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

Phase 3

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00003831
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

Detailed Description

OBJECTIVES:

* 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 Timeline

• Study Start: 1999-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-03
• Study Completion: 2011-01
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1023

Inclusion Criteria

A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:

Pre-operative:

1. Patient must be ≥18 years of age.

2. Patient must have an ECOG/Zubrod performance status of ≤ 3.

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.

4. 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.

5. 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.

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 Z0030-specific written informed consent prior to registration and any study-related procedures.

8. If patient is a survivor of a prior cancer, the following criteria are met:

   1. Patient has undergone potentially curative therapy for all prior malignancies,
   2. 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),
   3. Patient is deemed by their treating physician to be at low risk for recurrence from prior malignancies.

Intra-operative:

1. 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.
2. 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.
3. 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.

Exclusion Criteria

A patient will NOT be eligible for inclusion in this study if ANY of the following criteria apply:

1. Patient has N2 disease determined at pre-operative mediastinoscopy or on sampling.
2. Patient has T3 or T4 tumor.
3. Patient is having only a wedge resection performed for treatment.
4. Patient has received prior chemotherapy or radiotherapy for this cancer.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	Up to 5 years

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	Up to 5 years

Trial Locations

Locations (74)

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

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

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