Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma

NCT05650034 | Unknown

• 1 other identifier: RO2105-30901
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized prospective trial evaluating the non- inferiority of de-escalating the volume and/or dose of elective nodal irradiation in post-operative head and neck squamous cell carcinomas.

Conditions

Head and Neck Carcinoma

Keywords

Post operative radiotherapy; Elective nodal irradiation; Head and neck SCC; Elective nodal omission; De-escalation

Outcome Measures

Primary Outcomes (1)

• Regional failure in the omitted/de-escalated elective nodal irradiation site

  Baseline to 1 year

Secondary Outcomes (3)

• Acute toxicity

  Baseline to 6 months

• Late toxicity

  Baseline to 1 year

• Overall survival

  Baseline to 2 years

Study Arms (1)

Elective nodal de-escalation arm

EXPERIMENTAL

Omission of elective nodal irradiation in N0 hemi-neck of well lateralized H\&N SCCs ( pN0 or by PETCT). Dose de-escalation of elective nodal irradiation in N0 hemi-neck of midline H\&N SCCs ( pN0 or by PETCT).

Radiation: Elective nodal de-escalation arm

Interventions

Elective nodal de-escalation arm RADIATION

Omission of elective nodal irradiation in N0 hemi-neck of well lateralized H\&N SCCs ( pN0 or by PETCT). Dose de-escalation of elective nodal irradiation in N0 hemi-neck of midline H\&N SCCs ( pN0 or by PETCT).

Elective nodal de-escalation arm

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a Karnofsky performance score of 70% or more.
• Completely or partially resected head and neck SCC. This includes: The oral cavity (lips, buccal mucosa, oral tongue, floor of mouth, gingiva, retromolar trigone, and hard palate), maxilla, oropharynx, and larynx.
• Patients with at least an ipsilateral neck dissection.
• Patient has at least one pathological feature that is an indication for PORT: positive or close (\<5 mm) margin, presence of LVI or PNI, pT3 or pT4 disease, positive lymph nodes, or ENE.
• Pathologically lymph node negative in at least one dissected hemi-neck or PET-CT

You may not qualify if:

• Patients with bilaterally involved neck nodes
• Patients with pT3-T4 tumors involving midline who undergo an ipsilateral neck dissection (unless a contralateral neck dissection is performed)
• Serious medical comorbidities or other contraindications to radiotherapy
• Prior history of head and neck cancer within 5 years
• Any other active invasive malignancy
• Prior head and neck radiation at any time
• Prior oncologic head and neck surgery in the oral cavity or neck.
• Known metastatic disease
• Locoregional disease recurrence identified following surgical resection but prior to start of radiotherapy
• Inability to attend full course of radiotherapy or follow-up visits 11.Unable or unwilling to complete QoL questionnaires

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

Study Officials

• Tarek Shouman

  National Cancer Institute, Egypt

  STUDY DIRECTOR

Central Study Contacts

Sara A Elsharkawy

CONTACT

+20 2 2368 4423; Sara.elsharkawy@nci.cu.edu.eg

May Ashour

CONTACT

May25s@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 14, 2022
• Study Start: April 15, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-09

Locations

EG (1)