Concurent Chemoradiotherapy in Head and Neck Cancers
Primary Purpose
Squamous Cell Carcinoma of Head and Neck
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Squamous Cell Carcinoma of Head and Neck
Eligibility Criteria
Inclusion Criteria:
- pathologically confirmed squmous cell carcinoma performance status 0-1 adequte renal and hepatic function
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Arm A concurrent chemoradiotherapy with weekly docitaxel and cisplatin every 3 weeks
Arm B :concurrent chemoradiotherapy with cisplatin every 3 weeks
Arm Description
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
Arm B (standard regimen):concurrent chemoradiotherapy with cisplatin (100mg\m2 every 3 weeks)
Outcomes
Primary Outcome Measures
locoregional recurrence free survival in months
comparison of the locoregional recurence free survival in both arms
Secondary Outcome Measures
overall survival
overall survival in months in both arms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04780750
Brief Title
Concurent Chemoradiotherapy in Head and Neck Cancers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
Head and neck cancer is the eighth most common cancer in the United States . For locally advanced HNSCC, concurrent chemoradiotherapy (chemo-RT) is the standard treatment established with multiple randomized trials . The survival benefit of chemo-RT in locally advanced HNSCC has been confirmed by meta-analyses, which revealed a 19% reduction in mortality and an absolute survival benefit of 8% at 5years when chemotherapy was administered concurrently with radiation Despite incremental improvements in local regional control and survival in HNSCC patients treated with chemo-RT, a substantial fraction of patients suffer persistent or recurrent diseases. Combining novel agents with radiation therapy therefore remains of great interest to further improving the treatment outcomes of HNSCC .
Cisplatin is the most commonly used chemotherapeutic agent given concurrently with radiation. However, introduction of additional effective radiosensitizing agents is urgently needed. A significant percentage of patients appropriate for definitive concurrent chemo-RT are not candidates for cisplatin based treatment.
Furthermore, recent data have emerged that cisplatin might not be the most optimal cytotoxic radiosensitizing agent when addition of novel targeted agents to concurrent chemo-RT is evaluated.
Radiation Therapy Oncology Group (RTOG) 0234 is a phase II randomized clinical trial evaluating postoperative radiation plus concurrent docetaxel and cetuximab versus postoperative radiation plus cisplatin and cetuximab for high-risk HNSCC after surgery. The results showed an impressive improvement in overall survival and disease-free survival of the docetaxel arm compared to the cisplatin arm (79% versus 69% and 66% versus 57% respectively . These results are pointing to the possibility that a non-cisplatin based regimen chemo-RT should be explored for further development of novel targeted agents and led to a recently opened phase III randomized RTOG trial, RTOG 1216, which compares postoperative radiation with concurrent cisplatin versus docetaxel versus docetaxel and cetuximab for high-risk HNSCC patients . docetaxel appears to have active antitumor activity in advanced SCCHN . In preclinical studies, docetaxel leads to tumor cell reoxygenation and mitotic arrest with potent radiosensitization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Carcinoma of Head and Neck
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A concurrent chemoradiotherapy with weekly docitaxel and cisplatin every 3 weeks
Arm Type
Active Comparator
Arm Description
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
Arm Title
Arm B :concurrent chemoradiotherapy with cisplatin every 3 weeks
Arm Type
Active Comparator
Arm Description
Arm B (standard regimen):concurrent chemoradiotherapy with cisplatin (100mg\m2 every 3 weeks)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
taxoter
Intervention Description
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
Primary Outcome Measure Information:
Title
locoregional recurrence free survival in months
Description
comparison of the locoregional recurence free survival in both arms
Time Frame
1 years
Secondary Outcome Measure Information:
Title
overall survival
Description
overall survival in months in both arms
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
pathologically confirmed squmous cell carcinoma performance status 0-1 adequte renal and hepatic function
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
doaa abdelaleem alsayed, MASTER
Phone
01142753583
Email
dodoalemo@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
amal rayan ibrahim, Master
Phone
01022454482
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
doAA ABDELALEEM, Master
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3577950/
Description
Concurrent chemotherapy and radiotherapy for organ preservation in advanced larynx cancer. N Engl J Med. 2003; 349:2091-2098.
Learn more about this trial
Concurent Chemoradiotherapy in Head and Neck Cancers
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