Induction treatment of patients with head and neck squamous cell carcinoma using simultaneous chemotherapy and low-dose radiotherapy (iCHRTL)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Feb 2022 → ongoing

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Agencja Badań Medycznych (project ABM no. 2020/ABM/01/00021).

External identifiers

EU CT number

2024-517480-23-00

EudraCT number

2021-005620-37

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

- Evaluation of the efficacy of iCHRTL in patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses
- Assessment of iCHRTL tolerance in patients with advanced squamosus cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses
- Evaluation of the molecular and biochemical (immunological) effect of low doses of ionizing radiation

Secondary objectives 5

1. objective response rate after induction assessment (ORR)
2. local and nodal healing rate assessement (LRC)
3. progression-free survival assessment
4. overall survival assessment
5. assessment of the rate of side effects of iCHRTL

Conditions and MedDRA coding

Head and neck squamous cell carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients with advanced squamous cell carcinoma of the oral cavity, pharynx, larynx or paranasal sinuses
2. Severity of the disease: N1> 2 cm, N2, N3; T2, T3, T4, M0
3. Patient eligible for radical treatment with induction chemotherapy (general condition at least good, no significant additional conditions disqualifying from induction chemotherapy)
4. Signed informed consent to participate in the study
5. ≥ 18 years of age

Exclusion criteria 15

1. Known or suspected hypersensitivity to any of the investigational drugs
2. Baseline values for the following parameters (during the screening phase): -Creatinine> 2.0 times upper limit of normal (unless creatinine clearance is normal); - Total bilirubin> 1.5 times the upper limit of normal (except for hyperbilirubinemia due to Gilbert's syndrome); - ALT > 2.5 times the upper limit of normal; - Alkaline phosphatase activity> 2.5 times the upper limit of normal
3. First treatment with any unauthorized drug or experimental treatment within 5 half-lives of this substance or 4 weeks prior to enrollment in a study (longer period must be taken), or currently enrollment in other interventional clinical trials
4. Coexistence of another neoplasm or a history of neoplastic disease with a significant potential influence on the tolerability or efficacy of iCHRTL
5. Chronic or active infection requiring the use of antibiotics, antifungal medications, or antiviral medications, such as, but not limited to, chronic kidney infection, chronic bronchospastic respiratory infection, tuberculosis, or active hepatitis C
6. Significant history of cerebrovascular disease within 6 months or current symptomatic or sequelae
7. HIV infection
8. Clinically significant heart disease including unstable angina, myocardial infarction in the 6 months prior to study entry, severe NYHA III-IV congestive heart failure, arrhythmias, unless treatable, except for extrasystole or minimal contractions conduction disturbances
9. Significant co-morbidities that are untreatable, such as, but not limited to, kidney, liver, gastrointestinal, endocrine, respiratory, neurological, brain, and mental illness that the investigator believes may pose a risk to the patient
10. Hepatitis B virus (HBV) infection defined as a positive test for HBsAg. In addition, in the case of a negative HBsAg test result, but a positive HBcAb test result (regardless of HBsAb status), HBV DNA testing should be performed and in the case of a positive result, the patient cannot be included in the trial
11. Hepatitis C virus (HCV) infection defined as a positive HCAb test, in which case an HCV RIBA immunoblot test from the same sample should be performed to confirm the result
12. Pregnancy or breastfeeding (women of childbearing age should undergo a pregnancy test at screening)
13. Women of childbearing potential, including those with their last menstrual period less than one year prior to screening, who are unable or unwilling to use adequate contraception methods from the beginning of the study to seven months after the last intake dose of the study drug.
14. Men who are unable or unwilling to use adequate contraceptive methods from the start of the study to six months after taking the last dose of study medication
15. Patients unable or unwilling to adhere to the study protocol.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Objective response rate after induction assessment (ORR)
2. Local and nodal healing rate assessement (LRC)
3. Assessment of the frequency of individual adverse events
4. Progression-free survival assessment (PFS)
5. Overall survival assessment (OS)

Secondary endpoints 3

1. Distant metastases rate assessment
2. Evaluation of the molecular and biochemical (immunological) effect of low doses of ionizing radiation
3. Relapse free survival (RFS) assessment

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Sponsor organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Address

Ul. Wybrzeze Armii Krajowej 15

City

Gliwice

Postcode

44-102

Country

Poland

Scientific contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Prof. Tomasz Rutkowski

Public contact point

Organisation

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Contact name

Prof. Tomasz Rutkowski

Locations

1 EU/EEA country · 1 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 6 files

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

Application history

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