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Treating NSCLC Minimal Stage IV With Curative Intent

NCT02054819 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2019-08-21

No results posted yet for this study

Summary

It is the hypothesis of this protocol that a subset of NSCLC patients with stage IVa disease can benefit from curative therapy and extends beyond the very limited subset of oligometastatic patients that have already been studied.

Conditions

Interventions

OTHER

Induction chemotherapy and concurrent radiation

Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions

OTHER

Consolidation: Radiation therapy to metastatic sites

At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. For brain, 2.5 Gy x 14 to whole brain to follow stereotactic radiosurgery (SRS).

Sponsors & Collaborators

  • East Carolina University

    collaborator OTHER

  • Leo W. Jenkins Cancer Center

    lead OTHER

Principal Investigators

  • Paul Walker, MD, PhD · Brody School of Medicine ar East Carolina University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2017-08-22
Completion
2017-08-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02054819 on ClinicalTrials.gov