NCT06768125Enrolling by invitation
Hypofractionated Radiotherapy for HNSCC in Elderly Patients
Hypofractionated Radiotherapy for Squamous Cell Carcinoma of the Head and Neck in Elderly Patients: A Prospective Phase II Clinical Study
Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Head and neck squamous cell carcinoma (HNSCC) is a common malignant tumor, with 25% of HNSCC patients diagnosed at over 70 years of age. As the population ages, it is expected that by 2030, this proportion will exceed 60%. Elderly patients are gradually becoming the main population among head and neck cancer patients. Older patients often have a lower desire to seek medical treatment, leading to a higher number of late-stage diagnoses. Additionally, with declining physical function and multiple comorbidities, frequent hospital visits can be inconvenient, making them often unsuitable for aggressive surgery or comprehensive treatment. In clinical practice, the commonly used conventional fractionated radiotherapy (66-70 Gy in 1.8-2.2 Gy per session over 30-33 sessions, completed in 6-7 weeks) is a time-consuming and intensive treatment method, often resulting in significant and prolonged acute and late toxicities. Hypofractionated radiotherapy (HFRT) significantly reduces the number of treatment sessions and shortens the treatment duration compared to conventional fractionation. Additionally, delivering higher doses can quickly and effectively reduce tumor burden by increasing the lethality to tumor cells. Currently, there are few reports on HFRT for head and neck cancer patients abroad, and no reports on this treatment regimen for elderly HNSCC patients in China. In preliminary studies, our research group utilized a segmented hypofractionated regimen (66 Gy in 3.3 Gy per session for 20 sessions, treated for 2 weeks, followed by 1 week of rest, and then treated for another 2 weeks) to treat 12 HNSCC patients aged 77 to 97 years. The recent effective rate was 100%, with good treatment tolerance and no severe toxic reactions observed.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- First submitted
- 29 Dec 2024
- Start date
- 1 Jan 2024
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Diseases
- Head and neck cancer
- NCT number
- NCT06768125
What you commit to
- Study type: Interventional
- Planned participants: 51
- From 1 Jan 2024 to the primary completion date, 30 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously undergone radiotherapy for head and neck cancer;
- Concurrent other antitumor therapies;
- Neoadjuvant therapy;
- Subjects who have experienced a severe infection within one month before enrollment, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
Other illness
- Squamous cell carcinoma of other primary sites in the head and neck, such as paranasal sinuses, nasopharynx, glottic laryngeal cancer, skin, or salivary gland tissues;
- Subjects with any active infection or unexplained fever \> 38.5°C occurring during the screening period or before the first dose;
- History of other malignancies within the past five years (except for completely treated in situ cervical cancer or basal cell carcinoma or squamous cell carcinoma of the skin);
- History of substance abuse involving psychiatric drugs that cannot be discontinued or presence of mental disorders.
Lab values
- Presence of severe cardiovascular diseases: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA Class III-IV heart failure (according to the New York Heart Association classification, see Appendix 3), or echocardiogram indicating left ventricular ejection fraction (LVEF) \< 50%;
Who the study is looking for
- Age ≥ 65 years;
- Patients with histologically or cytologically confirmed stage II-IVA head and neck squamous cell carcinoma (AJCC 8th edition), including oral cavity, oropharynx, hypopharynx, larynx, and cervical metastatic squamous carcinoma of unknown primary;
- At least one measurable lesion;
- No prior systemic antitumor treatment or locoregional therapy for head and neck squamous cell carcinoma;
- ECOG performance status of 1-3;
- Expected survival time of ≥ 3 months;
- Patients assessed by the physician as unsuitable for surgical treatment and not candidates for radical radiotherapy;
- Functional status of vital organs compatible with daily basic activities (excluding any blood components or cell growth factors within 14 days): adequate bone marrow reserve function: white blood cells (WBC) ≥ 2.0 × 10\^9/L, neutrophil count (NEUT) ≥ 1.0 × 10\^9/L, platelet count (PLT) ≥ 80 × 10\^9/L, hemoglobin (Hb) ≥ 90 g/L;
- Able and willing to comply with the study and follow-up procedures;
- The subject voluntarily agrees to participate in this clinical study and signs the informed consent form, demonstrating good compliance and ability to cooperate with follow-up.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital, Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.