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Head and Neck Cancer Squamous Cell CarcinomaHNSCCNCT06768125

Hypofractionated Radiotherapy for HNSCC in Elderly Patients

A study testing Hypofractionated Radiation Therapy in people with Head and Neck Cancer Squamous Cell Carcinoma and ELDERLY PEOPLE, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Hypofractionated Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
1 Jan 2024to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • Previously undergone radiotherapy for head and neck cancer;
  • 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;
  • 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.;
  • Subjects with any active infection or unexplained fever > 38.5°C occurring during the screening period or before the first dose;
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  • 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%;
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

Other trials in China

About this study

Official title: Hypofractionated Radiotherapy for Squamous Cell Carcinoma of the Head and Neck in Elderly Patients: A Prospective Phase II Clinical Study

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.

Read the detailed description

This study aims to conduct a prospective study to evaluate the efficacy and safety of segmented hypofractionated radiotherapy in elderly patients with head and neck squamous cell carcinoma and to explore a radiotherapy fractionation scheme suitable for elderly HNSCC patients in China.

Being tested
Hypofractionated Radiation Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypofractionated Radiation TherapyRadiation

    95% PGTVp: 33 Gy in 3.3 Gy per session for 10 sessions, and 95% PTV1: 25 Gy in 1.5 Gy per session for 10 sessions, with an interval of 1-2 weeks, for a total of 2 cycles.

Study groups in NCT06768125
Study groupRoleWhat they receive
hypofractionated radiationExperimentalThe hypofractionated radiotherapy regimen specified in this study is as follows: Radiotherapy: The positioning is referenced from the guidelines of the Radiation Oncology Department of the Chinese Academy of Medical Sciences Cancer Hospital. The specific contouring and target area definitions are provided in the main text. The recommended radiation doses and fractionation methods are: 95% PGTVp: 33 Gy in 3.3 Gy per session for 10 sessions, and 95% PTV1: 25 Gy in 1.5 Gy per session for 10 sessions, with an interval of 1-2 weeks, for a total of 2 cycles.
Receives: Radiation: Hypofractionated Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-Free Survival, is defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first after 6 months of treatment.

    Measured: 6 months

Secondary outcomes (4)

  1. LRC

    Local Regional Control, is defined as the time from random assignment to documented local or regional relapse, whichever occurred first.

    Measured: 18 months

  2. OS

    Overall Survival, is defined as the time from random assignment to death from any cause or censored at the date of last follow-up.

    Measured: 18 months

  3. DMFS

    Distant-Metastasis Free Survival, is defined as the time from random assignment to distant metastasis, or death from any cause, whichever occurred first.

    Measured: 18 months

  4. PFS

    Progression-Free Survival, is defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2025
  2. Study start1 Jan 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06768125
Sponsor's protocol ID
NCC4265
Acronym
HNSCC
Status last verified
Jan 2025
First submitted
29 Dec 2024
Last updated
10 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: only if researchers asked by email

Questions about this trial

What is this clinical trial studying?

A study testing Hypofractionated Radiation Therapy in people with Head and Neck Cancer Squamous Cell Carcinoma and ELDERLY PEOPLE, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06768125.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.

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