Back to resultsPaclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
Primary Purpose
Squamous Cell Carcinoma Of The Head And Neck
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma Of The Head And Neck
Eligibility Criteria
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
Sites / Locations
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or
Arm Description
Outcomes
Primary Outcome Measures
overall survival
overall survival
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03830385
Brief Title
Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2019 (Actual)
Primary Completion Date
February 15, 2021 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma Of The Head And Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin
Intervention Description
All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy
Primary Outcome Measure Information:
Title
overall survival
Description
overall survival
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Cai, PhD
Phone
0086-20-87342823
Email
caiqq@sysucc.org.cn
Facility Information:
Facility Name
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihua Li, PhD
12. IPD Sharing Statement
Learn more about this trial
Paclitaxel (Albumin Bound),Bleomycin And Cisplatin Or Carboplatin for Recurrent Or Metastatic Squamous Cell Carcinoma Of The Head And Neck
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