Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer

NCT01797471 | Terminated Results DMC

• 1 other identifier: 20100446
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase I clinical trial. The investigators hypothesize that the addition of a one-time single fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity above that expected with standard-dose concurrent chemotherapy and radiation alone.

Conditions

Non-Small Cell Lung Cancer; NSCLC

Keywords

Non-Small Cell Lung Cancer; NSCLC; Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Treatment-related Toxicity in Study Participants

  Rate of treatment-related toxicity (serious adverse events, adverse events, etc.) in study participants. Toxicity will be assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.

  Up to 12 months

Secondary Outcomes (5)

• Rate of Study Participants Achieving Complete or Partial Response Via CT RECIST Response Criteria

  Assessed up to 2 years

• Rate of Study Participants Achieving Complete or Partial Response Via PET Response Criteria

  Assessed up to 2 years

• Rate of Loco-regional Failure in Study Participants

  Assessed up to 2 years

• Progression-Free Survival (PFS)

  Assessed up to 2 years

• Overall Survival (OS)

  Assessed up to 2 years

Study Arms (1)

LEAD RT

EXPERIMENTAL

* Lattice Extreme Ablative Dose (LEAD) Radiation Therapy (RT) on Day 1 at dose of 18 Gy followed by; * Conventionally fractionated radiation therapy beginning on day 2 at 2 Gy per fraction for 30 fractions for a total dose of 60 Gy; * Conventional Platinum Chemotherapy Doublet at discretion of treating physician beginning on day 2.

Radiation: Lattice Extreme Ablative Dose (LEAD) Radiation Therapy

Interventions

Lattice Extreme Ablative Dose (LEAD) Radiation Therapy RADIATION

A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1

Also known as: LEAD Radiotherapy, LEAD Radiation Therapy

LEAD RT

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically documented stage III non-small cell lung cancer including squamous cell, adenocarcinoma, large cell carcinoma and poorly differentiated non-small cell lung cancer.
• Patients must have a minimum of 4 cm of measurable disease in any one continuous dimension as seen on diagnostic CT scan.
• Pulmonary function tests with forced expiratory volume in 1 second (FEV1) ≥1.45 liters/second.
• Patients must be 21 years of age or older. There is no maximum age restriction.
• Patients must have a Zubrod performance status of 0 or 1.
• Patients must have normal organ and marrow function as defined below:
• leukocyte \> 3,000/:I
• absolute neutrophil count \>1,500/:I
• platelets \>100,000/:I
• bilirubin within normal institutional limits
• Aspartate transaminase (AST/SGOT)/Alanine transaminase (ALT/SGPT) 2.5 X institutional upper limit of normal
• Creatinine within normal institutional limits OR creatinine clearance \> 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
• Patients must have weight loss ≤ 10% over the past three months.
• Women of child-bearing potential and men will be asked to use adequate contraception.
• Patients must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Patients may not have had prior thoracic radiation at any time, or prior chemotherapy for the study cancer at any time.
• Patients may not be receiving any other investigational agents for the study cancer.
• Patients may not have evidence of brain metastases on baseline CT scan or MRI.
• Patients may not have measurable gross disease in the thorax \<4 cm in any one continuous dimension.
• Patients may not have a cytologically positive pleural effusion.
• Patients may not have a prior invasive malignancy (unless disease-free for at least 3 years).
• Patients may not have had surgical resection of the present cancer.
• Women who are pregnant or breastfeeding will be excluded.
• Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients must not have severe lung disease defined by a history of severe chronic obstructive pulmonary disease (COPD) requiring 3 or more hospitalizations over the past year, or history of interstitial pneumonitis.
• Patients must not have any concurrent active malignancy.
• Patients must not have evidence of metastatic disease.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Lead; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals; Therapeutics

Limitations and Caveats

A minimum sample size of 10 study participants was required for the analysis of most outcome measures. Minimum enrollment was not met, therefore, the data for these applicable outcome measures were not analyzed.

Results Point of Contact

• Title: Jean L. Wright MD
• Organization: University of Miami

jwright3@med.miami.edu

305-243-5965

Study Officials

• Jean L Wright, MD

  University of Miami Sylvester Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: February 22, 2013
• Study Start: March 1, 2013
• Primary Completion: May 31, 2013
• Study Completion: November 6, 2013
• Last Updated: December 21, 2017
• Results First Posted: December 21, 2017

Record last verified: 2017-11

Locations

US (1)