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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05854823
• Other study ID #: ZDWY.TJBZLK.002
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: April 9, 2027

Study information

• Verified date: May 2023
• Source: Fifth Affiliated Hospital, Sun Yat-Sen University
• Contact: Yingpeng Peng, Dr.
• Phone: 07562526191
• Email: pengyp3[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: April 9, 2027
• Est. primary completion date: April 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Radiation:
• dose-reduced radiotherapy
Patients receive 50Gy/25F, 2Gy/F QD, five days a week for 5 weeks

Locations

Country	Name	City	State
China	Fifth Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fifth Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival (DFS)	2-year disease free survival rate	from the first day of treatment to the follow up of 2 years
Secondary	Overall Survival (OS)	2-year overall survival rate	from the first day of treatment to the follow up of 2 years
Secondary	Local Relapse Free Survival (LRFS)	2-year local relapse free survival rate	from the first day of treatment to the follow up of 2 years
Secondary	Distant Metastasis Free Survival (DMFS)	2-year distant metastasis free survival rate	from the first day of treatment to the follow up of 2 years
Secondary	EORTC QLQ-C30	Quality of life evaluation	from 1 week before treatment to the follow up of 2 years
Secondary	EORTC HN35	Quality of life evaluation	from 1 week before treatment to the follow up of 2 years
Secondary	RTOG/EORTC late radiation morbidity scoring scheme	Toxicity criteria of RTOG/EORTC	from 1 week before treatment to the follow up of 2 years