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

NCT ID: NCT00816816

Last Updated: 2009-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2010-06-30

Brief Summary

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

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 ⅣAB NPC.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

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.

Group Type: OTHER

docetaxel, cisplatin, fluorouracil

Intervention Type: DRUG

neoadjuvant chemotherapy: 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.

concurrent chemotherapy:cisplatin 40 mg/m2 weekly.

Interventions

docetaxel, cisplatin, fluorouracil

neoadjuvant chemotherapy: 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.

concurrent chemotherapy:cisplatin 40 mg/m2 weekly.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Cancer Hospital, Fudan University, Shanghai, China

Principal Investigators

Lin Kong, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Cancer Hospital, Fudan University

Chaosu Hu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiation Oncology, Cancer Hospital, Fudan University

Locations

Department of Radiation Oncology, Cancer Hospital, Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Lin Kong, MD

Role: CONTACT

konglinj@gmail.com

8621-64175590 ext. 3900

Facility Contacts

Jing Yuan

Role: primary

skelly_sh@hotmail.com

8621-64175590 ext. 6511

Other Identifiers

NPC-0703

Identifier Type: -

Identifier Source: org_study_id