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Study Summary
No. ACOSOG-Z0030:.......Lung......Ara Vaporciyan......Thoracic & Cardiovascular
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Study Summary Title
Study Summary
Number:
ACOSOG-Z0030
Study Title:Randomized Trial of Mediastinal Lymph Node Sampling versus Complete Lymphadenectomy During Pulmonary Resection in the Patient with N0 or N1 (less than hilar) Non- Small Cell Carcinoma
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Physician New Patient Referral
Name:Ara VaporciyanPatients 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:713-745-4547
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:N/AReturn
Visit:
Return visits will be at 4 months, 8 months, 12 months, 18 months, 24 months,
36 months, and yearly after 36 months after surgery.
Treatment
Agents:
NoneHome Care:None
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Patients will be hospitalized for 7 days for surgery.
Description/
Intervention:
The goal of this clinical research study is to learn if removing nearly all of
the mediastinal lymph nodes (lymph nodes in the central part of the chest)
results in better overall survival when compared to only sampling a few of
these lymph nodes in patients undergoing surgery for non-small cell lung
cancer.
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Study Objectives / Outcomes
Primary: To evaluate whether complete mediastinal lymph node dissection results in better overall survival when compared to mediastinal lymph node sampling in the patient undergoing resection for N0 or non-hilar N1 NSCLC.

Secondary: 1. To compare mediastinal lymph node sampling to complete mediastinal lymph node dissection with reference to identification of occult mediastinal lymph node involvement.

2.To assess whether complete mediastinal lymph node dissection adversely affects the patient in reference to operative time, post-operative complications, duration of chest drainage, and length of hospitalization, as compared to mediastinal lymph node sampling.

3. To evaluate whether complete mediastinal lymph node dissection improves local recurrence-free survival and local-regional recurrence-free survival as compared to mediastinal lymph node sampling.

4.To contribute primary NSCLC lung tumor tissue, non-malignant lung tissue, and peripheral blood cells to the American College of Surgeons Oncology Group (ACOSOG) Central Specimen Bank.
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Study Status Information
Study Activation / Registration Date:02/17/2003
IRB Review and Approval Date:12/04/2002
Study Type:Therapeutic
Recruitment Status:Terminated
Projected Accrual:1000
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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) Patient must be > or = 18 years of age with ECOG PS of < or = 3.

2) Have tissue diagnosis of a clinically resectable T1 or T2 , N0 or non-hilar N1, M0 NSCLC (squamous carcinoma, large cell carcinoma, or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization.

3) A patient without a preoperative tissue diagnosis, but with clinically suspected NSCLC that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively.

4) Must have CT scan of the chest and upper abdomen to include the liver and adrenal glands within 60 days of the date of the pulmonary resection.

5) Patient that has not had a mediastinoscopy should have no mediastinal adenopathy on CT of the chest defined as no lymph node > 1 cm in the shortest axis.

6) Patient is a candidate for a complete resection of the carcinoma via pneumonectomy, lobectomy, bilobectomy, or anatomic segmentectomy with or without sleeve resection, as noted in the surgical plan.

7) Patient or patient's legally acceptable representative must provide a signed and dated informed consent prior to registration and study related procedures.

8) If patient is a survivor of a prior cancer, the following must be met: a) patient has undergone potentially curative therapy for all prior malignancies, b) no evidence of prior malignancy for at least 5 years except for effectively treated basal or squamous cell carcinoma of the skin, carcinoma in-situ of the cervix or carcinoma in-situ of the breast treated by surgery alone and c) patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

9) Patient with right-sided lesions must have at least # 2R, 4R, 7 and 10R examined intraoperatively. If the nodes are found, they must be sampled and proven negative by frozen section.

10) Patient with left-sided lesions must have at least nodal stations # 5, 6, 7, and 10L examined intra-operatively. If the nodes are found, they must be sampled and proven negative by frozen section.

Exclusion Criteria:1) N2 disease determined at preoperative mediastinoscopy or on sampling.

2) T3 or T4 tumor.

3) Patient having wedge resection only.

4) Received prior chemotherapy or radiotherapy for this cancer.

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Links
Registration Number: NCT00003831
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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