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Concurent Chemoradiotherapy in Head and Neck Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04780750
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Information provided by (Responsible Party):
doaa abd elaleem alsayed mohamed, Assiut University

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

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Drug: Docetaxel Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine

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 Name: 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 Name: taxoter

Primary Outcome Measures :
  1. locoregional recurrence free survival in months [ Time Frame: 1 years ]
    comparison of the locoregional recurence free survival in both arms

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    overall survival in months in both arms

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04780750

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Contact: doaa abdelaleem alsayed, MASTER 01142753583
Contact: amal rayan ibrahim, Master 01022454482

Sponsors and Collaborators
Assiut University
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Principal Investigator: doAA ABDELALEEM, Master Assiut University
Additional Information:
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Responsible Party: doaa abd elaleem alsayed mohamed, principle investigator, Assiut University Identifier: NCT04780750    
Other Study ID Numbers: head and neck cancers
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action