Cisplatin chemotherapy with radiotherapy for high-risk head and neck cancer after surgery
A Multicenter, Randomized Controlled, Non-inferior Phase 3 Clinical Trial of 2 Courses of Concurrent Cisplatin Chemoradiotherapy Versus 3 Courses After Surgery for High-risk Head and Neck Squamous Cell Carcinoma
PHASE3 · Sun Yat-sen University · NCT06492460
This study tests whether giving two rounds of cisplatin chemotherapy along with radiation after surgery can help people with high-risk head and neck cancer live longer without their cancer coming back compared to three rounds of chemotherapy.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 422 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Guangzhou, Guangdong and 4 other locations) |
| Trial ID | NCT06492460 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of two courses of cisplatin chemotherapy given concurrently with adjuvant radiotherapy in patients who have undergone surgery for high-risk head and neck squamous cell carcinoma. The primary goal is to determine if the three-year failure-free survival rate is at least 10% better with this regimen compared to three courses of chemotherapy. The study also assesses the efficacy and toxicity of the two-course regimen compared to the three-course regimen during intensity-modulated radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with stages III and IV head and neck squamous cell carcinoma who have undergone radical surgery and have high-risk factors.
Not a fit: Patients over 70 years old or those with distant metastasis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates for patients with high-risk head and neck cancer after surgery.
How similar studies have performed: Previous studies have shown promising results with concurrent chemoradiotherapy approaches, making this a potentially effective strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: A. The pathological type is head and neck squamous cell carcinoma * Stages III and IV B. Radical surgery has been performed with high risk factors (one of below) * extracapsular invasion of cervical metastatic lymph nodes * positive incisional margin or inadequate incisional margin safety distance 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 4 other locations
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
- Affiliated Hospital of Guilin Medical College — Guilin, Guangxi, China (NOT_YET_RECRUITING)
- Hunan Cancer Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
- Xiangya Hospital, Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Lei Chen, 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.
Conditions: Squamous Cell Carcinoma of Head and Neck, Concurrent chemoradiotherapy, Cisplatin, postoperative head and neck squamous cell carcinoma