Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
To explore the control rate and quality of life of participants with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy, and the cervical lymph node removal prophylactic irradiation ENI in the low-risk area.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma
Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node > 3cm or multiple positive cervical lymph nodes before surgery
The pathology of at least one cervical lymph node was determined by pCR；
Karnofsky's physical status score ≥70 points；
Disqualifiers
Previous head and neck radiation treatment
Severe complications；
Pregnant or lactating women
Who were deemed unsuitable for inclusion by the researchers.
Trial design
Design model
Single group
Treatments tested in this trial
Head and Neck Cancers
RadiationAll patients received intensity-modulated conformal radiotherapy (IMRT). To ensure study quality, all IMRT plans were reviewed by the research team at Sun Yat-sen University Cancer Center. The delineation principles for the radiotherapy target volume of the primary tumor bed and normal tissues followed the consensus guidelines.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Trial GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
2-year region-free recurrence survival (RRFS)
Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause
Time frame
2-yearSecondary outcomes
1
Progression-free survival (PFS)
Defined as documented treatment progression or death from any cause.
Time frame
2-year2
Distant metastasis-free survival (DMFS)
Defined as documented distant metastases or death from any cause
Time frame
2-year3
Overall survival (OS)
Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity.
Time frame
2-year4
Local recurrence-free survival (LRFS)
Defined as documented primary tumor recurrence or death from any cause
Time frame
2-yearSponsors and contacts
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Source ClinicalTrials.gov