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Response-adapted Postoperative Radiotherapy In Locally Advanced Head and Neck Cancer

ConditionsHead & Neck Squamous Cell CarcinomaLocally Advanced Head and Neck Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFudan University

About this trial

This was a phase II clinical study. Patients with histologically confirmed, resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) without distant metastasis were enrolled. Enrolled patients received three cycles of neoadjuvant immunotherapy combined with chemotherapy. Radical surgery was performed 3-5 weeks after completion of the third neoadjuvant cycle, with the requirement of achieving negative surgical margins (R0 resection). Adjuvant radiotherapy was administered based on postoperative pathological findings.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who have signed the informed consent form and are willing to complete the study according to the protocol;

Age ≥18 years and ≤75 years;

Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN), with the primary tumorlocated in the oropharynx, oral cavity, larynx, or hypopharynx;

Resectable, locally advanced squamous cell carcinoma of the head and neck without distant metastasis (AJCC8th edition: HPV-negative SCCHN: Stage III-IVB; HPV-positive oropharyngeal cancer: T1-4N1-3M0 or T3-4N0M0);

Disqualifiers

Prior or concurrent malignancy (except for malignancies cured with disease-free survival >5 years, such as basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma);

Receipt of any of the following treatments: a. Any investigational drug within 4 weeks prior to the first dose of study drug. b. Concurrent enrollment in another clinical study, except for observational (non-interventional) clinical studies. c. Requirement for systemic corticosteroids at a dose >10 mg/day prednisone equivalent or other immunosuppressive agents within 2 weeks prior to the first dose of study drug, except for corticosteroids used for local inflammation or for prophylaxis of allergy, nausea, and vomiting. Other special circumstances require discussion with the investigator. In the absence of active autoimmune disease, inhaled or topical corticosteroidsand adrenal corticosteroid replacement at doses >10 mg/day prednisone equivalent are permitted. d. Receipt ofantitumor vaccines or live vaccines within 4 weeks prior to the first dose of study drug (for COVID-19 vaccination,an interval of >2 weeks between vaccination and treatment is required). e. Major surgery or severe trauma within 4weeks prior to the first dose of study drug.

Prior radiotherapy to the head and neck region;

Uncontrolled cardiac symptoms or diseases, such as: a. New York Heart Association (NYHA) Class II or higher heart failure; b. Unstable angina; c. Myocardial infarction within 1 year; d. Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard adjuvant radiotherapy based on pathologic findings

    Radiation

    Standard adjuvant radiotherapy based on pathologic findings

  • De-escalated radiotherapy with a reduced dose

    Radiation

    De-escalated radiotherapy: reduce the dose of elective nodal irradiation (ENI).

  • De-escalated radiotherapy with omission of ENI

    Radiation

    De-escalated radiotherapy: omit elective nodal irradiation (ENI).

Treatment groups

85 Participants
are divided into 3 treatment groups
Group A: High-risk GroupActive comparator 1 intervention
Group B: Intermediate-risk GroupExperimental treatment 1 intervention
Group C: Low-risk GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of cervical nodal recurrence

defined as the probability of neck nodal recurrence occurring before local recurrence or distant metastasis, analyzed using a competing risk model.

Time frame
2 year

Secondary outcomes

1

Progression-free survival rate

Progression-free survival, defined as the time from enrollment to the date of first documented objective tumor progression or death from any cause, whichever occurs first. Patients without documented progression or death at the data cutoff date will be censored.

Time frame
2 year
2

Overall survival rate

Overall survival, defined as the time from enrollment to death from any cause. Data for patients who are alive at the time of analysis will be censored at the date last known to be alive.

Time frame
2 year
3

Major pathologic response

Major pathologic response, defined as residual viable tumor cells ≤10% within the surgical tumor bed.

Time frame
6 month
4

Adverse events

An adverse event is any untoward medical occurrence in a clinical trial subject following administration of a medicinal product, which does not necessarily have a causal relationship with the treatment. An AE may be any unfavourable and unintended sign (including abnormal laboratory findings), symptom, or disease.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Hunan Cancer Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: