Squamous Cell Carcinoma of Oral CavityiCHRTLNCT05992610

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

A study testing Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy in people with Squamous Cell Carcinoma of Oral Cavity and Pharynx Carcinoma, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Non-commercial clinical study to assess: 1. efficacy of iCHRTL in patients with advanced squamous cell carcinoma of oral cavity, pharynx carcinoma, larynx carcinoma or paranasal sinus carcinoma. 2. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma, Larynx Carcinoma
What is being tested?: Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 sitePoland
Study dates: 17 Feb 2022to 30 Jun 2027
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 19Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice
Gliwice, Silesian Voivodeship, 44-102

Other trials in Poland

About this study

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

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.

Read the 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.

Conditions: Squamous Cell Carcinoma of Oral Cavity, Pharynx Carcinoma, Larynx Carcinoma, Paranasal Sinus Carcinoma
Being tested: Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy
Medical subject headings: Squamous Cell Carcinoma of Head and Neck, Pharyngeal Neoplasms, Laryngeal Neoplasms, Paranasal Sinus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapyOther
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).

Study groups in NCT05992610
Study group	Role	What they receive
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). Receives: Other: Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Feb 202230 Jun 2027

First posted15 Aug 2023
Study start17 Feb 2022
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Squamous Cell Carcinoma of Oral CavityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing radiotherapy
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05992610
Sponsor's protocol ID: iCHRTL
Acronym: iCHRTL
Status last verified: Oct 2026
First submitted: 13 Mar 2023
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Active, not recruitingPhase 3
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
Neck Squamous Cell Carcinoma of Unknown Primary, Recurrent Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 2
Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1
Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
HNSCC,Larynx, Pharynx and Oral Cavity, Squamous Cell Carcinoma

All Squamous Cell Carcinoma of Oral Cavity trials