Advanced Head and Neck Cancer, Squamous Cell Carcinoma
Conditions
Keywords
Cyclophosphamide, Etoposide, Head and neck squamous cell carcinoma, Metastatic, Advanced, Recurrent
Brief summary
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
DRUGCyclophosphamide 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.
DRUGMethotrexate
50 mg weekly for 6 months
Sponsors
National Cancer Institute, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy of Cyclophosphamide and Etoposide as metronomic therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Assessment of clinical symptoms | 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. |
| Progression free survival | 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 |
| Overall survival | From the first day of study till the end of study at 8 months | — |
Countries
Egypt
Contacts
CONTACTMahitab Gamal
Outcome results
None listed