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

NCT ID: NCT03830385

Last Updated: 2019-07-16

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2026-02-15

Brief Summary

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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

Detailed Description

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Conditions

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Squamous Cell Carcinoma Of The Head And Neck

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or

Group Type EXPERIMENTAL

PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Qingqing Cai

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qingqing Cai, PhD

Role: CONTACT

0086-20-87342823

Facility Contacts

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Zhihua Li, PhD

Role: primary

Other Identifiers

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B2018-138

Identifier Type: -

Identifier Source: org_study_id

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