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

NCT ID: NCT00887315

Last Updated: 2013-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Chemotherapy only

Group Type: ACTIVE_COMPARATOR

Docetaxel and cisplatin

Intervention Type: 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

2

Chemotherapy and hypofractionated image guided radiotherapy

Group Type: ACTIVE_COMPARATOR

Docetaxel and cisplatin Plus Hypofractionated Radiotherapy

Intervention Type: RADIATION

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: RADIATION

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Everett E Vokes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

The University of Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

16574B

Identifier Type: -

Identifier Source: org_study_id