NCT07125755 Comparing Postoperative Adjuvant Cisplatin Concurrent Chemoradiotherapy With Adjuvant Radiotherapy Alone for Intermediate-risk Head and Neck Squamous Cell Carcinoma
| NCT ID | NCT07125755 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Squamous Cell Cancer of Head and Neck (SCCHN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 386 participants |
| Start Date | 2025-08-15 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 386 participants in total. It began in 2025-08-15 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main objective of this trial was to determine the value of concurrent chemoradiotherapy for Intermediate-risk head and neck squamous cell carcinoma
Eligibility Criteria
Inclusion Criteria: A. The pathological type is head and neck squamous cell carcinoma * Stages B. 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). C. No evidence of distant metastasis (M0). D. Functional status: Karnofsky scale (KPS) \> 70. E. 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 G. 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. H. Normal renal function: creatinine clearance \> 60 ml/min. I. Patients must be informed of the basic contents of this study and sign informed consent. Exclusion Criteria: A. Age \>70 years or \<18 years. B. Treatment is palliative. C. Previous chemotherapy (except induction chemotherapy prior to surgery). D. Previous radiation therapy. E. Women who are pregnant or breastfeeding F. Previous history of malignant tumor. G. 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 * poorly controlled diabetes (fasting blood glucose \> 1.5×ULN) * mental illness.
Contact & Investigator
Lei Chen Principal Investigator, M.D
PRINCIPAL INVESTIGATOR
Sun Yat-sen University
Frequently Asked Questions
Who can join the NCT07125755 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Squamous Cell Cancer of Head and Neck (SCCHN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07125755 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 386 participants.
Is NCT07125755 currently recruiting?
Yes, NCT07125755 is actively recruiting participants. Contact the research team at chenlei@sysucc.org.cn for enrollment information.
Where is the NCT07125755 trial being conducted?
This trial is being conducted at Guangzhou, China, Guangzhou, China, Guilin, China, Sanya, China and 3 additional locations.
Who is sponsoring the NCT07125755 clinical trial?
NCT07125755 is sponsored by Sun Yat-sen University. The principal investigator is Lei Chen Principal Investigator, M.D at Sun Yat-sen University. The trial plans to enroll 386 participants.
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