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

NCT ID: NCT05650034

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2023-12-31

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.

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.

Conditions

Head and Neck Carcinoma

Keywords

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

Study Design

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

Study Groups

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).

Group Type: EXPERIMENTAL

Elective nodal de-escalation arm

Intervention Type: 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).

Interventions

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).

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek Shouman

Role: STUDY_DIRECTOR

National Cancer Institute, Egypt

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sara A Elsharkawy

Role: CONTACT

Phone: +20 2 2368 4423

Email: Sara.elsharkawy@nci.cu.edu.eg

May Ashour

Role: CONTACT

Email: May25s@hotmail.com

Facility Contacts

Sara Elsharkawy

Role: primary

Other Identifiers

RO2105-30901

Identifier Type: -

Identifier Source: org_study_id