Trial Title:
Induction Treatment in SCC of the Head and Neck Region - Concomitant Chemotherapy and Low-dose Radiotherapy
NCT ID:
NCT05992610
Condition:
Squamous Cell Carcinoma of Oral Cavity
Pharynx Carcinoma
Larynx Carcinoma
Paranasal Sinus Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Paclitaxel
Carboplatin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Interventional, open, allocation to concomitant chemotherapy and low-dose ionizing
radiotherapy
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Chemotherapy (carboplatin+paclitaxel) with concomitant low dose ionizing radiotherapy
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).
Arm group label:
Chemotherapy (Ch)+ Radiotherapy (RT)
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. Severity of the disease: N1 > 2 cm, N2, N3 ; T2, T3, T4, M0
3. 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).
4. Written informed consent form to the proposed therapeutic scheme.
5. Age over 18 years.
Exclusion Criteria:
1. Subjects with known or suspected hypersensitivity to any of the study mediations.
2. 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
3. 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.
4. Concomitant malignancy or history of a malignancy with a significant potential
impact to tolerability or effectivity of iCHRTL.
5. 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.
6. History of significant cerebrovascular disease within 6 months or currently
symptomatic or its implications.
7. Human Immunodeficiency Virus (HIV) infection.
8. 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.
9. 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.
10. 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.
11. 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.
12. Pregnancy or breastfeeding (women of childbearing potential must have pregnancy test
performed during screening).
13. 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.
14. 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.
15. Patients who cannot or do not want to adhere to the study Protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Maria Sklodowska-Curie National Research Institute of Oncology, Branch in Gliwice
Address:
City:
Gliwice
Zip:
44-102
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Tomasz Rutkowski, MD PhD
Phone:
+ 48 32 278 83 38
Email:
tomasz.rutkowski@io.gliwice.pl
Contact backup:
Last name:
Agnieszka Pietruszka, MD
Email:
agnieszka.pietruszka@io.gliwice.pl
Start date:
February 17, 2022
Completion date:
March 31, 2026
Lead sponsor:
Agency:
Maria Sklodowska-Curie National Research Institute of Oncology
Agency class:
Other
Collaborator:
Agency:
Medical Research Agency, Poland
Agency class:
Other
Source:
Maria Sklodowska-Curie National Research Institute of Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05992610
