Reducing postoperative radiotherapy for head and neck cancer
A Prospective Phase II Clinical Trial on the Reduction of Postoperative Radiotherapy in Head and Neck Squamous Cell Carcinoma
This study is testing if lowering the radiation dose for patients with late-stage head and neck cancer, who have responded well to surgery and treatment, can help keep the cancer under control while also improving their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06630780 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the control rate and quality of life in patients with late-stage head and neck squamous cell carcinoma (HNSCC) who have achieved a pathological complete response (pCR) after cervical lymph node surgery combined with neoadjuvant chemotherapy and immunotherapy. The researchers will investigate whether reducing the radiation dose can protect normal tissues while maintaining tumor efficacy and minimizing the negative impact of radiotherapy on immunotherapy. This prospective phase II study will involve monitoring participants' outcomes following a modified radiation approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 with pathologically confirmed HNSCC who have undergone neoadjuvant chemotherapy and achieved pCR.
Not a fit: Patients with early-stage HNSCC or those who have not received neoadjuvant chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved quality of life for patients by reducing the side effects of postoperative radiotherapy.
How similar studies have performed: While there have been studies exploring reduced radiation doses in cancer treatment, this specific approach combining immunotherapy and postoperative radiotherapy in HNSCC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preoperative pathologically confirmed initial treatment of head and neck squamous cell carcinoma * Receive neoadjuvant chemotherapy combined with PD-1 monoclonal antibody immunotherapy, and meet one of the following conditions: Preoperative clinical stage was T3-T4 or N2-N3 (AJCC 8th edition). Patients with oral cancer/oropharyngeal cancer had positive lymph nodes in the IV/V region with imaging diagnosis or biopsy confirmation before surgery. HPV/ P16-positive oropharyngeal cancer patients with clinical lymph node invasion (ENE), one positive cervical lymph node \> 3cm or multiple positive cervical lymph nodes before surgery * The pathology of at least one cervical lymph node was determined by pCR； * Karnofsky's physical status score ≥70 points； * Age: 18 \~ 70 years old； * Laboratory examination results within 1 week before enrollment met the following conditions: neutrophils (ANC) ≥1.5×109/L, platelets (PLT) ≥ 75×109/L * Patients participate voluntarily and sign informed consent forms. Exclusion Criteria: * Previous head and neck radiation treatment * Severe complications； * Pregnant or lactating women * Who were deemed unsuitable for inclusion by the researchers.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Chun-Yan Chen
- Email: chenchuny@sysucc.org.cn
- Phone: 020-87342926
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.