Study of advacned resectable head and neck cancer with immunotherapy and radiotherapy before surgery
- Conditions
- Advanced resectable head and neck tumorMedDRA version: 21.1Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001641-40-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 14
•Newlydiagnosed,histologicallyconfirmedsquamouscellcarcinomaoftheoralcavity,pharynxand larynx;
•Selected UICC stage IV disease limited to T1-3N2-3 or T4N1-3disease;
•No distant metastases (M0)
•Lesions (both primary and nodal) must be considered amenable of complete surgicalresection;
•Patient must be cleared for surgery (medicallyoperable);
•Age >18 yrs and < 80yrs;
•Eastern cooperative oncology group (ECOG) performance status of 0 or1.
•Body weight>30kg
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2
•cN0 disease even if stage IV;
•Definitive clinical or radiologic evidence of distant metastatic disease(M1);
•Carcinoma of the head and neck of unknown primary site origin or lack of a visible primarysite;
•Prior head neck regionirradiation;
•Synchronous primarycancers;
•Any other previous malignancy within 5years;
•Active, known, or suspected autoimmune disease. Type I diabetes mellitus, hypothyroidismonly
requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the extent by which the administration of neoadjuvant Durvalumab plus fractionated radiotherapy modulates immunobiomarkers, such as T- cell activation, serum cytokines in peripheral blood as well as tumor pathological response and T-cell infiltration in the tumor and to confirm the safety of CBIT as a single agent in combination with RT.;Secondary Objective: 1.Local and regional activity of neoadjuvant Durvalumab/RT at clinical/radiological (morphologicalandfunctional) examination before surgery.<br>2. Safety of combination in terms of surgery<br>3. Feasibility of adjuvant radiotherapy + chemotherapy after surgery;Primary end point(s): Immunobiomarkers modulation;Timepoint(s) of evaluation of this end point: Baseline, day 4, 18, 28, before and after postoperative radiotherapy
- Secondary Outcome Measures
Name Time Method