Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: docetaxel, cisplatin, fluorouracil

• Registration Number: NCT00816855
• Lead Sponsor: Fudan University

Brief Summary

The primary objective of this study is to determine the tolerance and overall survival in patients with stage Ⅲ NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage Ⅲ treated with this regimen.

Detailed Description

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. In the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage Ⅲ NPC.

Study Timeline

• Study Start: 2007-02
• Status Verified: 2009-01
• Study First Submitted: 2009-01-02
• Study First Submitted QC: 2009-01-02
• Last Update Submitted: 2009-01-02
• Study First Posted: 2009-01-05
• Last Update Posted: 2009-01-05
• Primary Completion: 2009-12
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
• Stage Ⅲ disease
• KPS >70
• Age between 18-70
• Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (AGC) of > 2000 cells/mm3, platelet count of > 100,000 cells/mm3 (pre treatment without intervention). Bilirubin < 1.5 mg/dl, AST or ALT<2 x upper normal, serum creatinine<1.5mg/dl, creatinine clearance >50ml/min.
• No prior radiation treatment to the head and neck or any prior chemotherapy
• Patients with no prior malignancy (not include basal cell carcinoma of skin)

Exclusion Criteria

• Evidence of metastases (below the clavicle or distant) by clinical or radiographic examinations.
• Prior radiotherapy to the head and neck region for any reason.
• Initial surgical treatment excluding diagnostic biopsy of the primary site or neck disease.
• Patients with previous or simultaneous primaries, excluding basal cell carcinoma or squamous cell carcinoma of skin.
• Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	docetaxel, cisplatin, fluorouracil	All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of three cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.

Primary Outcome Measures

Name	Time	Method
overall survival	3 and 5 years

Secondary Outcome Measures

Name	Time	Method
distant metastases free survival , and disease-free survival	3 and 5 years

Trial Locations

Locations (1)

Department of Radiation Oncology, Cancer Hospital, Fudan University; 🇨🇳 Shanghai, China