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A randomized clinical study of diffusion weighted magnetic resonance imaging guided dose painting intensity modulated radiotherapy in locally advanced head and neck squamous cell carcinoma

A randomized clinical study of diffusion weighted magnetic resonance imaging guided dose painting intensity modulated radiotherapy in locally advanced head and neck squamous cell carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077064
Enrollment
Unknown
Registered
2023-10-27
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

head and neck squamous cell carcinoma

Interventions

DWI guided DP-RT group (DWI group):The target volume GTV-DWI is defined as the area <ADC mean within the GTV. Radiation dose to GTV-DWI is escalated to 77Gy, and the fractional dose is escalated to 2.
Anatomic imaging group (control group):The standard radiotherapy dose of 70.0Gy was given to the target volume PGTV, with a fractional dose of 2.0Gy/F.

Sponsors

Hu'nan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Locally advanced squamous cell carcinoma of the head and neck (oral, oropharyngeal, hypopharyngeal, laryngeal) confirmed by pathology or histology, except nasopharyngeal; age between 18 and 75 years; normal function of major organs, that is, blood routine and biochemical tests meet standards; a Karnofsky performance status score of at least 70; have no history of previous RT; no severe organ dysfunction ; the patient and their family have informed consent.

Exclusion criteria

Exclusion criteria: A history of previous RT, secondary malignancy, surgery, evidence of distant metastasis, presence of uncontrolled life-threatening illness, or pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
disease-free survival;

Secondary

MeasureTime frame
local recurrence-free survival;regional recurrence-free survival;locoregional recurrence-free survival;distant metastasis-free survival;overall survival;

Countries

China

Contacts

Public ContactLiu Feng

Hu'nan Cancer Hospital

liufeng820111@163.com+86 186 1398 5727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026