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NCT Number: NCT07361133

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

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.

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Key information

Conditions

Squamous Cell Carcinoma Advanced Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Disease Attributes Head and Neck Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclophosphamide and Etoposide in combination

Drug

Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.

methotrexate

Drug

50 mg weekly for 6 months

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Overall survival

    Time frame: From the first day of study till the end of study at 8 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mahitab Gamal

CONTACT

[email protected]

00201119668735

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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