Reduced postoperative radiotherapy for advanced head and neck cancer

De-escalation of Postoperative Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma With Pathological Complete Response/Major Pathological Response: A Single-arm, Prospective Phase II Clinical Study

This study is testing if giving a lower dose of radiation after surgery can help people with advanced head and neck cancer stay cancer-free while causing fewer side effects.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Zhuhai, Guangdong)
• Trial ID: NCT05854823 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the efficacy and safety of a reduced dose of postoperative radiotherapy in patients with locally advanced head and neck squamous cell carcinoma who have achieved a pathological complete response or major pathological response after neoadjuvant therapy. Eligible participants will receive a dose of 50Gy over 25 fractions instead of the standard 60Gy. The primary hypothesis is that this de-escalation will not negatively impact disease-free survival while significantly reducing treatment-related adverse events.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with specific stages of head and neck squamous cell carcinoma who have shown a strong response to prior treatment.

Not a fit: Patients with less advanced disease or those who do not meet the criteria for pathological response may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could minimize side effects for patients while maintaining effective cancer control.

How similar studies have performed: While similar approaches have been explored, this specific de-escalation strategy in this patient population is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or T1-4N1-3M0, III-IVB, according to the eighth edition of the AJCC staging system; within 6 weeks after receiving neoadjuvant therapy and radical surgery.
2. Pathological evaluation of surgical specimens was pCR (pathologic complete response, no viable tumor cells) or MPR (Major pathologic response, residual viable tumor cells≤10%).
3. Negative surgical margin.
4. No extranodal extension.
5. Aged ≥ 18 years and ≤ 70 years.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
7. Life expectancy of more than 6 months.
8. Adequate organ function, based on meeting all of the following criteria (no blood components and cytologic growth factors were received within 14 days prior to the test):

   1. Hemoglobin ≥ 75 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; and platelet count ≥ 100 × 10\^9/L;
   2. Serum albumin ≥ 25 g/L;
   3. Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN;
   4. Serum creatinine ≤ 1.5 × ULN;
   5. Activated partial clotting enzyme time and international standardized ratio (INR) ≤ 1.5 × ULN (Patients on stable doses of anticoagulant therapy such as low molecular weight heparin or warfarin with INR within the expected treatment range of anticoagulants can be screened ).
9. Women of childbearing age should agree to the use of contraception (e.g., intrauterine devices, birth control pills, or condoms) during treatment and for 3 months thereafter.
10. The regimen of neoadjuvant therapy can be determined by the clinician.
11. Subjects voluntarily join the study and sign an informed consent form, with good compliance.

Exclusion Criteria:

1. Pregnant or lactating women.
2. A history of other malignant tumors within the previous 5 years or at the time of enrollment, except for cured skin basal cell carcinoma and cervical in situ cancer, as well as thyroid papilloma.
3. Neoadjuvant therapy or radical surgery was not completed.
4. Recurrence or distant metastasis occurred before postoperative radiotherapy.
5. There are contraindications for radiotherapy, chemotherapy, immunotherapy and targeted therapy.
6. Uncontrolled cardiac clinical symptoms or diseases.
7. Serious infections.
8. A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
9. Patients with active tuberculosis infection found by history or CT examination, or patients with active tuberculosis infection history within 1 year prior to enrollment, or patients with active tuberculosis infection history before 1 year without formal treatment.
10. Active hepatitis B (HBV DNA ≥ 2,000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody test and HCV RNA above the lower limit of detection).
11. Known history of psychotropic drug abuse, alcoholism and drug use.
12. Not suitable for inclusion, as judged by the investigator.

Where this trial is running

Zhuhai, Guangdong

• Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yingpeng Peng, Dr.

Conditions Head and Neck Squamous Cell Carcinoma; pathological complete response; major pathological response