Reducing radiation after surgery for advanced oral cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Bi Zhuofei, Dr.
• Email: bizhf@mail.sysu.edu.cn
• Phone: 13632301621

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.