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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
40
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).
The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice
Gliwice, Silesian Voivodeship, Poland
RECRUITINGObjective response rate (ORR) after induction
Complete+partial response in percent
Time frame: 1 year post-induction
Objective response rate (ORR) after induction
Complete+partial response in percent
Time frame: 3 years post-induction
Loco-regional control (LRC) rate
Rate of local lesions complete response (CR) +partial response (PR)+stable disease (SD)
Time frame: 1 year post-induction
Loco-regional control (LRC) rate
Rate of local lesions CR+PR+SD
Time frame: 3 years post-induction
Distant metastasis rate
Rate of patients with distant metastases
Time frame: 1 year post-induction
Distant metastasis rate
Rate of patients with distant metastases
Time frame: 3 years post-induction
Overall survival time (OS)
Rate of death within time from treatment start to 1 year
Time frame: Date of treatment start - to 1 year
Overall survival time (OS)
Rate of death within time from treatment start to 3 years
Time frame: Date of treatment start - to 3 years
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