Treating NSCLC Minimal Stage IV With Curative Intent

A Pilot Study Treating Patients With Minimal Stage IV Non-Small Cell Lung Cancer (NSCLC) With Curative Intent

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.

Study Overview

• Status: Terminated
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Other: Induction chemotherapy and concurrent radiation; Other: Consolidation: Radiation therapy to metastatic sites

Detailed Description

In this study, patiently will be aggressively treated with 4 cycles of full dose platinum-based chemotherapy with concurrent radiation therapy to the primary tumor and identified mediastinal lymph nodal metastatic drainage. Local curative radiation will then target the oligometastatic tumor sites.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Leo W. Jenkins Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histological or cytological documented NSCLC, including squamous cell carcinoma, adenocarcinoma, large cell carcinoma including large cell neuroendocrine carcinoma and poorly differentiated (not otherwise specified - NOS) non-small cell lung cancer. Bronchial alveolar adenocarcinoma and totally resected tumors are excluded. All histology is to be reviewed at East Carolina University or designated participating center.
• Patients with Stage II-IIIB intra-thoracic disease with oligometastatic disease (hereafter referred to as "Stage IVa" disease) are eligible. Definition of Stage IVa:

Metastatic disease; either biopsy proven or with strong radiographic evidence suggesting its existence.

As determined by CT, MRI or PET no more than five distinct metastatic sites. All metastatic disease must be anatomically located in such a way as to permit a reasonable attempt at permanent ablation. Ablative measures may include surgery, stereotactic radiosurgery, and external beam therapy. Patients who meet the minimal metastatic disease requirement and who would otherwise have been staged II, IIIA or IIIB.

• Patients with tumors adjacent to a vertebral body are eligible as long as all gross disease can be encompassed in the radiation boost field.
• Patients must be ≥ 18 years of age.
• Patients with Zubrod (ECOG) performance status ≤ 2.
• Adequate hematologic function defined as: absolute neutrophil count (ANC) ≥ 1000/mm3, platelets ≥ 75,000/mm3, and hemoglobin ≥ 8 g/dL (prior to transfusions); adequate hepatic function defined as: total bilirubin ≤ 3.0 mg/dl, and adequate renal function defined as a serum creatinine level ≤ 2.0 mg/dl.
• Forced expiratory volume (FEV1) ≥ 800ml.
• Patients with weight loss < 20% over the past 3 months.
• Patients with a pleural effusion that is proven cytologically negative or is too small to tap.
• Women of childbearing potential must agree to practice effective contraception throughout the study plus four weeks.
• Pretreatment evaluations required for eligibility include:

A medical history, physical exam, and Zubrod performance status within 3 weeks prior to study entry.

Complete blodd count (CBC) with differential and platelet count, and laboratory profile must be completed within 3 weeks prior to study entry.

FEV1, CT scan of the chest or whole body PET (preferred), and a CT scan or MRI (preferred) of the brain within 4 weeks prior to study entry.

For women of childbearing potential, a serum or urine pregnancy test within a week prior to the start of protocol treatment.

Medical Oncology and Radiation Oncology consultation and approval.

• Patients must sign a study-specific consent form prior to study entry.

Exclusion Criteria:

• Prior systemic chemotherapy or radiotherapy that would interfere with delivery of treatment as outlined above as judged by the clinician.
• Cytologically malignant effusions.
• Metastatic disease beyond what is described in section 3.1.2.
• Active pulmonary infection not responsive to antimicrobial therapy.
• History of symptomatic interstitial pneumonitis.
• Significant symptomatic cardiac disease, i.e., unstable angina, uncompensated congestive heart failure, or uncontrolled cardiac ventricular arrhythmias.
• Patients with > grade 2 neuropathy.
• Evidence of malignancy in the past 2 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other in situ cancers.
• Women who are pregnant or breast feeding.
• Women of childbearing potential who are unwilling to practice effective contraception.
• Patients who currently are participating in other clinical trials and/or who have participated in other clinical trials in the previous 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Single arm study; Induction chemotherapy and concurrent radiation to primary tumor 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 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.

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Measure time of survival from enrollment to death from any cause, assessed up to 100 months.	Anticipated medial survival time is 8 - 10 months, however, all participants will be followed until death, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New metastatic disease	Measure of time from patient entry to time of new disease or progression of disease or date of death from any cause, whichever came first, assessed up to 100 months.	Anticipated time to progression is unknown, however, all patients will be followed for survival, up to 100 months.

Collaborators and Investigators

• Sponsor: Leo W. Jenkins Cancer Center
• Collaborators: East Carolina University
• Investigators: Principal Investigator: Paul Walker, MD, PhD, Brody School of Medicine ar East Carolina University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): August 22, 2017
• Study Completion (Actual): August 22, 2017

Study Registration Dates

• First Submitted: August 26, 2013
• First Submitted That Met QC Criteria: February 3, 2014
• First Posted (Estimate): February 4, 2014

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: LJCC 2011-01