Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy

NCT05992610 | Recruiting DMC

• 1 other identifier: iCHRTL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Non-commercial clinical study to assess:

1. 1.efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.
2. 2.tolerability of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma.
3. 3.molecular and biochemical effect of low doses of ionizing radiation.

Conditions

Squamous Cell Carcinoma of Oral Cavity; Pharynx Carcinoma; Larynx Carcinoma; Paranasal Sinus Carcinoma

Outcome Measures

Primary Outcomes (8)

• Objective response rate (ORR) after induction

  Complete+partial response in percent

  1 year post-induction

• Objective response rate (ORR) after induction

  Complete+partial response in percent

  3 years post-induction

• Loco-regional control (LRC) rate

  Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)

  1 year post-induction

• Loco-regional control (LRC) rate

  Rate of local lesions CR+PR+SD

  3 years post-induction

• Distant metastasis rate

  Rate of patients with distant metastases

  1 year post-induction

• Distant metastasis rate

  Rate of patients with distant metastases

  3 years post-induction

• Overall survival time (OS)

  Rate of death within time from treatment start to 1 year

  Date of treatment start - to 1 year

• Overall survival time (OS)

  Rate of death within time from treatment start to 3 years

  Date of treatment start - to 3 years

Study Arms (1)

Chemotherapy (Ch)+ Radiotherapy (RT)

EXPERIMENTAL

Induction phase: Chemotherapy based on carboplatin 6 AUC (area under the curve) + paclitaxel 75 mg/m2 carboplatin 6 AUC 30-minute infusion on D: 1 (maximum carboplatin dose is 700 mg) paclitaxel 75 mg/m2 1-hour infusion on D: 1, 8, 15 Radiotherapy: D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).

Other: Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy

Interventions

Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy OTHER

Chemotherapy based on carboplatin 6 AUC + paclitaxel 75 mg/m2. Radiotherapy: D:1 - 2 x 0,5 Gy (first dose up to one hour after the end of the carboplatin infusion, second dose 3 to 6 hours later), D:2 - 2 x 0,5 Gy (interval between doses not less than 3 hours), D:8 and D:15 - 2 x 0,5 Gy (first dose up to one hour after the end of the chemotherapeutic infusion, second dose 3 to 6 hours later).

Chemotherapy (Ch)+ Radiotherapy (RT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with squamous cell carcinoma of oral cavity, upper, middle, lower pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma in advanced stage III or IV and previously not treated for this reason.
• Severity of the disease: N1 \> 2 cm, N2, N3 ; T2, T3, T4, M0
• Patient eligible for radical treatment with induction chemotherapy (at least in good general condition (ZUBROD 0-1) with no significant additional diseases disqualifying from induction chemotherapy).
• Written informed consent form to the proposed therapeutic scheme.
• Age over 18 years.

You may not qualify if:

• Subjects with known or suspected hypersensitivity to any of the study mediations.
• Baseline values for the following parameters (in the screening phase):
• Creatinine \>2,0 x upper limit of normal (ULN) - unless creatinine clearance is normal
• Total bilirubin \>1,5 x ULN (except for hyperbilirubinemia caused by Gilbert's syndrome)
• Alanine Transaminase (ALT) activity, Aspartate Transaminase (ASPAT) \>2,5 x ULN
• Alkaline phosphatase activity \>2,5 x ULN
• Prior treatment with any unauthorized medication or investigational treatment before the 5 half-lives of that substance or 4 weeks prior to study entry (a longer period of time should be assumed), or subjects currently enrolled to other interventional clinical trials.
• Concomitant malignancy or history of a malignancy with a significant potential impact to tolerability or effectivity of iCHRTL.
• Chronic or active infection requiring antibiotic, antifungal or antiviral treatment, such as, but not limited to: chronic kidney infection, chronic respiratory tract infection with bronchospasm, tuberculosis or active hepatitis C virus infection.
• History of significant cerebrovascular disease within 6 months or currently symptomatic or its implications.
• Human Immunodeficiency Virus (HIV) infection.
• Clinically significant heart disease including unstable angina, myocardial infarction within 6 months prior to study entry, severe congestive circulatory failure class New York Heart Association (NYHA) III-IV, arrhythmias unless it is treated, except for collateral contractions or minimal conduction disorders.
• Significant concomitant disease that cannot be treated, such as, but not limited to kidney, liver, gastrointestinal, endocrine system, respiratory, neurological and brain diseases and mental illnesses that may pose a risk to the patient in the opinion of the investigator.
• Active hepatitis B virus (HBV) infection, defined as having a positive Hepatitis B surface antigen (HBsAg) test. Moreover, in case of a negative HBsAg test result but a positive Hepatitis B core Antibody (HBcAb) test result (regardless of HBsAb status), HBV DNA should be determined and in case of a positive result the patient cannot be included to the study.
• Active hepatitis C virus (HCV) infection, defined as having a positive Hepatitis C Antibody (HCAb) test, in which case Hepatitis C virus recombinant immunoblot assay (HCV RIBA) should be determined from the same sample to confirm the result.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice

Gliwice, Silesian Voivodeship, 44-102, Poland

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Pharyngeal Neoplasms; Laryngeal Neoplasms; Paranasal Sinus Neoplasms

Interventions

Drug Therapy; CP protocol

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nose Neoplasms; Nose Diseases; Paranasal Sinus Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Krzysztof Składowski, MD PhD

  Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)

  STUDY CHAIR

Central Study Contacts

Tomasz Rutkowski, MD PhD

CONTACT

+ 48 32 278 83 38; Tomasz.Rutkowski@io.gliwice.pl

Agnieszka Pietruszka, MD

CONTACT

agnieszka.pietruszka@io.gliwice.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing radiotherapy

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: August 15, 2023
• Study Start: February 17, 2022
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2026
• Last Updated: August 15, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)