Concurent Chemoradiotherapy in Head and Neck Cancers

NCT ID: NCT04780750

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-09-01

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.

Conditions

Squamous Cell Carcinoma of Head and Neck

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Arm 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

Arm B (standard regimen):concurrent chemoradiotherapy with cisplatin (100mg\\m2 every 3 weeks)

Group Type: ACTIVE_COMPARATOR

Docetaxel

Intervention Type: DRUG

Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\\m2) and cisplatin (80mg\\m2 every 3 weeks)

Interventions

Docetaxel

Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\\m2) and cisplatin (80mg\\m2 every 3 weeks)

Intervention Type: DRUG

Other Intervention Names

taxoter

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

doaa abd elaleem alsayed mohamed

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

doAA ABDELALEEM, Master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

doaa abdelaleem alsayed, MASTER

Role: CONTACT

dodoalemo@yahoo.com

01142753583

amal rayan ibrahim, Master

Role: CONTACT

01022454482

Related Links

https://www.ncbi.nlm.nih.gov/pmc/articles/pmc3577950/

Concurrent chemotherapy and radiotherapy for organ preservation in advanced larynx cancer. N Engl J Med. 2003; 349:2091-2098.

Other Identifiers

head and neck cancers

Identifier Type: -

Identifier Source: org_study_id