Phase Ⅱ Study of Neoadjuvant Chemotherapy Followed by Concurrent Chemoradiation for Stage Ⅲ Nasopharyngeal Carcinoma

January 2, 2009 updated by: Fudan University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Department of Radiation Oncology, Cancer Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 3 and 5 years
3 and 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
distant metastases free survival , and disease-free survival
Time Frame: 3 and 5 years
3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (Estimate)

January 5, 2009

Study Record Updates

Last Update Posted (Estimate)

January 5, 2009

Last Update Submitted That Met QC Criteria

January 2, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NPC-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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