Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00817258
• Other study ID #: NPC-0701
• Status: Recruiting
• Phase: Phase 2
• First received: January 2, 2009
• Last updated: January 5, 2009
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2009
• Source: Fudan University
• Contact: Lin Kong, MD
• Phone: 8621-64175590
• Email: konglinj[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. completion date: December 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• cisplatin
Cisplatin 40mg/m2,weekly

Radiation:
• 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
3D-CRT or IMRT

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		3 and 5 years	Yes
Secondary	disease-free survival, and distant metastases free survival		3 and 5 years	Yes