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A randomized controlled trial of different surgical margins in patients with locally advanced hypopharyngeal carcinoma achieving partial remission after neoadjuvant therapy

A randomized controlled trial of different surgical margins in patients with locally advanced hypopharyngeal carcinoma achieving partial remission after neoadjuvant therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089403
Enrollment
Unknown
Registered
2024-09-09
Start date
2024-09-20
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Hypopharyngeal carcinoma

Interventions

Standard surgical margin group:The shortest surgical margin around the primary lesion in hypopharyngeal carcinoma surgery is = 5 mm and < 10 mm.
Extended surgical margin group:The shortest surgical margin around the primary lesion in hypopharyngeal carcinoma surgery is = 10 mm.

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Have signed the research informed consent form and voluntarily joined this clinical study; 2. Age: 20-80 years old; 3. Pathologically diagnosed with hypopharyngeal carcinoma; 4. Patients with surgically resectable T1-T2 hypopharyngeal carcinoma; 5. Preoperatively acceptable to receive neoadjuvant therapy (chemotherapy, targeted therapy, immunotherapy, and/or radiation therapy) achieving partial remission, but not achieving complete remission (CR).

Exclusion criteria

Exclusion criteria: 1. History of concurrent malignant tumors in other locations (except for papillary thyroid cancer or other early tumors with good treatment results); 2. Preoperative radical treatment for recurrent patients; 3. Poor compliance, unwilling to cooperate with the treatment, or resistant to changes in the treatment plan; 4. Lack of complete clinical information and complete follow-up; 5. Other reasons unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
Disease-free survival;Cancer-specific survival;Overall survival;Treatment of hypopharyngeal carcinoma surgery and skin flap reconstruction;Larynx preservation rate after operation;Preoperative treatment;Progression-free survival;Postoperative quality of life;

Secondary

MeasureTime frame
Degree of swallowing function postoperatively;Degree of speech function postoperatively;Postoperation pain;Postoperation treatment;Treatment cost;

Countries

China

Contacts

Public ContactChengzhi Xu

Eye & ENT Hospital of Fudan University

xczmed@126.com+86 180 4980 0608

Outcome results

None listed

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