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

Sponsor
National Cancer Institute, Egypt
Study ID
NCT07361133
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Jan 22, 2026
Start date
Apr 30, 2026
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Methotrexate
    Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months.

Primary Outcome Measure

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. ]

Central Contacts

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