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Study of Concurrent Chemotherapy and Radiotherapy for Stage II Nasopharyngeal Carcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Fudan University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00817258
First received: January 2, 2009
Last updated: January 5, 2009
Last verified: January 2009
  Purpose

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: Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

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
1
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)
3D-CRT or IMRT

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT00817258

Contacts
Contact: Lin Kong, MD 8621-64175590 ext 3900 konglinj@gmail.com

Locations
China
Department of Radiation Oncology, Cancer Hospital, Fudan University Recruiting
Shanghai, China, 200032
Contact: Jing Yuan    8621-64175590 ext 6511    skelly_sh@hotmail.com   
Sponsors and Collaborators
Fudan University
Investigators
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

No publications provided

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

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

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014