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

Sponsor

National Cancer Institute, Egypt (Other)

Overall Status

Recruiting

CT.gov ID

NCT05650034

Collaborator

(none)

Enrollment

Location

Arm

31.5

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Carcinoma	Radiation: Elective nodal de-escalation arm	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

57 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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).

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

Outcome Measures

Primary Outcome Measures

Regional failure in the omitted/de-escalated elective nodal irradiation site [Baseline to 1 year]

Secondary Outcome Measures

Acute toxicity [Baseline to 6 months]
Late toxicity [Baseline to 1 year]
Overall survival [Baseline to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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