Treating NSCLC Minimal Stage IV With Curative Intent

NCT02054819 | Terminated Phase 2 DMC

• 1 other identifier: LJCC 2011-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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

Non-small Cell Lung Cancer

Keywords

lung cancer; NSCLC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• New metastatic disease

  Anticipated time to progression is unknown, however, all patients will be followed for survival, up to 100 months.

Study Arms (1)

Single arm study

OTHER

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; Other: Consolidation: Radiation therapy to metastatic sites

Interventions

Induction chemotherapy and concurrent radiation OTHER

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

Single arm study

Consolidation: Radiation therapy to metastatic sites OTHER

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).

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leo W. Jenkins Cancer Center: lead
• East Carolina University: collaborator

Study Sites (1)

Leo W. Jenkins Cancer Center

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Induction Chemotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Remission Induction

Study Officials

• Paul Walker, MD, PhD

  Brody School of Medicine ar East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: February 4, 2014
• Study Start: June 1, 2013
• Primary Completion: August 22, 2017
• Study Completion: August 22, 2017
• Last Updated: August 21, 2019

Record last verified: 2018-03

Locations

US (1)