Lung CancerPhase 3NCT01947062
Metronomic Cyclophosphamide in Combination With Standard Chemotherapy for Squamous Cell Lung Carcinoma
A Phase 3 study testing Intravenous Cisplatin & etoposide and Intravenous Cisplatin & etoposide along with oral cyclophosphamide in people with Lung Cancer and Squamous Cell Carcinoma of the Lung, run by Swami Rama Cancer Hospital and Research Institute at 1 site in India.
Trial summary
Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer, Squamous Cell Carcinoma of the Lung, Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung
- What is being tested?
- Intravenous Cisplatin & etoposide and Intravenous Cisplatin & etoposide along with oral cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2013to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically proven squamous cell carcinoma of the lung
- Surgically unresectable or metastatic disease
Who cannot join
- Severe life limiting diabetes, hypertension or cardiac co-morbidities
- Co-existing tuberculosis
- Brain metastases at presentation
- Non-consenting patients
- Previously treated with any regimen of chemotherapy for existing or previous malignancy
Trial locations and contacts
1 site in 1 country.
India1 site
Swami Rama Cancer Hospital & Research Institute
Haldwani, Nainital, Uttarakhand, 263139
Swaroop Revannasiddaiah, MD, 91 ext. 8971862565, swarooptheone@gmail.com
Swaroop Revannasiddaiah, MD
About this study
Official title: Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma
Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals.
Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies.
This study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.
Read the detailed description
Adenocarinoma and squamous cell carinoma are the two major types of non-small cell lung carcinoma. While patients with adenocarcinoma of the lung have the feasibility of treatment with tyrosine kinase inhibitors, the patients with squamous cell carcinoma can only be treated with standard chemotherapy due to the ineffectiveness of tyrosine kinase inhibitors. Thus, the current standard is to treat patients of squamous cell lung cancers with standard intravenous chemotherapy, which is mostly delivered once in three weeks.
Metronomic chemotherapy, meaning the delivery of low doses of chemotherapy, often by an oral approach, on a daily basis so as to maintain a low but definite level of the chemotherapy has received great interest in recent times due to its beneficial effects in terms of extending progression free survival among patients of various malignancies, even after failure with previous conventional therapies. Metronomic chemotherapy is proposed to be active by alternate mechanisms, such as the predominant anti-angiogenic effect, in contrast to the cytotoxic and genotoxic effects of standard chemotherapy.
Metronomic chemotherapy with oral cyclophosphamide has been shown to extend progression free survival when used as a single agent in various malignancies. Given the fact that progression after varying time spans is a rule (rather than the exception) among patients of squamous cell lung cancer being treated with conventional chemotherapy, we have intended to combine the use of oral metronomic chemotherapy given concurrently with standard intravenous cisplatin-etoposide based chemotherapy. We intend to observe a prolongation of progression free survival.
- Conditions
- Lung Cancer, Squamous Cell Carcinoma of the Lung, Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung
- Being tested
- Intravenous Cisplatin & etoposide, Intravenous Cisplatin & etoposide along with oral cyclophosphamide
- Keywords
- NSCLC, Metronomic chemotherapy, Metronomic cyclophosphamide
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Cisplatin & etoposideDrug
Also called Control arm, Standard intravenous chemotherapy
Patients will receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.
Intravenous Cisplatin & etoposide along with oral cyclophosphamideDrug
Also called Experimental arm, Intravenous with metronomic chemotherapy
Patients will be treated with oral cyclophosphamide at a daily dose of 50mg. Patients will also receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3.
| Study group | Role | What they receive |
|---|---|---|
| Standard intravenous chemotherapy | Active comparator | Patients will receive standard intravenous chemotherapy based on cisplatin and etoposide. Receives: Drug: Intravenous Cisplatin & etoposide |
| Intravenous with metronomic chemotherapy | Experimental | Patients will receive both intravenous (cisplatin and etoposide based) and metronomic chemotherapy (with oral cyclophosphamide). Receives: Drug: Intravenous Cisplatin & etoposide along with oral cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 12 months on average
Secondary outcomes (1)
Response rate
Measured: 12 months on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swami Rama Cancer Hospital and Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Swaroop Revannasiddaiah, Swami Rama Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947062
- Sponsor's protocol ID
- MetroCyclo1
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Benefits of Oral Metronomic Cyclophosphamide in Combination With Standard Cisplatin-etoposide Based Chemotherapy for Squamous Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT01947062
- Acronym / sponsor ID
- MetroCyclo1
- Conditions
- Lung Cancer, Squamous Cell Carcinoma of the Lung, Locally Advanced and Metastatic Squamous Cell Carcinoma of the Lung
- Keywords
- NSCLC, Metronomic chemotherapy, Metronomic cyclophosphamide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Swami Rama Cancer Hospital and Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 20 Sep 2013 (estimated)
- 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.
Treatment of locally advanced and metastatic squamous cell carcinoma of the lung involves the use of chemotherapy as the therapeutic mainstay. Platinum-etoposide regimens (such as cisplatin-etoposide) are the most commonly used chemotherapeutic regimen, which is delivered intravenously in the standard three-weekly intervals.
Recent interest in oral metronomic chemotherapy has arisen, especially due to its beneficial effects in delaying disease progression among heavily pre-treated patients with various malignancies.
This study attempts to combine the use of metronomic chemotherapy concurrently during standard intravenous chemotherapy.
Detailed description
Adenocarinoma and squamous cell carinoma are the two major types of non-small cell lung carcinoma. While patients with adenocarcinoma of the lung have the feasibility of treatment with tyrosine kinase inhibitors, the patients with squamous cell carcinoma can only be treated with standard chemotherapy due to the ineffectiveness of tyrosine kinase inhibitors. Thus, the current standard is to treat patients of squamous cell lung cancers with standard intravenous chemotherapy, which is mostly delivered once in three weeks.
Metronomic chemotherapy, meaning the delivery of low doses of chemotherapy, often by an oral approach, on a daily basis so as to maintain a low but definite level of the chemotherapy has received great interest in recent times due to its beneficial effects in terms of extending progression free survival among patients of various malignancies, even after failure with previous conventional therapies. Metronomic chemotherapy is proposed to be active by alternate mechanisms, such as the predominant anti-angiogenic effect, in contrast to the cytotoxic and genotoxic effects of standard chemotherapy.
Metronomic chemotherapy with oral cyclophosphamide has been shown to extend progression free survival when used as a single agent in various malignancies. Given the fact that progression after varying time spans is a rule (rather than the exception) among patients of squamous cell lung cancer being treated with conventional chemotherapy, we have intended to combine the use of oral metronomic chemotherapy given concurrently with standard intravenous cisplatin-etoposide based chemotherapy. We intend to observe a prolongation of progression free survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard intravenous chemotherapy | Active comparator | Drug: Intravenous Cisplatin & etoposidePatients will receive standard intravenous chemotherapy based on cisplatin and etoposide. |
| Intravenous with metronomic chemotherapy | Experimental | Drug: Intravenous Cisplatin & etoposide along with oral cyclophosphamidePatients will receive both intravenous (cisplatin and etoposide based) and metronomic chemotherapy (with oral cyclophosphamide). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histopathologically proven squamous cell carcinoma of the lung
- Surgically unresectable or metastatic disease
Key exclusion criteria (5 listed)
- Severe life limiting diabetes, hypertension or cardiac co-morbidities
- Co-existing tuberculosis
- Brain metastases at presentation
- Non-consenting patients
- Previously treated with any regimen of chemotherapy for existing or previous malignancy
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 |
|---|---|---|
| Intravenous Cisplatin & etoposideAlso: Control arm, Standard intravenous chemotherapyPatients will receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3. | Drug | Standard intravenous chemotherapy |
| Intravenous Cisplatin & etoposide along with oral cyclophosphamideAlso: Experimental arm, Intravenous with metronomic chemotherapyPatients will be treated with oral cyclophosphamide at a daily dose of 50mg. Patients will also receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 \& 2. The dose of etoposide will be 100mg/m2 on days 1, 2 \& 3. | Drug | Intravenous with metronomic chemotherapy |
Primary outcome
Progression free survival
Time frame: 12 months on average
1 secondary outcome
Response rate
Time frame: 12 months on average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intravenous Cisplatin & etoposide and Intravenous Cisplatin & etoposide along with oral cyclophosphamide in people with Lung Cancer and Squamous Cell Carcinoma of the Lung, run by Swami Rama Cancer Hospital and Research Institute at 1 site in India.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Swaroop Revannasiddaiah, MD (+91 ext. 8971862565, swarooptheone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 12 months on average). 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 20 Sep 2013.