Postoperative cisplatin with radiation versus radiation 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
This test sees if adding cisplatin chemotherapy to radiation after surgery helps people with intermediate‑risk head and neck squamous cell carcinoma stay cancer‑free longer and live longer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 386 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 7 sites (Guangzhou, Guangdong and 6 other locations) |
| Trial ID | NCT07125755 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial compares postoperative adjuvant concurrent cisplatin chemoradiotherapy with adjuvant radiotherapy alone in patients who have had radical surgery for intermediate‑risk head and neck squamous cell carcinoma. Eligible patients have intermediate‑risk pathological features (for example pT3/pT4, pN2/pN3, certain cervical IV/V nodal involvement for oral cancer, perineural or vascular invasion), no distant metastasis, and adequate organ function and performance status. Participants receive standard postoperative radiotherapy either alone or together with concurrent cisplatin, and outcomes include recurrence, survival, and treatment tolerability. The trial was conducted at Sun Yat‑sen University Cancer Center and an affiliated hospital in China.
Who should consider this trial
Good fit: Adults aged 18–70 who underwent radical surgery for head and neck squamous cell carcinoma, have intermediate‑risk pathological features, no distant metastasis, KPS >70, and adequate blood, liver, and kidney function are the ideal candidates.
Not a fit: Patients with low‑risk disease, distant metastases, poor performance status, significant organ dysfunction, receiving palliative treatment, or outside the 18–70 age range are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If adding cisplatin reduces recurrence or improves survival, it could change postoperative care by identifying intermediate‑risk patients who benefit from combined chemoradiotherapy.
How similar studies have performed: Concurrent cisplatin with postoperative radiotherapy has shown survival benefit in high‑risk head and neck cancers, but its advantage for intermediate‑risk patients has not been clearly established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong and 6 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Affiliated Hospital of Guilin Medical College — Guilin, Guangxi, China (Recruiting)
- Hainan General Hospital — Sanya, Hainan, China (Recruiting)
- Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
- Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Lei Chen Principal Investigator, M.D — Sun Yat-sen University
- Study coordinator: Lei Chen, M.D
- Email: chenlei@sysucc.org.cn
- Phone: +862013570051477
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.