Phase 3
N=1,047
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
Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00003901 ↗Enrolled (actual)
1,047
Serious AEs
—
Results posted
Feb 2017
Primary outcome: Primary: Overall Survival in Lymph Nodes Examined Patients — NA; NA years — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- immunohistochemistry staining method (Other); biopsy (Procedure); surgery (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival in Lymph Nodes Examined Patients |
NA; NA | 0.007 sig |
| PRIMARY Overall Survival in Bone Marrow Examined Patients |
NA; NA | 0.886 |
| SECONDARY Disease-Free Survival in Lymph Nodes Examined Patients |
NA; NA | 0.009 sig |
| SECONDARY Disease-Free Survival in Bone Marrow Examined Patients |
NA; NA | 0.332 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00003901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.