Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Brief Title

Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Official Title

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

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

overall survival

Secondary Outcome

 disease-free survival, and distant metastases free survival

Condition

Nasopharyngeal Carcinoma

Intervention

cisplatin

Study Arms / Comparison Groups

Description:  All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

January 2007

Completion Date

December 2009

Primary Completion Date

June 2009

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.

Gender

All

Ages

18 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Lin Kong, MD, 8621-64175590, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT00817258

Organization ID

NPC-0701

Study Sponsor

Fudan University

Study Sponsor

Lin Kong, MD, Principal Investigator, Department of Radiation Oncology, Cancer Hospital, Fudan University

Verification Date

January 2009