Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Nasopharyngeal Carcinoma

NCT ID: NCT03015727

Last Updated: 2017-01-10

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2024-12-31

Brief Summary

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In this study, the investigators aim to compare the progression-free survival (PFS) and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT).

Detailed Description

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In this study, the investigators aim to compare the survival outcomes and side effects of radiotherapy (RT) and concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) patients with a satisfactory tumor response (complete response or partial response) after neoadjuvant chemotherapy (NACT) with Docetaxel and Cisplatin treated using intensity-modulated radiotherapy (IMRT) or tomotherapy (TOMO).

Conditions

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Locally Advanced Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.

Cisplatin

Intervention Type DRUG

3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.

IMRT/TOMO

Intervention Type RADIATION

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.

Group Type ACTIVE_COMPARATOR

Docetaxel

Intervention Type DRUG

3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.

Cisplatin

Intervention Type DRUG

3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.

IMRT/TOMO

Intervention Type RADIATION

intensity modulated radiation therapy or tomotherapy

Chemotherapy

Intervention Type DRUG

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.

Intervention Type DRUG

Cisplatin

3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.

Intervention Type DRUG

IMRT/TOMO

intensity modulated radiation therapy or tomotherapy

Intervention Type RADIATION

Chemotherapy

2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.

Intervention Type DRUG

Other Intervention Names

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DOC DDP concurrent chemotherapy

Eligibility Criteria

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Inclusion Criteria

1. Patients with newly histologically confirmed non-keratinizing carcinoma.
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

1. WHO type I squamous cell carcinoma or adenocarcinoma
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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Jinhua Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Ningbo Medical Center Lihuili Eastern Hospital

UNKNOWN

Sponsor Role collaborator

People's Hospital of Quzhou

OTHER

Sponsor Role collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaozhong Chen

Role: STUDY_CHAIR

Zhejiang Cancer Hospital

Locations

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Xiaozhong Chen

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaozhong Chen

Role: CONTACT

Facility Contacts

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Xiaozhong Chen, MD

Role: primary

+86-571-88128202

Other Identifiers

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ZhejiangCH 01536224

Identifier Type: -

Identifier Source: org_study_id

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