Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma (NPC)
NCT ID: NCT00817583
Last Updated: 2009-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2009-01-31
2011-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Interventions
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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
3D-CRT (three-dimensional conformal radiation therapy) or IMRT (intensity-modulated radiation therapy)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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cancer hospital, Fudan University
Principal Investigators
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XiaoShen WANG, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Cancer Hospital, Fudan University
ChaoSu HU, M.D.
Role: STUDY_CHAIR
Department of Radiation Oncology, Cancer Hospital, Fudan University
ChunYing Shen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Cancer Hospital, Fudan University
HongMei Ying, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Radiation Oncology, Cancer Hospital, Fudan University
Locations
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Department of Radiation Oncology, Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NPC20081
Identifier Type: -
Identifier Source: secondary_id
NPC20081-1
Identifier Type: -
Identifier Source: secondary_id
NPC20081
Identifier Type: -
Identifier Source: org_study_id
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