Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Egypt
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.
Trial design
Design model
Parallel
Treatments tested in this trial
Cyclophosphamide and Etoposide in combination
DrugCyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.
Methotrexate
Drug50 mg weekly for 6 months
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Cyclophosphamide and Etoposide in combinationExperimental treatment 1 intervention
Group B: MethotrexateActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The efficacy of Cyclophosphamide and Etoposide as metronomic therapy
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.
Time frame
From first day of the study to the end of treatment at 6 months.Secondary outcomes
1
Assessment of clinical symptoms
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.
Time frame
From the first day of the study till the end of treatment at 6 months2
Progression free survival
Evaluation of the progression free survival at the end of study
Time frame
From first day of the study till the end of study at 6 months3
Overall survival
Time frame
From the first day of study till the end of study at 8 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: