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Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Fudan University.
Recruitment status was:  Recruiting
Information provided by:
Fudan University Identifier:
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009

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

Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: cisplatin
Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

Resource links provided by NLM:

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • overall survival [ Time Frame: 3 and 5 years ]

Secondary Outcome Measures:
  • disease-free survival, and distant metastases free survival [ Time Frame: 3 and 5 years ]

Estimated Enrollment: 37
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
All patients will receive radical radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
Drug: cisplatin
Cisplatin 40mg/m2,weekly
Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00817258

Contact: Lin Kong, MD 8621-64175590 ext 3900

Department of Radiation Oncology, Cancer Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Jing Yuan    8621-64175590 ext 6511   
Sponsors and Collaborators
Fudan University
Principal Investigator: Lin Kong, MD Department of Radiation Oncology, Cancer Hospital, Fudan University
Principal Investigator: Chaosu Hu, MD Department of Radiation Oncology, Cancer Hospital, Fudan University
  More Information

Responsible Party: Department of Radiation Oncology,Cancer Hospital, Fudan University, Shanghai, China, Cancer Hospital, Fudan University, Shanghai, China Identifier: NCT00817258     History of Changes
Other Study ID Numbers: NPC-0701
Study First Received: January 2, 2009
Last Updated: January 5, 2009

Keywords provided by Fudan University:
Phase 2 Clinical Trial
radiation therapy

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Antineoplastic Agents processed this record on April 26, 2017