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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclophosphamide and Etoposide in combination | Experimental | 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. |
|
| Methotrexate | Active Comparator | Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From first day of the study to the end of treatment at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first day of the study till the end of treatment at 6 months |
| Progression free survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahitab Gamal | Contact | 00201119668735 | mahitab2526@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | Cairo Governorate | 11796 | Egypt |
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| Label | URL |
|---|---|
| Related Info | View source |
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Individual participants data can not be shared for patient confidentiality.
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| Methotrexate | Drug | 50 mg weekly for 6 months |
|
Evaluation of the progression free survival at the end of study |
| From first day of the study till the end of study at 6 months |
| Overall survival | From the first day of study till the end of study at 8 months |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D009371 | Neoplasms by Site |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D005047 | Etoposide |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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