EUCTR2019-001641-40-IT
Active, not recruiting
Phase 1
Induction Durvalumab (MEDI4736) & Radiotherapy (RT) forLocally Advanced but Resectable Head and Neck Squamous Cell Carcinomas: A Pilot Study - ESR-17-12933
ISTITUTI FISIOTERAPICI OSPITALIERI0 sites14 target enrollmentMay 24, 2021
ConditionsAdvanced 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]
DrugsImfinzi
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced resectable head and neck tumor
- Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Enrollment
- 14
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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