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NCT03830385 Clinical Trial

Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

Squamous Cell Carcinoma Of The Head And Neck Clinical Trial

Official title:
Open-Label, Multicenter, Phase Ⅱ Study Of Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin As First-Line Treatment In Patients With Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03830385
Other study ID # B2018-138
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 15, 2019
Est. completion date February 15, 2026

Study information
Verified date July 2019
Source Sun Yat-sen University
Contact Qingqing Cai, PhD
Phone 0086-20-87342823
Email caiqq@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this single arm, phase Ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent Or metastatic squamous cell carcinoma of the head and neck

Recruitment information / eligibility
Status Recruiting
Enrollment 51
Est. completion date February 15, 2026
Est. primary completion date February 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- biopsy proved squamous cell carcinoma of the head and neck;

- stage IVc according to Union for International Cancer Control (UICC) edition VIII, or recurrent disease after chemotherapy and/or radiotherapy;

- 18 years or older; without other malignancy;

- proper functioning of the major organs.

Exclusion Criteria:

- allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ;

- female within gestation period or lactation;

- patients received drug of other clinical trial within 3 months

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy

Locations
Country Name City State
China Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival overall survival 5 years
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