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Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB 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:
NCT00816816
First received: January 2, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted

January 2, 2009
January 2, 2009
February 2007
December 2009   (final data collection date for primary outcome measure)
overall survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
distant metastases free survival, and disease-free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma
Phase ⅡStudy of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage ⅣAB Nasopharyngeal Carcinoma

The primary objective of this study is to determine the tolerance and overall survival in patients with stage ⅣAB NPC treated with neoadjuvant chemotherapy and concurrent chemoradiation.

Secondary objectives of the study are to evaluate the distant metastases free survival, and disease-free survival of patients with stage ⅣAB treated with this regimen

Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding neoadjuvant chemotherapy to concurrent chemoradiation has never been defined. In the present trail, we hope to assess the tolerance and survival benefits of neoadjuvant chemotherapy followed by concurrent chemoradiation in patients with stage ⅣAB NPC.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Nasopharyngeal Carcinoma
Drug: docetaxel, cisplatin, fluorouracil

neoadjuvant chemotherapy: docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5.

concurrent chemotherapy:cisplatin 40 mg/m2 weekly.

1
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of three cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.
Intervention: Drug: docetaxel, cisplatin, fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
64
June 2010
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically proven differentiated non-keratinizing carcinoma, and undifferentiated carcinoma of the nasopharynx.
  • Stage ⅣAB disease
  • 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
Both
18 Years to 70 Years
No
Contact: Lin Kong, MD 8621-64175590 ext 3900 konglinj@gmail.com
China
 
NCT00816816
NPC-0703
Yes
Department of Radiation Oncology,Cancer Hospital, Fudan University, Shanghai, China, Cancer Hospital, Fudan University, Shanghai, China
Fudan University
Not Provided
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
Fudan University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP