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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Carcinoma
• Intervention / Treatment: Radiation: Elective nodal de-escalation arm

Detailed Description

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

57 head and neck squamous cell carcinoma cases eligible for post-operative radiotherapy will be recruited and managed according to tumor laterality, nodal status, and laterality of nodal dissection (ipsilateral/ bilateral nodal dissection).

Ipsilateral nodal dissection:

• If ipsilateral N0, bilateral nodal irradiation will be omitted.
• If ipsilateral N positive and tumor was well lateralized, contralateral nodal negativity will be assessed by PETCT. IF PETCT is free, the ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be omitted.
• If ipsilateral N positive and tumor was not well lateralized, ipsilateral nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
• Cases with PETCT positive for malignancy will be excluded from the study.

Bilateral nodal dissection:

• If bilateral N0, bilateral nodal irradiation will be omitted.

• If one sided N positive, laterality of the tumor will be assessed:

  • In well lateralized tumors, the positive side nodal regions will be irradiated while the contralateral nodal irradiation will be omitted.
  • In midline/ non lateralized tumor the positive side nodal regions will be irradiated with conventional doses while the contralateral nodal irradiation will be de-escalated to 40 Gy dose equivalent.
• If bilateral N positive, cases will be excluded from the study.

• Study Type: Interventional
• Enrollment (Anticipated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara A Elsharkawy; Phone Number: +20 2 2368 4423; Email: Sara.elsharkawy@nci.cu.edu.eg
• Study Contact Backup: Name: May Ashour; Email: may25s@hotmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11796
    • Recruiting
    • National Cancer Institute
    • Contact: Sara Elsharkawy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elective nodal de-escalation arm; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Regional failure in the omitted/de-escalated elective nodal irradiation site	Baseline to 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Acute toxicity	Baseline to 6 months
Late toxicity	Baseline to 1 year
Overall survival	Baseline to 2 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Study Director: Tarek Shouman, National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: De-escalation; Post operative radiotherapy; Elective nodal irradiation; Head and neck SCC; Elective nodal omission
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: RO2105-30901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No