Non Elective Vulnerable Elderly Radiotherapy

NCT ID: NCT04832555

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-20
• Study Completion Date: 2026-02-28

Brief Summary

To evaluate whether patients defined "non-fit for curative non-surgical radio-chemotherapy" and therefore treated with RT alone addressed only to non-elective sites of disease, could obtain a non-inferior loco-regional control compared to similar historical cohorts.

Detailed Description

The current standard approach for head and neck malignancies cannot be considered the gold standard for elderly patients, except in carefully selected cases. Given the relevance of this population, scientific societies also suggest to propose prospective studies for this subset of frail patients (European Organization for Research and treatment of cancer (EORTC), European Society for Medical oncology (ESMO)). In addition, it is necessary to collect data on specific categories, which are as homogeneous as possible. Therefore, the purpose of this study is to evaluate efficacy and safety of a tailored RT approach administered with a curative intent in a subset of frails elderly patients not candidates neither to standard concurrent RT-CT / RT-cetuximab nor to palliative treatment/best supportive care.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open: non elective irradiation

Patients within inclusion criteria will be enrolled in the experimental treatment: a radiation therapy addressed to non elective site of disease and with a simultaneous integrated boost

Group Type: EXPERIMENTAL

Non elective radiotherapy

Intervention Type: RADIATION

Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.

Interventions

Non elective radiotherapy

Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• locally advanced non-metastatic HNSCC patients older than 70 years
• Primary tumor clinically and radiologically detectable and measurable (staging according to ed. TNM VII and also VIII.
• patients defined by the tumor board (ENT, Oncologist, Radiotherapist, Nutritionist) as 1) not eligibles for RTCT / RT-cetuximab treatment 2) not amenable to radical surgery and 3) not candidates for treatments with palliative intent/best supportive care
• Availability of staging with CT/PET for distant metastasis and CT/MRI for primary tumor
• Karnofsky performance status (KPS) ≥60/100
• Oropharynx , Hypopharynx and Larynx, Oral cavity: stage III and IV and Unknown primitive P16-POSITIVE

Exclusion Criteria

• Age less than 70 years

• Staging exams done 45 days before the date of the beginning of the treatment
• Subsites: nasopharynx, salivary glands, paranasal sinuses. Metastatic disease
• Gross total excision
• All subsites concerned if N3.
• Squamous cell neoplasms of the glottic larynx T1-T2 N0.
• Unknown primary HPV negative or EBV positive.
• Presence of distant metastases or sub-clavicular lymphadenopathies.
• Previous surgery on T and/or N except diagnostic tonsillectomy.
• 3D-conformational radiotherapy technique

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero Universitaria Policlinico Modena

OTHER

Sponsor Role: lead

Responsible Party

Elisa D'angelo

Medical Doctor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisa D'Angelo

Role: STUDY_CHAIR

Azienda Ospedaliero Universitaria Policlinico Modena

Locations

AOUPoliclinicoModena

Modena, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Pasquale Mighali, MD

Role: CONTACT

pasqualemighali@aou.mo.it

+39 0594225868

Elisa D'Angelo, MD

Role: CONTACT

dangelo.elisa@aou.mo.it

+39 3934317599

Facility Contacts

Pasquale Mighali

Role: primary

pasquale.mighali@aou.mo.it

+39 0594225868

Other Identifiers

NEVER

Identifier Type: -

Identifier Source: org_study_id