Squamous Cell CarcinomaPhase 2NCT07361133
Cyclophosphamide and Etoposide as a Metronomic Therapy in Advanced Head and Neck Squamous Cell Cancer
A Phase 2 study testing Cyclophosphamide and Etoposide in combination and Methotrexate in people with Squamous Cell Carcinoma and Advanced Head and Neck Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Advanced Head and Neck Cancer
- What is being tested?
- Cyclophosphamide and Etoposide in combination and Methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2026to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
National Cancer Institute
Cairo, Cairo Governorate, 11796
Zeinab Hassan, 00201021419716, zeinab.hassan@nci.cu.edu.eg
About this study
Official title: Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma
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.
Read more
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.
Read the 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.
- Being tested
- Cyclophosphamide and Etoposide in combination, Methotrexate
- Keywords
- Cyclophosphamide, Etoposide, Head and neck squamous cell carcinoma, Metastatic, Advanced, Recurrent
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasm Metastasis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide and Etoposide in combinationDrug
Cyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months.
MethotrexateDrug
50 mg weekly for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cyclophosphamide and Etoposide in combination |
| Methotrexate | Active comparator | Participants in control arm will receive weekly Methotrexate 50 mg for total 6 months. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first day of the study to the end of treatment at 6 months.
Secondary outcomes (3)
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.
Measured: From the first day of the study till the end of treatment at 6 months
Progression free survival
Evaluation of the progression free survival at the end of study
Measured: From first day of the study till the end of study at 6 months
Overall survival
Measured: From the first day of study till the end of study at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361133
- Sponsor's protocol ID
- MO 2504-505-120-198
- Status last verified
- Jan 2026
- First submitted
- 4 Dec 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participants data can not be shared for patient confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyclophosphamide and Etoposide as a Promising Metronomic Therapy in Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07361133
- Acronym / sponsor ID
- MO 2504-505-120-198
- Keywords
- Cyclophosphamide, Etoposide, Head and neck squamous cell carcinoma, Metastatic, Advanced, Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide and Etoposide in combination | Experimental | Drug: Cyclophosphamide and Etoposide in combinationParticipants 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 | Drug: MethotrexateParticipants in control arm will receive weekly Methotrexate 50 mg for total 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Adjuvant and Neoadjuvant head and neck squamous cell carcinoma patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide and Etoposide in combinationCyclophosphamide IV 400 mg/m2 every 3 weeks and etoposide 100 mg/m2 daily for 3 days every 4 weeks for 6 months. | Drug | Cyclophosphamide and Etoposide in combination |
| Methotrexate50 mg weekly for 6 months | Drug | Methotrexate |
Primary outcome
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participants data can not be shared for patient confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide and Etoposide in combination and Methotrexate in people with Squamous Cell Carcinoma and Advanced Head and Neck Cancer, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahitab Gamal (00201119668735, mahitab2526@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.