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Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC) (TPF for NPC)

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:  Not yet recruiting
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00817583
First received: January 5, 2009
Last updated: January 26, 2009
Last verified: January 2009
  Purpose

The primary objective of this study is to determine the response rate, tolerance and overall survival in patients with stage III, IVa, IVb NPC treated with neoadjuvant chemotherapy (TPF regimen) 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,IVa, IVb NPC treated with this regimen.

The third objective of this study is to evaluate who may benifit from this treatment regimen.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phse II Study of Induction Chemotherapy With TPF Regimen Followed by Concurrent Chemoradiotherapy for Locally Advanced 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: 100
Study Start Date: January 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
All patients will receive docetaxel 75 mg/m2 on day 1; cisplatin 75 mg/m2 on day 1; and a continuous intravenous fluorouracil infusion at 500 mg/m2/d on days 1 through 5. Cycles are repeated every 21 days for a total of two cycles. Patients then will receive definitive radiotherapy with 3D-CRT or IMRT, and cisplatin (40mg/m2) weekly during external radiotherapy.The radiation dose is 66-76Gy to the GTV, 60Gy to CTV1, and 54Gy to CTV2.
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

Radiation: 3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)

Detailed Description:
Concurrent chemoradiation is the standard treatment for locally advanced NPC. The survival benefit gained from adding induction chemotherapy to concurrent chemoradiation has not been defined yet. In the present clinical study, we hope to assess the tolerance and survival benefits of induction chemotherapy followed by concurrent chemoradiation in patients with stage III, IVa and IVb NPC.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • -Histopathologically proved WHO type II and type III carcinoma of the nasopharynx.
  • Stage Ⅲ, IVa and IVb 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.
  • the primary tumor or involved lymph node must be more than 2CM in diameter.
  • 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: NCT00817583

Locations
China, Shanghai
Department of Radiation Oncology, Cancer Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: XiaoShen WANG, M.D. Department of Radiation Oncology, Cancer Hospital, Fudan University
Study Chair: ChaoSu HU, M.D. Department of Radiation Oncology, Cancer Hospital, Fudan University
Principal Investigator: ChunYing Shen, M.D. Department of Radiation Oncology, Cancer Hospital, Fudan University
Principal Investigator: HongMei Ying, M.D. Department of Radiation Oncology, Cancer Hospital, Fudan University
  More Information

Responsible Party: cancer hospital, Fudan University
ClinicalTrials.gov Identifier: NCT00817583     History of Changes
Other Study ID Numbers: NPC20081  NPC20081-1 
Study First Received: January 5, 2009
Last Updated: January 26, 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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016