The role of splitted temporal fascia (muscle) flaps in skull base reconstruction for recurrent nasopharyngeal carcinoma: a prospective, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035840

Enrollment

Unknown

Registered

2020-08-18

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-08-24

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

Conditions

Nasopharyngeal carcinoma

Interventions

splitted temporal fascia (muscle) flaps for skull base reconstruction:splitted temporal fascia (muscle) flaps for skull base reconstruction

full thick temporal fascia (muscle) flaps for skull base reconstruction:full thick temporal fascia (muscle) flaps for skull base reconstruction

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signed inform consent; ECOG score 0 or 1; general health status suitable for skull base surgery,no severe comorbidilties;Aged 18 to 75 years; 2. Previous pathological evidence of NPC,including Nonkeratinizing carcinoma, keratinizing squamous cell carcinoma and basaloid squamous cell carcinoma; Pathological evidence of rNPC locally; Surgical resectable disease; 3. T3 or T4 4. Regional lymph node can be treated by topical treatments. 5. Without metastasis; 6. Applicable for type III or IV endoscopic nasopharyngectomy;applicable for temporal fascia (muscle) flaps translocation. 7. Previous radical radiotherapy once, without IMXT treatment within 6 months; Expected life span >= 6 months; 8. Acceptable organ function.

Exclusion criteria

Exclusion criteria: 1. History of radioactive particle planting or multiple radiotherapy; 2. primary NPC; 3. History of surgery or radiotherapy for recurrent disease; 4. Have uncontrolled intercurrent illnesses which will interfere with the ability to undergo therapy; 5. Have a history of a different malignancy unless the disease was stable for >=2 years; 6. Have any co-existing condition that would preclude full compliance or safety with the study; 7. Female patients who are at pregnancy or lactation; 8. no need for temporal fascia (muscle) flaps translocation.

Design outcomes

Secondary

Measure	Time frame
Overall Survival;local recurrence free survival;progression free survival;distant metastasis free survival;	—

Primary

Measure	Time frame
incidence rate of the following:Dead space formation or Posterior nostril stenosis;Quality of Life;	—

Countries

China

Contacts

Public ContactXicai Sun

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

laryngeal@163.com+86 021-64377134

Outcome results

None listed

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