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TerminatedNCT00887315SMARTUpdated Dec 6, 2013Results posted

The Synergistic Metastases Annihilation With Radiotherapy and Docetaxel (Taxotere) [SMART] Trial for Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 interventional study of Docetaxel and cisplatin and Docetaxel and cisplatin Plus Hypofractionated Radiotherapy in Non-small Cell Lung Cancer, sponsored by University of Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-06.

Sponsored by University of Chicago · Phase 2, Interventional, and Treatment

Why this study was terminated
Slow accrual and loss of sponsor
Phase
Phase 2
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • NSCLC
  • Metastatic Stage IV NSCLC
  • Limited Volume Stage IV Non-small Cell Lung Cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 11 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  1. Age 18 years or older
  2. Life expectancy > 6 months
  3. Histologically or cytologically confirmed diagnosis of NSCLC
  4. Patients with AJCC stage IV cancer with distant metastases and without malignant pleural or pericardial effusion at diagnosis and before start of study

    1. 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.
    2. If a pleural effusion is too small for diagnostic thoracentesis, the patient will be eligible.
  5. Primary and regional nodal disease that is encompassable in a reasonable radiotherapy portal:
  6. Patients with 1-5 sites of disease and amenable to RT therapy as seen on standard imaging (CT, MRI, bone scan, PET scan)
  7. Unidimensionally measurable disease (based on RECIST) is desirable but not strictly required.
  8. 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.
  9. ECOG performance status \<2
  10. No prior RT to currently involved tumor sites
  11. Baseline peripheral neuropathy \< grade 1
  12. Room air saturation (SaO2) > 90%
  13. Patients must have normal organ and marrow function
  14. 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.
  15. Signed Informed consent
  16. Inclusion of Women and Minorities
  17. RT: Patient must have a completed treatment plan approved by the protocol review team

Exclusion Criteria:

  1. 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
  2. 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.
  3. Patients with significant atelectasis such that CT definition of the gross tumor volume (GTV) is difficult to determine.
  4. \< 1000 cc of tumor free lung.
  5. Tumor volume and location which requires a lung volume-PTV >40% to receive >20 Gy (V20 \<40%).
  6. Patients with exudative, bloody, or cytologically malignant effusions are not eligible.
  7. 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)
  8. Patients must have no uncontrolled active infection other than that not curable without treatment of their cancer.
  9. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  10. Patient may not be receiving any other investigational agents.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    Group 1

    Chemotherapy only

    Drug: Docetaxel and cisplatin

  • Active comparator
    2

    Chemotherapy and hypofractionated image guided radiotherapy

    Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy

Interventions

  • DrugDocetaxel and cisplatin

    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

  • RadiationDocetaxel and cisplatin Plus Hypofractionated Radiotherapy

    Docetaxel 75 mg/m2 and cisplatin 75 mg/m2 IV for 2 cycles along with hypofractionated radiotherapy to all known sites of disease

06

What researchers measure

Primary outcomes

  1. 1-Year Overall Survival

    Overall survival is assessed at 1 year from the date of study enrollment to date of death.

    Time frame: 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

    Time frame: >90 days

07

Results

Posted Dec 6, 2013
Limitations and caveats
Funding was withdrawn before conclusions were reached so the study was terminated and no data was collected and analyzed.

Participant flow

Funding was withdrawn before conclusions were reached so the study was terminated.

Participant flow — Overall Study
MilestoneChemo OnlyChemo and Radiation
Started74
Completed00
Not completed74
Withdrew: Study termination74

Outcome measures

Primary1-Year Overall Survival

Overall survival is assessed at 1 year from the date of study enrollment to date of death.

Time frame:
Baseline to death from any cause, 1 year

No measurements were reported for this outcome.

SecondaryOverall 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

Time frame:
>90 days

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Chemo Only———
Chemo and Radiation———

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Chemo OnlyChemo and RadiationTotal
<=18 years000
Between 18 and 65 years303
>=65 years448
Age Continuous
Age Continuous(years)Chemo OnlyChemo and RadiationTotal
Mean66.4 ± 10.674 ± 3.269.1 ± 9.2
Sex: Female, Male
Sex: Female, Male(Participants)Chemo OnlyChemo and RadiationTotal
Female527
Male224
08

Study locations

1 site
  • The University of Chicago
    Chicago, Illinois 60637, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00887315
Lead sponsor
University of Chicago
Responsible party
Sponsor
First posted
Apr 23, 2009
Start date
Apr 2009
Primary completion
Mar 2011
Completion
Jun 2011
Results posted
Dec 6, 2013
Last update
Dec 6, 2013

Study contacts

Everett E Vokes, MD
principal investigator · University of Chicago

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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