Non Elective Vulnerable Elderly Radiotherapy

NCT04832555 | Recruiting DMC

• 1 other identifier: NEVER
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Keywords

Elderly; Vulnerable; Radiotherapy; Non-elective Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Loco-regional control

  clinical or radiological (RECIST 1.1) disease progression from end of treatment with tumor present, or to the date of salvage surgery of primary tumor with tumor present performed for clinical or radiological (RECIST 1.1) disease progression, whichever comes first.

  24 months after the start of treatment

Secondary Outcomes (5)

• rate of severe sub-acute or late toxicity

  at 6 and 12 months after the completion of radiotherapy

• Cause-specific mortality rates

  within 3 months after start of treatment

• overall survival

  5 years

• progression free survival

  12 and 24 months

• G8 role

  6 and 12 months

Other Outcomes (1)

• radiomics

  through study completion, an average of 5 year

Study Arms (1)

Open: non elective irradiation

EXPERIMENTAL

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

Radiation: Non elective radiotherapy

Interventions

Non elective radiotherapy RADIATION

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

Open: non elective irradiation

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• D-conformational radiotherapy technique

Sponsors & Collaborators

• Azienda Ospedaliero Universitaria Policlinico Modena: lead

Study Sites (1)

AOUPoliclinicoModena

Modena, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Elisa D'Angelo

  Azienda Ospedaliero Universitaria Policlinico Modena

  STUDY CHAIR

Central Study Contacts

Pasquale Mighali, MD

CONTACT

+39 0594225868; pasqualemighali@aou.mo.it

Elisa D'Angelo, MD

CONTACT

+39 3934317599; dangelo.elisa@aou.mo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, MD

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: April 6, 2021
• Study Start: February 20, 2021
• Primary Completion: July 1, 2023
• Study Completion: February 1, 2026
• Last Updated: April 6, 2021

Record last verified: 2021-04

Locations

IT (1)