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

Phase 2

Terminated

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Docetaxel and cisplatin; Radiation: Docetaxel and cisplatin Plus Hypofractionated Radiotherapy

• Registration Number: NCT00887315
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-23
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Results First Submitted: 2013-06-24
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-13
• Last Update Submitted: 2013-11-13
• Results First Posted: 2013-12-06
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Docetaxel and cisplatin	Chemotherapy only
2	Docetaxel and cisplatin Plus Hypofractionated Radiotherapy	Chemotherapy and hypofractionated image guided radiotherapy

Primary Outcome Measures

Name	Time	Method
1-Year Overall Survival	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.

Secondary Outcome Measures

Name	Time	Method
Overall PFS and CT Rate	>90 days	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

Trial Locations

Locations (1)

The University of Chicago; 🇺🇸 Chicago, Illinois, United States