Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer

April 13, 2026 updated by: National Cancer Institute, Egypt

Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma

The goal of this clinical trial is to learn if drugs as cyclophosphamide (C) and etoposide (E) work to treat advanced head and neck cancer in adults. It will also learn about the safety of both drugs. The main questions it aims to answer are:

Do drugs C and E work to treat advanced head and neck cancer, after failure on first line chemotherapy? What medical problems do participants have when taking drugs C and E? Researchers will compare drugs C and E in combination to a placebo (a look-alike substance that contains no drug) to see if these 2 drugs works to treat advanced head and neck cancer.

Participants will:

Take drug C every 3 weeks and drug E every 4 weeks or a placebo every week for 6 months.

Visit the clinic once every 3 weeks for checkups and tests. Keep a diary of their symptoms.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This clinical trial aims to evaluate the potential efficacy of cyclophosphamide and etoposide as metronomic therapy in recurrent/resistant and/or metastatic head and neck squamous cell carcinoma adults after failure on first line chemotherapy, or intolerant to further aggressive chemotherapy.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 11796

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult participants, age = or > 18 years
  • Participants with recurrent head and neck squamous cell carcinoma after failure on first line chemotherapy.
  • Participants with advanced progressed, resistant, metastatic head and neck squamous cell carcinoma.

Exclusion Criteria:

  • Adjuvant and Neoadjuvant head and neck squamous cell carcinoma 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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cyclophosphamide and Etoposide in combination
Participants in intervention arm will receive cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks, for total 6 months.
Drug: Cyclophosphamide and Etoposide in combination
Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.
Active Comparator: Methotrexate
Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months.
Drug: Methotrexate
50 mg weekly for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The efficacy of Cyclophosphamide and Etoposide as metronomic therapy
Time Frame: From first day of the study to the end of treatment at 6 months.
The efficacy of Cyclophosphamide and Etoposide as metronomic therapy in improving disease response. Tumor size (tumor dimensions: length, width, height) as measured by Computed Tomography, illustrating whether the disease is progressed, regressed or stationary. In addition to serum LDH level. Both will be assessed every 3 cycles.
From first day of the study to the end of treatment at 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of clinical symptoms
Time Frame: From the first day of the study till the end of treatment at 6 months
Clinical symptoms will be assessed each cycle of treatment through assessment of pain by Numeric Pain Rating Scale, difficulty in swallowing, persistent hoarseness, weight loss.
From the first day of the study till the end of treatment at 6 months
Progression free survival
Time Frame: From first day of the study till the end of study at 6 months
Evaluation of the progression free survival at the end of study
From first day of the study till the end of study at 6 months
Overall survival
Time Frame: From the first day of study till the end of study at 8 months
From the first day of study till the end of study at 8 months

Collaborators and Investigators

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

Sponsor

National Cancer Institute, Egypt

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MO 2504-505-120-198

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participants data can not be shared for patient confidentiality.

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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