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Tests treatment safety and results for Head and Neck Squamous Cell Carcinoma
Official title The Efficacy and Safety of De-escalated Postoperative Radiotherapy in Locally Advanced HNSCC With pCR/MPR
ClinicalTrials.gov ID: NCT05854823
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Untreated, histologically confirmed head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx), staging T3-4N0M0 or...
- Pathological evaluation of surgical specimens was pCR (pathologic complete response, no viable tumor cells) or MPR (Major pathologic response...
- Negative surgical margin.
- No extranodal extension.
- Aged ≥ 18 years and ≤ 70 years.
You likely can't join if
- Pregnant or lactating women.
- 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...
- Neoadjuvant therapy or radical surgery was not completed.
- Recurrence or distant metastasis occurred before postoperative radiotherapy.
- There are contraindications for radiotherapy, chemotherapy, immunotherapy and targeted therapy.
- Uncontrolled cardiac clinical symptoms or diseases.
See the full eligibility criteria
- 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...
- Pathological evaluation of surgical specimens was pCR (pathologic complete response, no viable tumor cells) or MPR (Major pathologic response, residual viable tumor cells≤10%).
- Negative surgical margin.
- No extranodal extension.
- Aged ≥ 18 years and ≤ 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Life expectancy of more than 6 months.
- 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):
- Hemoglobin ≥ 75 g/L; absolute neutrophil count ≥ 1.5 × 10\^9/L; and platelet count ≥ 100 × 10\^9/L;
- Serum albumin ≥ 25 g/L;
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN;
- Serum creatinine ≤ 1.5 × ULN;
- 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...
- 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.
- The regimen of neoadjuvant therapy can be determined by the clinician.
- people voluntarily join the study and sign an informed consent form, with good compliance.
- Pregnant or lactating women.
- 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.
- Neoadjuvant therapy or radical surgery was not completed.
- Recurrence or distant metastasis occurred before postoperative radiotherapy.
- There are contraindications for radiotherapy, chemotherapy, immunotherapy and targeted therapy.
- Uncontrolled cardiac clinical symptoms or diseases.
- Serious infections.
- A history of immunodeficiency, including HIV-positive status or other acquired congenital immunodeficiency diseases, or a history of organ transplantation and bone marrow transplantation.
- 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...
- 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).
- Known history of psychotropic drug abuse, alcoholism and drug use.
- Not suitable for inclusion, as judged by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhuhai, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhuhai, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.