Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Phase 2

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

• Registration Number: NCT00817258
• Lead Sponsor: Fudan University

Brief Summary

The primary objective of this study is to determine the overall survival in patients with stage II (T1-2N1M0) NPC treated with concurrent chemotherapy and radiotherapy.

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

Detailed Description

Radiotherapy alone is the standard treatment for early stage NPC. In retrospective study of early stage NPC patients treated with radiotherapy alone. Patients who had Stage II disease had a worse outcome compared with patients with stage I disease. Chemotherapy, delivered concurrently with radiation therapy, has been adopted as standard treatment for locally advanced NPC. However, concurrent chemoradiation for stage II NPC patients has never been prospectively studied. In the present trial, we hope to assess the value of concurrent chemotherapy and radiotherapy in patients with stage II (T1-2N1) NPC.

Study Timeline

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

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
• Stage II disease (T1-2; N1; M0)
• 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	3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)	All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
1	cisplatin	All patients will receive radical 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
disease-free survival, and distant metastases free survival	3 and 5 years

Trial Locations

Locations (1)

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