Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05854823

The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR

Led by Fifth Affiliated Hospital, Sun Yat-Sen University · Updated on 2023-05-11

23

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. The eligible patients are scheduled to administered postoperative radiotherapy, PTV 50Gy/25F, instead of the standard dose of 60Gy. The overall primary study hypothesis is that reducing the dose of postoperative radiotherapy in the specific population does not affect DFS but significantly reduces treatment related adverse events.

CONDITIONS

Official Title

The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, within 6 weeks after neoadjuvant therapy and radical surgery
  • Pathological complete response (no viable tumor cells) or major pathological response (residual viable tumor cells 6410%) in surgical specimens
  • Negative surgical margin
  • No extranodal extension
  • Aged 18 to 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy of more than 6 months
  • Adequate organ function with specified blood counts and liver, kidney, and clotting parameters
  • Women of childbearing age agree to use contraception during treatment and for 3 months after
  • Neoadjuvant therapy regimen determined by clinician
  • Voluntary participation with signed informed consent and good compliance
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • History of other malignant tumors within 5 years except certain cured skin and cervical cancers and thyroid papilloma
  • Incomplete neoadjuvant therapy or radical surgery
  • Recurrence or distant metastasis before postoperative radiotherapy
  • Contraindications for radiotherapy, chemotherapy, immunotherapy, or targeted therapy
  • Uncontrolled cardiac symptoms or diseases
  • Serious infections
  • History of immunodeficiency or organ/bone marrow transplantation
  • Active tuberculosis infection or history within 1 year without formal treatment
  • Active hepatitis B or C infection
  • History of psychotropic drug abuse, alcoholism, or drug use
  • Not suitable for inclusion as judged by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China, 519000

Actively Recruiting

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Research Team

Y

Yingpeng Peng, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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