Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy

NCT03623334 | Completed Results DMC

• 1 other identifier: STU 072010-050
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to determine whether daily image guidance and motion assessment/control will allow treatment of poor performance status patients with stage II-IV NSCLC, who would benefit from local therapy, with an accelerated course of hypofractionated radiation therapy.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Dose Limiting Toxicity

  A dose limiting toxicity (DLT) is defined as treatment-related (definitely and probably, but not possibly related to treatment\*) grade 3 adverse events (per CTCAE, v.3.0, with the exception of pulmonary function tests)

  90 days after start of treatment up to 1 year

Secondary Outcomes (7)

• Number of Participants With Local Regional Tumor Control at 3 Months

  3 months

• Number of Participants With Local Regional Tumor Control at 6 Months

  6 months

• Number of Participants With Local Regional Tumor Control at 9 Months

  9 months

• Number of Participants With Local Regional Tumor Control at 12 Months

  12 months

• Number of Participants With Local Regional Tumor Control at 16 Months

  16 months

Study Arms (3)

Dose Level A: IGRT 3.33Gy x 15 Fractions

EXPERIMENTAL

Image-guided radiation therapy (IGRT) dose of 3.33Gy for 15 fractions (total dose = 50 Gy) which is given over the course of about 3 weeks

Radiation: Image-Guided Radiation Therapy

Dose Level B: IGRT 3.67Gy x 15 Fractions

EXPERIMENTAL

Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 55 Gy) which is given over the course of about 3 weeks

Radiation: Image-Guided Radiation Therapy

Dose Level C: IGRT 4.00Gy x 15 Fractions

EXPERIMENTAL

Image-guided radiation therapy (IGRT) dose of 3.67Gy for 15 fractions (total dose = 60 Gy) which is given over the course of about 3 weeks

Radiation: Image-Guided Radiation Therapy

Interventions

Image-Guided Radiation Therapy RADIATION

Radiotherapy to a potent tumorcidal dose

Dose Level A: IGRT 3.33Gy x 15 Fractions; Dose Level B: IGRT 3.67Gy x 15 Fractions; Dose Level C: IGRT 4.00Gy x 15 Fractions

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be willing and capable to provide informed consent to participate in the protocol.
• Patients must have appropriate staging studies identifying them as AJCC stage II, III or IV non small cell lung cancer, \[according to AJCC Staging, 6th edition; see appendix III\], or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology.
• Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
• Patient must have a Zubrod performance status of 2 or greater Or Patient must have had \>10% weight loss in the past 6 months Or Patient is not eligible for concurrent chemoradiation as determined by a Medical Oncologist and Radiation Oncologist
• Age ≥ 18.
• The tumor must be ineligible for definitive surgical resection.
• The tumor must be ineligible for stereotactic body radiation therapy.
• Patients must have measurable or evaluable disease.
• Women of childbearing potential and male participants must agree to use an effective method of contraception.
• Patients must sign study specific informed consent prior to study entry.
• Patients must complete all required pretreatment evaluations

You may not qualify if:

• Evidence of small cell histology.
• Tumor eligible for definitive surgical resection.
• Tumor eligible for definitive stereotactic body radiation therapy.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
• Chemotherapy given within one week of study registration.
• Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Limitations and Caveats

Planned statistical analysis was not able to be performed due to the poor overall survival of the study population.

Results Point of Contact

• Title: Sarah Hardee
• Organization: UT Southwestern Medical Center

sarah.hardee@utsouthwestern.edu

214-648-1836

Study Officials

• Robert Timmerman

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: August 9, 2018
• Study Start: October 5, 2009
• Primary Completion: November 2, 2012
• Study Completion: February 10, 2018
• Last Updated: May 4, 2021
• Results First Posted: May 4, 2021

Record last verified: 2021-04