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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Poland
The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice
RECRUITING
Gliwice
Contact Information
Primary
Tomasz Rutkowski, MD PhD
Tomasz.Rutkowski@io.gliwice.pl
+ 48 32 278 83 38
Backup
Agnieszka Pietruszka, MD
agnieszka.pietruszka@io.gliwice.pl
Time Frame
Start Date: 2022-02-17
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 40
Treatments
Experimental: Chemotherapy (Ch)+ Radiotherapy (RT)
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).
Sponsors
Collaborators: Medical Research Agency, Poland
Leads: Maria Sklodowska-Curie National Research Institute of Oncology

This content was sourced from clinicaltrials.gov

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