The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR

Trial Title: The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR

NCT ID: NCT05854823

Condition: Head and Neck Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
pathological complete response
major pathological response

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: dose-reduced radiotherapy
Description: Patients receive 50Gy/25F, 2Gy/F QD, five days a week for 5 weeks
Arm group label: de-escalation radiotherapy

Summary: This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of de-escalation of postoperative radiotherapy in locally advanced head and neck squamous cell carcinoma with pathological complete response/major pathological response to neoadjuvant therapy. The eligible patients are scheduled to administered postoperative radiotherapy, PTV 50Gy/25F, instead of the standard dose of 60Gy. The overall primary study hypothesis is that reducing the dose of postoperative radiotherapy in the specific population does not affect DFS but significantly reduces treatment related adverse events.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fifth Affiliated Hospital of Sun Yat-sen University

Address:
City: Zhuhai
Zip: 519000
Country: China

Status: Recruiting

Contact:
Last name: Yingpeng Peng, Dr.

Phone: 07562526191
Email: pengyp3@outlook.com

Start date: April 10, 2023

Completion date: April 9, 2027

Lead sponsor:
Agency: Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class: Other

Source: Fifth Affiliated Hospital, Sun Yat-Sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05854823