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NCT Number: NCT06630780

Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

In order to understand whether it can better protect normal tissues such as pharyngeal constriction muscles, thyroid, parotid glands, and submandibular glands without affecting the efficacy of tumors, and reduce the negative impact of radiotherapy on immunotherapy, the investigators plan to conduct a prospective phase II study to explore the control rate and quality of life of patients with late head and neck squamous cell carcinoma who have obtained postoperative pCR after cervical lymph node surgery with neoadjuvant chemotherapy combined with immunotherapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Age: 18 ~ 70 years old;
  • Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L
  • Patients participate voluntarily and sign informed consent forms.

Exclusion criteria

  • Previous head and neck radiation treatment
  • Severe complications;
  • Pregnant or lactating women
  • Who were deemed unsuitable for inclusion by the researchers.

Treatment and study plan

Head and Neck Cancers

Radiation

All 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.

Primary outcomes

  1. 2-year region-free recurrence survival (RRFS)

    Time frame: 2-year

    Time to confirmed diagnosis of documented recurrence of cervical lymph nodes or death from any cause

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 2-year

    Defined as documented treatment progression or death from any cause.

  2. Distant metastasis-free survival (DMFS)

    Time frame: 2-year

    Defined as documented distant metastases or death from any cause

  3. Overall survival (OS)

    Time frame: 2-year

    Defined as a documented death due to any cause or last follow-up; regional recurrence pattern; and acute and late toxicity.

  4. Local recurrence-free survival (LRFS)

    Time frame: 2-year

    Defined as documented primary tumor recurrence or death from any cause

  5. Acute and Late Radiation Injuries

    Time frame: Day 1 of radiotherapy to 2 years post-treatment

    The acute radiation toxicity was assessed using the CTCAE 5.0 version, while the RTOG and EORTC late radiation toxicity scales were used to evaluate late toxicity.

  6. Quality of life assessment

    Time frame: Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.

    The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for the Head and Neck Cancer Module (QLQ-H&N35) version 1.0.

  7. Quality of life assessment

    Time frame: Baseline, during radiotherapy, at the end of radiotherapy, 3 months after the end of radiotherapy, 6 months after the end of radiotherapy, and thereafter according to routine follow-up until 2 years.

    The Quality of Life (QoL) was assessed at baseline and during follow-up using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30).

Study contacts

Contact information is provided by the study sponsor or research team.

Chun-Yan Chen

CONTACT

[email protected]

020-87342926 ext. 86

Ya-Ni Zhang

CONTACT

[email protected]

020-87342926 ext. 86

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma

Acronym: REPORT-HNSCC

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 8, 2024
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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