NCT00896181

Phase 2 Sequential and Concurrent Chemoradiation for Advanced Nasopharyngeal Carcinoma (NPC)

A Phase 2 Study of Sequential and Concurrent Chemoradiation for Patients With Advanced Nasopharyngeal Carcinoma (NPC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

This phase 2 trial is studying whether giving a combination of docetaxel, cisplatin, and fluorouracil chemotherapy followed by the combination of cisplatin with radiation therapy works in treating patients with advanced nasopharyngeal cancer. Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

Detailed description

PRIMARY OBJECTIVE: • To establish the progression free survival rate at 2 years, using RECIST criteria, to induction treatment with docetaxel, cisplatin, and fluorouracil (TPF) followed by chemoradiotherapy of locoregionally advanced nasopharyngeal carcinoma (NPC) SECONDARY OBJECTIVE: • To evaluate complete response rates, safety and feasibility of TPF followed by chemoradiation in patients with NPC OUTLINE: This is a single site study. INDUCTION THERAPY: Patients receive docetaxel intravenously (IV) over 60 minutes on Day 1; cisplatin IV over 1 to 3 hours (or carboplatin IV over 30 minutes) on Day 1; and fluorouracil IV continuously over 24 hours on Days 1 to 5. Each cycle is 21 days, with treatment consisting of up to 3 cycles in the absence of disease progression or unacceptable toxicity. CONCURRENT CHEMO-RADIOTHERAPY: Beginning within 3 to 6 weeks after initiating the last course of induction chemotherapy, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily for 6.5 to 7 weeks. Patients also receive cisplatin IV over 1 hour (or carboplatin IV over 30 minutes) once weekly in weeks 1 to 6 in the absence of disease progression or unacceptable toxicity. All study treatment is admininstered over the course of 21 weeks. After completion of study treatment, patients are followed periodically for 24 months.

Conditions

• Stage II Lymphoepithelioma of the Nasopharynx
• Stage II Squamous Cell Carcinoma of the Nasopharynx
• Stage III Lymphoepithelioma of the Nasopharynx
• Stage III Squamous Cell Carcinoma of the Nasopharynx
• Stage IV Lymphoepithelioma of the Nasopharynx
• Stage IV Squamous Cell Carcinoma of the Nasopharynx

Interventions

Type	Name	Description
DRUG	docetaxel	Given IV
DRUG	cisplatin	Given IV
DRUG	carboplatin	Given IV
DRUG	fluorouracil	Given IV
RADIATION	3-dimensional conformal radiation therapy	Undergo 3-dimensional conformal or intensity-modulated radiotherapy
RADIATION	intensity-modulated radiation therapy	Undergo 3-dimensional conformal or intensity-modulated radiotherapy

Timeline

• Start date: 2008-12-10
• Primary completion: 2020-01-03
• Completion: 2020-12-01
• First posted: 2009-05-11
• Last updated: 2021-04-06
• Results posted: 2021-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study