Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00003831|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 14, 2016
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RATIONALE: Surgical removal of all lymph nodes in the chest may kill cancer cells that have spread from tumors in the lung. It is not yet known whether complete removal of all lymph nodes in the chest is more effective than removal of selected lymph nodes in treating patients who have stage I or stage II non-small cell lung cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete removal of all lymph nodes in the chest with that of selected removal of lymph nodes during lung cancer surgery in treating patients who have stage I or stage II non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Procedure: conventional surgery||Phase 3|
- Compare whether a complete mediastinal lymph node dissection versus mediastinal lymph node sampling improves overall survival of patients with N0 or non-hilar N1 non-small cell lung cancer undergoing resection.
- Compare these two methods with reference to identification of occult mediastinal lymph node involvement.
- Compare the effect of these two methods on operative time and duration of postoperative complications, including chest tube drainage and length of hospitalization for these patients.
- Compare the effect of these two methods on local recurrence free survival and local regional recurrence free survival of these patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1023 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Trial of Mediastinal Lymph Node Sampling Versus Complete Lymphadenectomy During Pulmonary Resection in the Patient With N0 and N1 (Less Than Hilar) Non-Small Cell Carcinoma|
|Study Start Date :||July 1999|
|Actual Primary Completion Date :||March 2006|
|Actual Study Completion Date :||January 2011|
Experimental: Lymph node sampling
Patients undergo pulmonary resection. No additional lymph nodes are removed. Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.
Procedure: conventional surgery
Active Comparator: Lymph node dissection
Patients undergo removal of nearly all of the lymph nodes from the central part of the chest between the lungs, followed by pulmonary resection. Patients are followed at 4, 6, 8, 12, 18, 24, and 36 months and then annually thereafter until death.
Procedure: conventional surgery
- Overall survival [ Time Frame: Up to 5 years ]
- Disease-free survival [ Time Frame: Up to 5 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
- Patient must be ≥18 years of age.
- Patient must have an ECOG/Zubrod performance status of ≤ 3.
- Patient must have tissue diagnosis of a clinically resectable T1 or T2, N0 or non-hilar N1, M0 NSCLC (squamous cell carcinoma, large cell carcinoma or adenocarcinoma including bronchoalveolar carcinoma) established prior to randomization. NOTE: A patient without a pre-operative tissue diagnosis, but with clinically suspected NSCLC that fits the above criteria is eligible provided the tissue diagnosis is confirmed intraoperatively.
- Patient must have pre-operative imaging procedure, CT scan of the chest and upper abdomen to include liver and adrenal glands to determine eligibility, within 60 days of the date of the pulmonary resection.
- Patient that has not had a mediastinoscopy should have no mediastinal adenopathy on the CT of the chest defined as no lymph node > 1 cm in the shortest axis.
- 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.
- Patient, or patient's legally acceptable representative, must provide a signed and dated Z0030-specific written informed consent prior to registration and any study-related procedures.
If patient is a survivor of a prior cancer, the following criteria are met:
- Patient has undergone potentially curative therapy for all prior malignancies,
- No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for effectively treated basal cell or squamous carcinoma of the skin, carcinoma in-situ of the cervix that has been effectively treated by surgery alone, or lobular carcinoma in-situ of the ipsilateral or contralateral breast treated by surgery alone),
- Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.
- Patient with right-sided lesions must have at least nodal stations #2R, 4R, 7 and 10 R examined. If the nodes are found, they must be sampled and proven negative by frozen section.
- Patient with left-sided lesions must have at least nodal stations #5, 6, 7 and 10L examined. If the nodes are found, they must be sampled and proven negative by frozen section.
- Any other suspicious mediastinal or hilar nodes must be sampled and proven negative by frozen section. Levels 2, 4 and 7 need not be re-sampled if they were sampled at a mediastinoscopy done within 60 days of thehoracotomy.
A patient will NOT be eligible for inclusion in this study if ANY of the following criteria apply:
- Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.
- Patient has T3 or T4 tumor.
- Patient is having only a wedge resection performed for treatment.
- Patient has received prior chemotherapy or radiotherapy for this cancer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003831
|Study Chair:||Mark S. Allen, MD||Mayo Clinic|
|Responsible Party:||Alliance for Clinical Trials in Oncology|
|Other Study ID Numbers:||
CDR0000066988 ( Registry Identifier: NCI Physician Data Query )
|First Posted:||January 27, 2003 Key Record Dates|
|Last Update Posted:||July 14, 2016|
|Last Verified:||July 2016|
stage I non-small cell lung cancer
stage II non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases