NCT03830385

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

February 15, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

January 31, 2019

Last Update Submit

July 13, 2019

Conditions

Squamous Cell Carcinoma Of The Head And Neck

Outcome Measures

Primary Outcomes (1)

  • overall survival

    overall survival

    5 years

Study Arms (1)

Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or

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

Interventions

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

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

Paclitaxel (Albumin Bound),Bleomycin and Cisplatin or

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • years or older; without other malignancy;
  • proper functioning of the major organs.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

CisplatinCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsHead and Neck NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsCoordination ComplexesOrganic Chemicals

Central Study Contacts

Qingqing Cai, PhD

CONTACT

0086-20-87342823caiqq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 5, 2019

Study Start

February 15, 2019

Primary Completion

February 15, 2021

Study Completion

February 15, 2026

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

CN(1)