Concurent Chemoradiotherapy in Head and Neck Cancers

March 2, 2021 updated by: doaa abd elaleem alsayed mohamed, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm A concurrent chemoradiotherapy with weekly docitaxel and cisplatin every 3 weeks
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
Drug: Docetaxel
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
Other Names:
  • taxoter
ACTIVE_COMPARATOR: Arm B :concurrent chemoradiotherapy with cisplatin every 3 weeks
Arm B (standard regimen):concurrent chemoradiotherapy with cisplatin (100mg\m2 every 3 weeks)
Drug: Docetaxel
Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
Other Names:
  • taxoter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
locoregional recurrence free survival in months
Time Frame: 1 years
comparison of the locoregional recurence free survival in both arms
1 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 5 years
overall survival in months in both arms
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: doAA ABDELALEEM, Master, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

March 2, 2021

First Posted (ACTUAL)

March 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • head and neck cancers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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