RecruitingNot ApplicableNCT05992610

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

Induction Treatment in Patients With Squamous Cell Carcinoma (SCC) of the Head and Neck Region Consisting Concomitant Chemotherapy and Low-dose Ionizing Radiotherapy

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

40 participants

Start Date

Feb 17, 2022

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of low-dose radiation and chemotherapy given before the main treatment for people with advanced squamous cell carcinoma (a type of cancer) of the head and neck. The goal is to shrink the cancer before definitive treatment. **You may be eligible if...** - You have been diagnosed with an advanced (Stage III or IV) squamous cell carcinoma of the mouth, throat, voice box (larynx), or sinuses - Your cancer has not been treated before - You are in good enough health to receive chemotherapy (good general condition) - Your cancer meets specific size and lymph node criteria **You may NOT be eligible if...** - You have already received treatment for this cancer - Your cancer has spread to distant organs (M1 stage) - Your general health is too poor to tolerate chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERChemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy

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).

Locations(1)

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

Gliwice, Silesian Voivodeship, Poland

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NCT05992610

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