Concurent Chemoradiotherapy in Head and Neck Cancers
Phase III Study Comparing Concurrent Chemoradiotherapy With Weekly Docitaxel Plus Cisplatin Versus the Standard Concurrent Radiotherapy With Cisplatin in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
To compare the efficacy and toxicities of the combination between weekly docitaxel and cisplatin (every3 week) concurrent with radiation versus the standard concurrent chemoradiotherapy with high dose cisplatin (100mg\\m2) for locally advanced HNSCC
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2021
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMarch 3, 2021
February 1, 2021
1 year
February 15, 2021
March 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
locoregional recurrence free survival in months
comparison of the locoregional recurence free survival in both arms
1 years
Secondary Outcomes (1)
overall survival
5 years
Study Arms (2)
Arm A concurrent chemoradiotherapy with weekly docitaxel and cisplatin every 3 weeks
ACTIVE COMPARATORArm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\\m2) and cisplatin (80mg\\m2 every 3 weeks)
Arm B :concurrent chemoradiotherapy with cisplatin every 3 weeks
ACTIVE COMPARATORArm B (standard regimen):concurrent chemoradiotherapy with cisplatin (100mg\\m2 every 3 weeks)
Interventions
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\\m2) and cisplatin (80mg\\m2 every 3 weeks)
Eligibility Criteria
You may qualify if:
- pathologically confirmed squmous cell carcinoma performance status 0-1 adequte renal and hepatic function
You may not qualify if:
- poor performance status
- impaired renal or hepatic function
- =Squamous cell carcinoma of salivary gland,parotid and paranasal carcinomas were --0excluded from the study
- patients with ≥ grade 2 pre-existing peripheral neuropathy, history of allergic reactions to the chemotherapeutic agents, and uncontrolled intercurrent diseases as well as HIV positive patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
doAA ABDELALEEM, Master
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
February 15, 2021
First Posted
March 3, 2021
Study Start
April 1, 2021
Primary Completion
April 1, 2022
Study Completion
September 1, 2022
Last Updated
March 3, 2021
Record last verified: 2021-02