Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)

Phase 2

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: docetaxel, cisplatin, fluorouracil; Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

• Registration Number: NCT00817583
• Lead Sponsor: Fudan University

Brief Summary

The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) 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,IVa, IVb NPC treated with this regimen.

The third objective of this study is to evaluate who may benifit from this treatment regimen.

Detailed Description

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Last Update Submitted: 2009-01-26
• Last Update Posted: 2009-01-27
• Primary Completion: 2010-07
• Study Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
• Stage Ⅲ, IVa and IVb 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.
• the primary tumor or involved lymph node must be more than 2CM in diameter.
• 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 intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
1	3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)	All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.

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, Shanghai, China