Clinical trial NCT05650034: Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma
Official title: Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Carcinoma
Keywords: Post operative radiotherapy
Elective nodal irradiation
Head and neck SCC
Elective nodal omission
De-escalation
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Regional failure in the omitted/de-escalated elective nodal irradiation site
timeFrame: Baseline to 1 year
Secondary outcomes:
measure: Acute toxicity
timeFrame: Baseline to 6 months
measure: Late toxicity
timeFrame: Baseline to 1 year
measure: Overall survival
timeFrame: Baseline to 2 years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute, Egypt
name: Tarek Shouman
role: STUDY_DIRECTOR
References: