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NCT07125755RecruitingPhase 3

Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma

A Prospective, Multicenter, Randomized Controlled Phase 3 Clinical Trial Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma

Source: ClinicalTrials.gov · Last updated 23 Mar 2026

Brief summary (registry, in English)

The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
386 (estimated)
First submitted
10 Aug 2025
Start date
15 Aug 2025
Primary completion date
15 Aug 2028
Lead sponsor
Sun Yat-sen University
NCT number
NCT07125755

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 386
  • From 15 Aug 2025 to the primary completion date, 15 Aug 2028
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous chemotherapy (except induction chemotherapy prior to surgery).
  • Previous radiation therapy.

Other illness

  • Previous history of malignant tumor.
  • With other serious medical conditions that may pose a greater risk or affect compliance with the test. Examples include:
  • unstable heart disease that requires treatment
  • kidney disease
  • chronic hepatitis
  • mental illness.

Lab values

  • poorly controlled diabetes (fasting blood glucose \> 1.5×ULN)

Age

  • Age \>70 years or \<18 years.

Other

  • Treatment is palliative.
  • Women who are pregnant or breastfeeding

Who the study is looking for

  • The pathological type is head and neck squamous cell carcinoma
  • Stages
  • Radical surgery has been performed, and there are intermediary-risk factors (pT3/pT4, pN2/pN3, positive lymph nodes in the cervical IV/V region of oral cancer, nerve invasion, and vascular invasion).
  • No evidence of distant metastasis (M0).
  • Functional status: Karnofsky scale (KPS) \> 70.
  • Normal bone marrow function:
  • white blood cell count \> 4×109/L
  • hemoglobin \> 120g/L in males, 110g/L in females
  • platelet count \> 100×109/L
  • Normal liver function:
  • alanine aminotransferase (ALT), aspartate aminotransferase (AST) \< 1.5 times the upper limit of normal (ULN)
  • alkaline phosphatase (ALP) \< 2.5×ULN
  • bilirubin \< ULN.
  • Normal renal function: creatinine clearance \> 60 ml/min.
  • Patients must be informed of the basic contents of this study and sign informed consent.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Xiangya Hospital Central South University
Coordinator of this site? Confirm its status
ChangshaChinaRecruiting
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaRecruiting
Affiliated Hospital of Guilin Medical College
Coordinator of this site? Confirm its status
GuilinChinaRecruiting
Jiangsu Cancer Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Hainan General Hospital
Coordinator of this site? Confirm its status
SanyaChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.