients who received the entire complementary treatment to induction treatment.
9. Hospitalization or extension of hospitalization for toxicity linked to the treatments under study.
10. Quality of life according to the EORTC QLQ-C30 and EORTCH& N35 questionnaires

Investigational products

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

Test 3

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

Jérôme FAYETTE

Public contact point

Organisation

Groupe Oncologie Radiotherapie Tete Cou

Contact name

Adeline PECHERY

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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