search
Back to results

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

Primary Purpose

Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma, Larynx Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Squamous Cell Carcinoma of Oral Cavity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancy or breastfeeding (women of childbearing potential must have pregnancy test performed during screening). Women of childbearing potential, including women whose last menstrual period occurred in less than one year before screening, who cannot or do not want to use adequate contraception methods from the beginning of the study until 6 months after the last dose of study drug. Adequate contraception is defines as the use of oral hormonal contraceptives, an intrauterine device, a double barrier method or sexual abstinence. Men who cannot or do not want to use adequate contraception methods from the beginning of the study until 6 months after the last dose of study medication. Patients who cannot or do not want to adhere to the study Protocol.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chemotherapy (Ch)+ Radiotherapy (RT)

Arm Description

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).

Outcomes

Primary Outcome Measures

Objective response rate (ORR) after induction
Complete+partial response in percent
Objective response rate (ORR) after induction
Complete+partial response in percent
Loco-regional control (LRC) rate
Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)
Loco-regional control (LRC) rate
Rate of local lesions CR+PR+SD
Distant metastasis rate
Rate of patients with distant metastases
Distant metastasis rate
Rate of patients with distant metastases
Overall survival time (OS)
Rate of death within time from treatment start to 1 year
Overall survival time (OS)
Rate of death within time from treatment start to 3 years

Secondary Outcome Measures

Full Information

First Posted
March 13, 2023
Last Updated
August 7, 2023
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Medical Research Agency, Poland
search

1. Study Identification

Unique Protocol Identification Number
NCT05992610
Brief Title
Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy
Acronym
iCHRTL
Official Title
Induction Treatment in Patients With Squamous Cell Carcinoma (SCC) of the Head and Neck Region Consisting Concomitant Chemotherapy and Low-dose Ionizing Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Medical Research Agency, Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Non-commercial clinical study to assess: efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma. tolerability of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma. molecular and biochemical effect of low doses of ionizing radiation.
Detailed Description
40 patients with squamous cell carcinoma of oral cavity, pharynx, larynx or paranasal sinuses in stage III or IV, previously not treated for this reason and eligible for induction chemotherapy. Study treatment: Induction phase: Chemotherapy based on carboplatin 6 area under the curve (AUC) + 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). 2 cycles of induction treatment are planned. Interval between the last day of cycle I and the first day of cycle II is 7 days. After 2 weeks from second cycle Positron emission tomography (PET) and Magnetic Resonance (MR), medical case conference and qualification to further treatment: Radiotherapy (RT), Chemo-radiotherapy (CHRT) or other, depending on the medical decision. Planned based on the optimal technique for a particular clinical case preferred: Intensity Modulated Radiation Therapy (IMRT). Preparation of IMRT plan will be based on computed tomography (CT) scans. Early tolerance of radiotherapy will be assessed for local reaction. At least once every 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma, Larynx Carcinoma, Paranasal Sinus Carcinoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing radiotherapy
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chemotherapy (Ch)+ Radiotherapy (RT)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Objective response rate (ORR) after induction
Description
Complete+partial response in percent
Time Frame
1 year post-induction
Title
Objective response rate (ORR) after induction
Description
Complete+partial response in percent
Time Frame
3 years post-induction
Title
Loco-regional control (LRC) rate
Description
Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)
Time Frame
1 year post-induction
Title
Loco-regional control (LRC) rate
Description
Rate of local lesions CR+PR+SD
Time Frame
3 years post-induction
Title
Distant metastasis rate
Description
Rate of patients with distant metastases
Time Frame
1 year post-induction
Title
Distant metastasis rate
Description
Rate of patients with distant metastases
Time Frame
3 years post-induction
Title
Overall survival time (OS)
Description
Rate of death within time from treatment start to 1 year
Time Frame
Date of treatment start - to 1 year
Title
Overall survival time (OS)
Description
Rate of death within time from treatment start to 3 years
Time Frame
Date of treatment start - to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Pregnancy or breastfeeding (women of childbearing potential must have pregnancy test performed during screening). Women of childbearing potential, including women whose last menstrual period occurred in less than one year before screening, who cannot or do not want to use adequate contraception methods from the beginning of the study until 6 months after the last dose of study drug. Adequate contraception is defines as the use of oral hormonal contraceptives, an intrauterine device, a double barrier method or sexual abstinence. Men who cannot or do not want to use adequate contraception methods from the beginning of the study until 6 months after the last dose of study medication. Patients who cannot or do not want to adhere to the study Protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Rutkowski, MD PhD
Phone
+ 48 32 278 83 38
Email
Tomasz.Rutkowski@io.gliwice.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Agnieszka Pietruszka, MD
Email
agnieszka.pietruszka@io.gliwice.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Składowski, MD PhD
Organizational Affiliation
Maria Sklodowska-Curie National Research Institute of Oncology (MSCNRIO)
Official's Role
Study Chair
Facility Information:
Facility Name
The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice
City
Gliwice
State/Province
Silesia
ZIP/Postal Code
44-102
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tomasz Rutkowski, MD PhD
Phone
+ 48 32 278 83 38
Email
tomasz.rutkowski@io.gliwice.pl
First Name & Middle Initial & Last Name & Degree
Agnieszka Pietruszka, MD
Email
agnieszka.pietruszka@io.gliwice.pl

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs