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Effects of reduced target volume and tumor regression field irradiation dose on survival and quality of life in locally advanced (stage III-IVB) hypopharyngeal cancer patients receiving radiotherapy after induction chemotherapy: a prospective,non-inferiority, randomised controlled trial

Effects of reduced target volume and tumor regression field irradiation dose on survival and quality of life in locally advanced (stage III-IVB) hypopharyngeal cancer patients receiving radiotherapy after induction chemotherapy: a prospective,non-inferiority, randomised controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044159
Enrollment
Unknown
Registered
2021-03-12
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-08-30

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

Conditions

hypopharyngeal carcinoma

Interventions

group A: GTV - P based on induction before primary tumors infiltrating range sketch
CTV-P1: GTV-P was expanded by 1cm and repaired according to the anatomical structure.:don't narrow the high dose target area
group B: GTV - P on the basis of primary focal residual lesions after induction infiltration range sketch)
CTV-P1: GTV-P+1cm (including the retraction part of the tumor after induction), and repaired according to the anatomical structure.:arrow the high dose target area

Sponsors

The First Affiliated Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) 18-70 years old. (2) The pathological type was squamous epithelial carcinoma. (3) ECOG physical condition score: 0~1 points. (4) Patients with stage III-IVB (according to the AJCC staging criteria of the 8th edition) who were newly treated for hypopharyngeal cancer. (5) Normal bone marrow function : white blood cell count > 4 x 10^9/L , hemoglobin >90 g/L and platelet count > 100 x 10^9/L . (6) Normal liver and kidney function: total bilirubin = 60 mL /min.

Exclusion criteria

Exclusion criteria: (1) The pathological type was non-squamous cell carcinoma. (2) A prior history of malignancy, except for adequately treated basal cell carcinoma or squamous cell carcinoma and cervical carcinoma in situ. (3) Pregnant or lactating women (pregnancy tests should be considered for women of childbearing age; Emphasis should be placed on effective contraception during treatment. (4) Previous radiation therapy (except for skin cancer that is not melanoma and is outside the target area of radiation therapy). (5) The primary and cervical metastases received chemotherapy or surgical treatment (except for diagnostic treatment). (6) With other serious diseases, which may pose a greater risk or affect trial compliance. Examples: unstable heart disease requiring treatment, kidney disease, chronic hepatitis, poorly controlled diabetes (fasting glucose > 1.5 x ULN), and mental illness.

Design outcomes

Primary

MeasureTime frame
LRFS;

Countries

China

Contacts

Public ContactQiao Qiao

The First Affiliated Hospital of China Medical University

braveheart8063@outlook.com+86 13889368446

Outcome results

None listed

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