Non-small Cell Lung CancerPhase 2SMARTNCT00887315
The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC)
A Phase 2 study testing Docetaxel and cisplatin and Docetaxel and cisplatin Plus Hypofractionated Radiotherapy in people with Non-small Cell Lung Cancer, run by University of Chicago at 1 site in United States.
Trial summary
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Docetaxel and cisplatin and Docetaxel and cisplatin Plus Hypofractionated Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 years or older
- Life expectancy > 6 months
- Histologically or cytologically confirmed diagnosis of NSCLC
- Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
- Patients with pleural effusion that is transudative, cytologically negative, and non-bloody are eligible as long as they are stable and do not impair the ability to define tumor volumes.
- If a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible.
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- Primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
- Patients with 1-5 sites of disease and amenable to RT therapy as seen on standard imaging (CT, MRI, bone scan, PET scan)
- Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required.
- Patients with brain metastases are allowed as long as they meet all other inclusion criteria. Brain metastases must be treated with whole brain radiotherapy and stereotactic radiosurgery or surgical resection followed by whole brain radiotherapy.
- ECOG performance status <2
- No prior RT to currently involved tumor sites
- Baseline peripheral neuropathy < grade 1
- Room air saturation (SaO2) > 90%
- Patients must have normal organ and marrow function
- Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.
- Signed Informed consent
- Inclusion of Women and Minorities
- RT: Patient must have a completed treatment plan approved by the protocol review team
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
- Patients with significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine.
- < 1000 cc of tumor free lung.
- Tumor volume and location which requires a lung volume-PTV >40% to receive >20 Gy (V20 <40%).
- Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
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- Pregnancy or breast feeding (Women of child-bearing potential are eligible, but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)
- Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
- Patient may not be receiving any other investigational agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Phase II Trial of Docetaxel, Cisplatin, and Hypofractionated Radiotherapy Versus Docetaxel and Cisplatin for Limited Volume Stage IV Non-small Cell Lung Cancer: The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Docetaxel and cisplatin, Docetaxel and cisplatin Plus Hypofractionated Radiotherapy
- Keywords
- NSCLC, Metastatic Stage IV NSCLC, Limited Volume Stage IV Non-small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Docetaxel and cisplatinDrug
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles
Docetaxel and cisplatin Plus Hypofractionated RadiotherapyRadiation
Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Chemotherapy only Receives: Drug: Docetaxel and cisplatin |
| 2 | Active comparator | Chemotherapy and hypofractionated image guided radiotherapy Receives: Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Overall Survival
Overall survival is assessed at 1 year from the date of study enrollment to date of death.
Measured: Baseline to death from any cause, 1 year
Secondary outcomes (1)
Overall PFS and CT Rate
Overall PFS and CT rate is assessed response with PET and CT. Toxicity of addition of high dose focused RT to systemic therapy.Late (>90 day) radiotherapy toxicity will be assessed with RTOG/EORTC late RT toxicity guidelines
Measured: >90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionJun 2011
Why it stopped: Slow accrual and loss of sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett E Vokes, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887315
- Sponsor's protocol ID
- 16574B
- Acronym
- SMART
- Status last verified
- Nov 2013
- First submitted
- 22 Apr 2009
- Last updated
- 6 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Trial of Docetaxel, Cisplatin, and Hypofractionated Radiotherapy Versus Docetaxel and Cisplatin for Limited Volume Stage IV Non-small Cell Lung Cancer: The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial
- ClinicalTrials.gov ID
- NCT00887315
- Acronym / sponsor ID
- SMART / 16574B
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, Metastatic Stage IV NSCLC, Limited Volume Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual and loss of sponsor
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Posted 6 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary goal of the study is to assess the overall survival of the addition of hypofractionated image guided radiotherapy concurrently with Docetaxel and cisplatin. Survival will be assessed at 1 year from the date of study enrollment to date of death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Docetaxel and cisplatinChemotherapy only |
| 2 | Active comparator | Radiation: Docetaxel and cisplatin Plus Hypofractionated RadiotherapyChemotherapy and hypofractionated image guided radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18 years or older
- Life expectancy > 6 months
- Histologically or cytologically confirmed diagnosis of NSCLC
- Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study
- Primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
Key exclusion criteria (10 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements
- Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary heart disease will be at the discretion of the attending physician.
- Patients with significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine.
- < 1000 cc of tumor free lung.
- Tumor volume and location which requires a lung volume-PTV >40% to receive >20 Gy (V20 <40%).
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 |
|---|---|---|
| Docetaxel and cisplatinDocetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV repeated every 21 days for 2 additional cycles. For patients randomized to group 1, the chemotherapy is identical to that administered for the first 2 cycles | Drug | Group 1 |
| Docetaxel and cisplatin Plus Hypofractionated RadiotherapyDocetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease | Radiation | 2 |
Primary outcome
1-Year Overall Survival
Time frame: Baseline to death from any cause, 1 year
Overall survival is assessed at 1 year from the date of study enrollment to date of death.
1 secondary outcome
Overall PFS and CT Rate
Time frame: >90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Everett E Vokes, MD principal investigator
University of Chicago
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 Docetaxel and cisplatin and Docetaxel and cisplatin Plus Hypofractionated Radiotherapy in people with Non-small Cell Lung Cancer, run by University of Chicago at 1 site in United States.
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 19 inclusion and 10 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: stopped early, as of the sponsor's last update on 6 Dec 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 United States. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Overall Survival (time frame: Baseline to death from any cause, 1 year). 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 6 Dec 2013.