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Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ 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:
NCT00816855
First received: January 2, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

The primary objective of this study is to determine the tolerance and overall survival in patients with stage Ⅲ 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 Ⅲ treated with this regimen.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: docetaxel, cisplatin, fluorouracil
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ 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:
  • distant metastases free survival , and disease-free survival [ Time Frame: 3 and 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 52
Study Start Date: February 2007
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: docetaxel, cisplatin, fluorouracil

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

concurrent chemotherapy:cisplatin 40 mg/m2 weekly


Detailed Description:

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 Ⅲ 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 Ⅲ 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
  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: NCT00816855

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: NCT00816855     History of Changes
Other Study ID Numbers: NPC-0702
Study First Received: January 2, 2009
Last Updated: January 2, 2009
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Phase 2 Clinical Trial
NPC
neoadjuvant chemotherapy
concurrent chemoradiation

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
Docetaxel
Fluorouracil
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014