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Study Summary
No. 2005-0574:.......Lung......Joe Y. Chang......Radiation Oncology
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Study Summary Title
Study Summary
Number:
2005-0574
Study Title:Phase II stereotactic body radiotherapy for stage I (T1-T2, N0, M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent Non-Small Cell Lung Cancer (NSCLC)
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Physician New Patient Referral
Name:Joe Y. ChangPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Radiation OncologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-2300
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:Phase IIReturn
Visit:
Patients will be followed 6 weeks after RT and then every 3 months for two
years. For this protocol purpose, we are going to follow patients for minimal
two years to finish this protocol.
Treatment
Agents:
RadiationHome Care:n/a
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
n/a
Description/
Intervention:
The goal of this clinical research study is to learn if stereotactic body
radiotherapy (SBRT) can help to control NSCLC. The safety of SBRT will also be
studied.
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Study Objectives / Outcomes
To assess therapeutic efficacy and toxicities of stereotactic body radiotherapy (SBRT) for patients with medically inoperable stage I (T1-2, N0,M0), selective stage II (chest wall T3, N0M0) or isolated peripheral lung recurrent non-small cell lung cancer (NSCLC).

Primary goal: Improve 2 years progression free survival at the treated primary tumor site.

Secondary goals:
1. Improve disease free survival, disease specific survival and overall survival at 2 years.
2. Decrease grade 3 and above acute and/or chronic toxicities.
3. Collect blood for future biomarkers study
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Study Status Information
Study Activation / Registration Date:11/21/2005
IRB Review and Approval Date:11/21/2005
Study Type:Phase Ii Or Phase I/Ii
Recruitment Status:Open
Projected Accrual:N/A
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Cohort 1: Histologically or cytologically documented NSCLC.

2) Cohort 1: Inoperable stage IA (T1N0MO), IB (T2N0MO) and selective stage II (T3 due to chest wall involvement, N0M0). Patient refuses surgery is eligible. Secondary lung cancer is eligible if primary cancers have been cured or stable with life expectance longer than 2 years. If primary cancer is lung cancer, patient needs to be lung cancer free for more than 5 year for same histology or more than 2 years for different histology.

3) Cohort 1: Patients with hilar or mediastinal lymph nodes <= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but on-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Patient who received induction chemotherapy or other systemic therapy are eligible.

4) Cohort 1: Performance score KPS 60-100.

5) Cohort 2: Histologically or cytologically documented NSCLC.

6) Cohort 2: Inoperable isolated lung parenchyma recurrent NSCLC without evidence of lymph node or mediastinal involvement (clinical stage T1-2, chest wall involvement T3, N0M0) after surgical resection or definitive radiotherapy with/without chemotherapy. Recurrent disease is defined as NSCLC with same histology, same lobe that recurs within 5 years after initial definitive therapy. Patient refuses surgery is also eligible. Patient received systemic therapy is eligible.

7) Cohort 2: Performance score KPS 60-100.

8) Cohort 3: Histologically or cytologically documented NSCLC.

9) Cohort 3: Previous history of NSCLC that has been cured or stable. New development of inoperable isolated lung parenchyma lesion that has been documented histologically or cytologically as NSCLC without evidence of lymph node or mediastinal involvement (clinical stage T1-2, chest wall involvement T3, N0M0) and not eligible for cohort 1 and recurrent disease as defined in Cohort 2. This includes NSCLC happens within 5 years after initial definitive treatment of prior NSCLC, and/or is located in the different lobes.

10) (cont.) Cohort 3: Possible stage IV disease is eligible as long as it meets the criteria above since there is no definitive way to confirm it. Patient refuses surgery is eligible. Patient received systemic therapy is eligible.

11) Cohort 3: Performance score KPS 60-100.

Exclusion Criteria:1) Any tumor involving main bronchus, major vessels, heart, esophagus, trachea, carina, spinal cord.

2) Any tumor that causes collapsed lobe of lung.

3) Any tumor with maligant pleural effusion.

4) Direct evidence of hilar, mediastinal lymph node or distant metastasis based on staging work up.

5) Pregnancy. Patients (men and women) of child bearing potential should use an effective (for them) method of birth control throughout their participation in this study.

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Links
Registration Number: NCT00489008
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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