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A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer


Phase 1
21 Years
N/A
Not Enrolling
Both
Non-Small Cell Lung Cancer, NSCLC

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Trial Information

A Phase 1 Study for Evaluating the Safety of Lattice Extreme Ablative Dose (LEAD) Radiotherapy Followed by Standard-Dose Chemoradiation for Patients With Bulky Stage III Non-Small Cell Lung Cancer


Inclusion Criteria:



- 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 measureable disease in any one continuous
dimension as seen on diagnostic CT scan.

- Pulmonary function tests with 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/:1

- platelets >100,000/:1

- bilirubin within normal institutional limits

- AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal

- Creatinine within normal institutional limits OR creatinine clearance > 60
mL/min/1.73 m2 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.

Exclusion Criteria:

- 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 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of treatment-related adverse events experienced by participants

Outcome Description:

Toxicity will be graded by CTCAE v 4.0. The two toxicities that will be monitored as primary endpoints are esophagitis and pneumonitis.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Jean L Wright, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20100446

NCT ID:

NCT01797471

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • NSCLC
  • Non-Small Cell Lung Cancer
  • NSCLC
  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136