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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05650034
• Other study ID #: RO2105-30901
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2021
• Est. completion date: December 2023

Study information

• Verified date: September 2022
• Source: National Cancer Institute, Egypt
• Contact: Sara A Elsharkawy
• Phone: +20 2 2368 4423
• Email: Sara.elsharkawy[@]nci.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

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).

Locations

Country	Name	City	State
Egypt	National Cancer Institute	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional failure in the omitted/de-escalated elective nodal irradiation site		Baseline to 1 year
Secondary	Acute toxicity		Baseline to 6 months
Secondary	Late toxicity		Baseline to 1 year
Secondary	Overall survival		Baseline to 2 years