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Study Summary
No. 2007-0870:.......Lung......Jack Roth......Thoracic & Cardiovascular
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Study Summary Title
Study Summary
Number:
2007-0870
Study Title:International randomized study to Compare CyberKnife® Stereotactic Radiosurgery with surgical resection in stage I non-small cell lung cancer
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Physician New Patient Referral
Name:Jack RothPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Thoracic & CardiovascularReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-9152
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:Accuray Incorporated
Phase of Study:N/AReturn
Visit:
Every 6 months for 2 years then yearly for the next 3 years
Treatment
Agents:
Radiation
Surgical Procedure
Home Care:None
Treatment Loc:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:
For patients randomized to the surgery arm 5 - 10 days. For patients randomized
to the CyberKnife arm there will be 3 - 4 clinic visits over 3 - 10 days for
the treatment.
Description/
Intervention:
Unavailable
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Study Objectives / Outcomes
Primary Goal:
To compare overall survival at 3 years

Secondary goals:

1. To compare disease specific survival at 3 years.
2. To compare 3 year progression free survival at the treated primary tumor site
3. To compare grade 3 and above acute and/or chronic toxicities.
4. To evaluate predictive value of pre and post treatment PET scan in clinical outcome.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:04/05/2010
Study Type:Observational
Recruitment Status:Closed
Projected Accrual:420
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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) Histological confirmation of non-small cell cancer will be required by either biopsy or cytology. The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma with or without BAC features, large cell carcinoma with or without neuroendocrine features, neuroendocrine carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified.

2) Eligible patients must have appropriate staging studies identifying them as specific subsets of the revised IASLC stage IA based on the following combination of TNM staging: T1, N0, M0.

3) A PET/CT scan is required. Patients with hilar or mediastinal lymph nodes with short axis diameter </= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm short axis diameter of hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. Solitary pulmonary lesions </= 4mm will not be considered significant.

4) Patients must be considered a candidate for surgical resection of the primary tumor. Standard justification for deeming a patient medically operable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline FEV1 > 40% predicted, post-operative predicted FEV1 > 30% predicted, diffusion capacity > 40% predicted, absent baseline hypoxemia and/or hypercapnia, exercise oxygen consumption > 50% predicted, absent severe pulmonary hypertension, absent severe cerebral, cardiac, or peripheral vascular disease, and absent severe chronic heart disease.

5) Patients must be >/= 18 years of age.

6) The patient's Zubrod performance status must be Zubrod 0-2.

7) PET/CT scan to include both lungs, the mediastinum, and adrenal glands; Primary tumor dimension will be measured on diagnostic CT and again on simulation CT. Must be done within 8 weeks prior to study entry. If a PET/CT scan cannot be performed, the patient can be eligible if a mediastinoscopy or endobronchial ultrasound (EBUS) guided biopsy of the mediastinal lymph nodes is performed.

8) MRI or CT scans of Brain if there are symptoms or signs suggesting brain metastases, must be done within 8 weeks prior to study entry.

9) Invasive Mediastinal Staging - All patients with CT and/or PET evidence of hilar (level 10) or mediastinal lymph nodes > 1.0 cm in the shortest diameter must be staged by either cervical mediastinoscopy, esophageal endoscopic ultrasound guided biopsy, or endobronchial ultrasound guided biopsy.

10) Patients must sign a study-specific consent form.

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

Exclusion Criteria:1) Patients with primary tumors > 3 cm.

2) Patients with well-differentiated neuroendocrine carcinoma (carcinoid tumor).

3) Direct evidence of regional or distant metastases after appropriate staging studies, or synchronous primary or prior malignancy in the past 5 years other than nonmelanomatous skin cancer or in situ cancer.

4) Previous lung or mediastinal radiotherapy.

5) Plans for the patient to receive other concomitant local therapy (including standard fractionated radiotherapy and surgery) while on this protocol except at disease progression.

6) Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.

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Links
Registration Number: NCT00840749
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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