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Effectiveness of endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma: a prospective,observational, single-arm clinical study

Effectiveness of endoscopic surgery in the treatment of recurrent nasopharyngeal carcinoma: a prospective,observational, single-arm clinical study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900026341
Enrollment
Unknown
Registered
2019-09-30
Start date
2020-06-01
Completion date
Unknown
Last updated
2020-05-25

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

Conditions

Nasopharyngeal carcinoma

Interventions

Sponsors

Eye, Ear, Nose, and Throat Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Pathological evidence of recurrent or residual nasopharyngeal carcinoma; 2. Aged >=18 years; 3. Without metastasis; 4. Surgical resection benefit the patient; 5. Regional lesion can be treated by topical treatments; 6. ECOG 0 or 1; 7. Surgical resectable; 8. Acceptable organ function; 9. Acceptable contraceptive approach.

Exclusion criteria

Exclusion criteria: 1. Refuse to sign inform consent; 2. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients; 3. Distant metastasis or radiation encephalopathy or leptomeningeal disease (LMD); 4. Have uncontrolled inter-current illnesses which in the opinion of the investigator will interfere with the ability to undergo therapy including chemotherapy; 5. Have a history of a different malignancy, unless the disease has not progressed for >= 2 years. 6. Female patients who are at pregnancy or lactation; 7. Have any co-existing condition that would preclude full compliance with the study; 8. Any contradiction to surgery.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
local recurrence free survival(LRFS);progression free survival(PFS);quality of life;progression free survival(PFS);

Countries

China

Contacts

Public ContactHongmeng Yu

Eye, Ear, Nose, and Throat Hospital, Fudan University

hongmengyush@yahoo.com.cn+86 021-64377134

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026