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

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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Docetaxel and cisplatin; Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; Chemotherapy only	Drug: Docetaxel 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
Active Comparator: 2; Chemotherapy and hypofractionated image guided radiotherapy	Radiation: Docetaxel 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	>90 days

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Everett E Vokes, MD, University Of Chicago

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 22, 2009
• First Submitted That Met QC Criteria: April 22, 2009
• First Posted (Estimate): April 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: NSCLC; Metastatic Stage IV NSCLC; Limited Volume Stage IV Non-small Cell Lung Cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: 16574B