Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma
NCT ID: NCT03015727
Last Updated: 2017-01-10
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
PHASE3
440 participants
INTERVENTIONAL
2016-12-31
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IC+RT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2. And then radiation using IMRT/TOMO without concurrent chemotherapy.
Docetaxel
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
Cisplatin
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
IMRT/TOMO
intensity modulated radiation therapy or tomotherapy
IC+CCRT group
3 cycles of TP neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2 and cisplatin 75mg/m2.And then chemoradiation using IMRT/TOMO with 2 cycles of cisplatin concurrent chemotherapy at 100mg/m2.
Docetaxel
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
Cisplatin
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
IMRT/TOMO
intensity modulated radiation therapy or tomotherapy
Chemotherapy
2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
Interventions
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Docetaxel
3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
Cisplatin
3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
IMRT/TOMO
intensity modulated radiation therapy or tomotherapy
Chemotherapy
2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Tumor staged as N2-3 or T3-4 (according to the 7th AJCC staging system)
3. No evidence of distant metastasis (M0)
4. Performance status: KPS\>70
5. With normal liver function test (ALT, AST \<1.5ULN)
6. Renal: creatinine clearance \>60ml/min
7. Without hematopathy,marrow: WBC \>4\*109/L, HGB\>80G/L, and PLT\>100\*109/L.
8. With controlled blood glucose for diabetes patients
9. Written informed consent
10. satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT)
Exclusion Criteria
2. Age \>65 or \<18
3. With a history of renal disease
4. Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
5. Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
6. Patient is pregnant or lactating
7. Peripheral neuropathy
8. Emotional disturbance
18 Years
65 Years
ALL
No
Sponsors
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Zhejiang Provincial People's Hospital
OTHER
The Central Hospital of Lishui City
OTHER
Jinhua Central Hospital
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Ningbo Medical Center Lihuili Eastern Hospital
UNKNOWN
People's Hospital of Quzhou
OTHER
Zhejiang Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiaozhong Chen
Role: STUDY_CHAIR
Zhejiang Cancer Hospital
Locations
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Xiaozhong Chen
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZhejiangCH 01536224
Identifier Type: -
Identifier Source: org_study_id
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