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

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: docetaxel, cisplatin, fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT00816816

NPC-0703

Details and patient eligibility

About

The primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅣAB 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 ⅣAB treated with this regimen

Full 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 ⅣAB NPC.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
• Stage ⅣAB 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

1

Other group

Description:

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.

Treatment:

Drug: docetaxel, cisplatin, fluorouracil