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

NCT00887315 | Terminated Phase 2 Results DMC

• 1 other identifier: 16574B
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 1-Year Overall Survival

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

  Baseline to death from any cause, 1 year

Secondary Outcomes (1)

• Overall PFS and CT Rate

  >90 days

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Chemotherapy only

Drug: Docetaxel and cisplatin

2

ACTIVE COMPARATOR

Chemotherapy and hypofractionated image guided radiotherapy

Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy

Interventions

Docetaxel and cisplatin DRUG

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

Group 1

Docetaxel and cisplatin Plus Hypofractionated Radiotherapy RADIATION

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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 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.
• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Funding was withdrawn before conclusions were reached so the study was terminated and no data was collected and analyzed.

Results Point of Contact

• Title: Dr. Sang Mee Lee
• Organization: Department of Health Studies, University of Chicago

slee@health.bsd.uchicago.edu

773-834-6765

Study Officials

• Everett E Vokes, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2009
• First Posted: April 23, 2009
• Study Start: April 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 6, 2013
• Results First Posted: December 6, 2013

Record last verified: 2013-11

Locations

US (1)