Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

NCT ID: NCT00817258

Last Updated: 2009-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-12-31

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.

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 radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.

Group Type: OTHER

cisplatin

Intervention Type: DRUG

Cisplatin 40mg/m2,weekly

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

Intervention Type: RADIATION

3D-CRT or IMRT

Interventions

cisplatin

Cisplatin 40mg/m2,weekly

Intervention Type: DRUG

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

3D-CRT or IMRT

Intervention Type: RADIATION

Eligibility Criteria

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.

• 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-0701

Identifier Type: -

Identifier Source: org_study_id