Lymph Node Removal in Treating Patients With Stage I or Stage II Non-small Cell Lung Cancer

Completed · Phase 3

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID: NCT00003831
Run by: Alliance for Clinical Trials in Oncology
People needed: 1023
Starts: 1999-07-01
Expected to finish: 2011-01-01
Last updated by the study team: 2016-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
Pre-operative:
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.
Intra-operative:
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.

You may not qualify if…

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.

Where it is running

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center — Los Angeles, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center — Orange, California, United States
Huntington Cancer Center at Huntington Hospital — Pasadena, California, United States
UCSF Comprehensive Cancer Center — San Francisco, California, United States
Stanford University Medical Center — Stanford, California, United States
Veterans Affairs Medical Center - Gainesville — Gainesville, Florida, United States
Shands Cancer Center at the University of Florida — Gainesville, Florida, United States
Holmes Regional Medical Center — Melbourne, Florida, United States
Jackson Memorial Hospital — Miami, Florida, United States
Emory University School of Medicine — Atlanta, Georgia, United States
Medical Center of Central Georgia — Macon, Georgia, United States
University of Chicago Cancer Research Center — Chicago, Illinois, United States
Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
Loyola University Medical Center — Maywood, Illinois, United States
Edward Hospital Cancer Center — Naperville, Illinois, United States
St. John's Hospital — Springfield, Illinois, United States
Southern Illinois University School of Medicine — Springfield, Illinois, United States
Central Baptist Hospital — Lexington, Kentucky, United States
Jewish Hospital — Louisville, Kentucky, United States
Medical Center of Southwest Louisiana — Lafayette, Louisiana, United States
Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
Rhode Island Hospital — Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Hurley Medical Center — Flint, Michigan, United States
Mobile Infirmary Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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