Reducing radiation after surgery for advanced oral cancer

A Phase II Clinical Study of Continuous Hyperfractionated Accelerated Radiotherapy(CHART) in Oral Cancer Patients Who Underwent Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR and MPR After Surgery.

This study is testing if giving less radiation after surgery can still help people with advanced oral cancer who responded well to earlier treatments while reducing side effects.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06353685 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of de-escalated postoperative radiotherapy using continuous hyperfractionated accelerated radiotherapy (CHART) for patients with advanced oral squamous cell carcinoma who achieve a pathologic complete response (pCR) or major pathologic response (MPR) after neoadjuvant therapy and surgery. The study aims to determine if reducing the radiation dose and volume can maintain treatment efficacy while minimizing side effects. By focusing on patients with favorable responses to prior treatments, the trial seeks to optimize postoperative care and improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with untreated, histologically confirmed oral cavity carcinoma who have achieved pCR or MPR after neoadjuvant therapy.

Not a fit: Patients who are pregnant, lactating, or have a history of other malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to less intensive radiation treatment for patients, reducing side effects while maintaining effective cancer control.

How similar studies have performed: Other studies have shown promise with de-escalated radiotherapy approaches, but this specific methodology is still being evaluated for its effectiveness.

Eligibility criteria

Inclusion Criteria:

1. Untreated, histologically confirmed oral cavity carcinoma, staging T2-4N0M0 or T1-4N1-3M0, II-IVB, according to the eighth edition of the AJCC staging system.
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 ≤ 80 years.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
7. Life expectancy of more than 6 months.
8. 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.
9. The regimen of neoadjuvant therapy can be determined by the clinician.
10. 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

Guangzhou

• Sun Yat-sen Memorial hospital, Sun Yat-sen University — Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Bi Zhuofei, Dr.

Conditions De-escalated Radiotherapy; Head and Neck Cancer; de-escalated radiotherapy; CHART; head and neck cancer