CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,310 enrolled
Drug / intervention
immunohistochemistry staining method +2 moreother
Likely dose
Not stated in record
Key inclusion· 8
  • ✓Age ≥18 years
  • ✓ECOG/Zubrod status <3
  • ✓Clinically resectable NSCLC (squamous cell, adenocarcinoma, or large cell), clinical Stage I, IIa, IIb or IIIa
  • ✓N1 or N2 disease
Key exclusion· 5
  • ✕Evidence of pleural effusion on physical examination, chest X-ray, or CT
  • ✕Prior ipsilateral thoracotomy or thoracoscopy within 5 years
  • ✕Prior chemotherapy or radiotherapy for this cancer
  • ✕Poor surgical risk due to non-malignant systemic disease (cardiovascular, renal, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00003901
NCT00003901Phase 3Completed
CompareCT.gov

A Prospective Study of the Prognostic Significance of Occult Metastases in the Patient With Resectable Non-Small Cell Lung Carcinoma

Alliance for Clinical Trials in Oncology·interventional·Posted Jan 27, 2003·Updated Feb 16, 2017

In Brief

A Phase 3 clinical trial evaluating immunohistochemistry staining method, biopsy, and 1 other intervention for Lung Cancer. Completed, enrolled 1,310 participants across 58 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Cancer
CountriesCanada, United States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJul 1, 1999
Primary CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 23.4 years ago

Interventions

immunohistochemistry staining methodother

biopsyprocedure

surgeryprocedure