Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclophosphamide and Etoposide in combination, Methotrexate.
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma, Advanced Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma
Overview
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.
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.
Interventions
- 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. - Drug Methotrexate
50 mg weekly for 6 months
Primary outcome measures
- 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.]
Secondary outcome measures (3)
- Assessment of clinical symptoms [Time frame: 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]
- Overall survival [Time frame: From the first day of study till the end of study at 8 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National Cancer Institute — Cairo
Identifiers
NCT: NCT07361133 · MO 2504-505-120-198