NCT03020329

Induction Chemotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Phase II Study of TPF Induction Chemotherapy Followed by Concurrent Chemoradiotherapy in Young Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

1\. To see the effect if a combination of induction chemotherapy followed by chemoradiotherapy works in treating children with advanced nasopharyngeal carcinoma(NPC).

Detailed description

This phase II trial is studying how well radiation therapy and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Conditions

• Nasopharyngeal Carcinoma
• Children

Interventions

Type	Name	Description
DRUG	Paclitaxel liposome	Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy. Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy. Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily.
DRUG	Cisplatin	Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.
DRUG	5-fu	Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.
RADIATION	Radical radiotherapy	Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.

Timeline

• Start date: 2016-11-14
• Primary completion: 2020-12-30
• Completion: 2022-12-30
• First posted: 2017-01-13
• Last updated: 2019-08-07

Locations

1 site across 1 country: China