Head and Neck CarcinomaNCT05650034
Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma
A study testing Elective nodal de-escalation arm in people with Head and Neck Carcinoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Head and Neck Carcinoma
- What is being tested?
- Elective nodal de-escalation arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2021to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
May Ashour contact
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo, 11796
Sara Elsharkawy
About this study
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.
Read the 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
- Being tested
- Elective nodal de-escalation arm
- Keywords
- Post operative radiotherapy, Elective nodal irradiation, Head and neck SCC, Elective nodal omission, De-escalation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective nodal de-escalation armRadiation
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).
| Study group | Role | What they receive |
|---|---|---|
| Elective nodal de-escalation arm | Experimental | 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). Receives: Radiation: Elective nodal de-escalation arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional failure in the omitted/de-escalated elective nodal irradiation site
Measured: Baseline to 1 year
Secondary outcomes (3)
Acute toxicity
Measured: Baseline to 6 months
Late toxicity
Measured: Baseline to 1 year
Overall survival
Measured: Baseline to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start15 Apr 2021
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tarek Shouman, Study director, National Cancer Institute, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650034
- Sponsor's protocol ID
- RO2105-30901
- Status last verified
- Sep 2022
- First submitted
- 6 Dec 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Operative Radiotherapy De-Escalation of Negative Nodal Regions in Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05650034
- Acronym / sponsor ID
- RO2105-30901
- Conditions
- Head and Neck Carcinoma
- Keywords
- Post operative radiotherapy, Elective nodal irradiation, Head and neck SCC, Elective nodal omission, De-escalation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective nodal de-escalation arm | Experimental | Radiation: Elective nodal de-escalation armOmission 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). |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elective nodal de-escalation armOmission 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 |
Primary outcome
Regional failure in the omitted/de-escalated elective nodal irradiation site
Time frame: Baseline to 1 year
3 secondary outcomes
Acute toxicity
Time frame: Baseline to 6 months
Late toxicity
Time frame: Baseline to 1 year
Overall survival
Time frame: Baseline to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
May Ashour contact
Tarek Shouman study director
National Cancer Institute, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective nodal de-escalation arm in people with Head and Neck Carcinoma, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara A Elsharkawy (+20 2 2368 4423, Sara.elsharkawy@nci.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional failure in the omitted/de-escalated elective nodal irradiation site (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.