Prognostic Study of Metastases in Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Can Be Removed by Surgery

Completed · Phase 3

Conditions studied: Lung Cancer

In brief

RATIONALE: Prognostic testing for early signs of metastases may help doctors detect metastases early and plan more effective treatment. PURPOSE: Phase III trial to study the relationship between early signs of metastases and survival in patients who have stage I, stage II, or stage III non-small cell lung cancer that can be removed by surgery.

Key facts

Study ID

NCT00003901

Run by

Alliance for Clinical Trials in Oncology

People needed

1310

Starts

1999-07-01

Expected to finish

2011-10-01

Last updated by the study team

2017-02-16

Who can join

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

You may qualify if…

• Patient must be ≥ 18 years old.
• Patient must have ECOG/Zubrod status < 3.
• Patient must have clinically resectable, NSCLC (squamous cell, adenocarcinoma, or large cell) and be clinical Stage I, IIa, IIb or IIIa, according to the 1998 staging system of the American Joint Commission on Cancer for lung cancer.
• Patient must have N1 or N2 disease. NOTE: Patient must undergo mediastinoscopy if preoperative studies suggest N3 disease.
• Patient must have a pathologic diagnosis (pre-operative or intra-operative) of NSCLC prior to registration.
• Patient must be anticipated to have a thoracotomy with the intention of a curative resection for primary NSCLC. NOTE: The preoperative assessment of resectability should, at a minimum, include a CT scan of the chest and upper abdomen, including the adrenal glands, within 60 days prior to registration.
• Patient must be medically fit for surgery.
• Patient must be a candidate for complete resection of the carcinoma via pneumonectomy, bilobectomy, lobectomy, or anatomic segmentectomy with or without sleeve resection.
• Patient or the patient's legally acceptable representative must provide a signed and dated written informed consent prior to registration and any study-related procedures.
• Patient must be available for follow-up.
• If the patient is a survivor of a prior cancer, all of the following criteria must apply:
• 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.

You may not qualify if…

• Patient has evidence of pleural effusion by physical assessment, lateral chest x-ray, or by chest CT scan.
• Patient has had ipsilateral thoracotomy or thoracoscopy within the past 5 years.
• Patient has received prior chemotherapy or radiotherapy for this cancer.
• Patient is considered a poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.) that would preclude the treatment options.
• Patient for whom the surgeon plans to perform only a wedge resection for treatment.

Where it is running

• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles, California, United States
• Huntington Cancer Center at Huntington Hospital — Pasadena, California, United States
• University of California Davis Cancer Center — Sacramento, California, United States
• UCSF Comprehensive Cancer Center — San Francisco, California, United States
• University of Colorado Health Sciences Center - Denver — Denver, Colorado, United States
• Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Bayfront Medical Center — St. Petersburg, Florida, United States
• University of Chicago Cancer Research Center — Chicago, Illinois, United States
• Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
• Cancer Institute at St. John's Hospital — Springfield, Illinois, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Holden Comprehensive Cancer Center at University of Iowa — Iowa City, Iowa, United States
• Jewish Hospital — Louisville, Kentucky, United States
• McLaren Regional Cancer Center — Flint, Michigan, United States
• Hurley Medical Center — Flint, Michigan, United States
• William Beaumont Hospital - Royal Oak — Royal Oak, Michigan, United States
• Siteman Cancer Center — St Louis, Missouri, United States
• Veterans Affairs Medical Center - Omaha — Omaha, Nebraska, United States
• Creighton University School of Medicine — Omaha, Nebraska, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• James P. Wilmot Cancer Center at University of Rochester Medical Center — Rochester, New York, United States
• Long Island Cancer Center at Stony Brook University Hospital — Stony Brook, New York, United States
• Providence Cancer Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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