N/A
N=55
Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy
Non-small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03623334 ↗Enrolled (actual)
55
Serious AEs
23.6%
Results posted
May 2021
Primary outcome: Primary: Number of Participants With Dose Limiting Toxicity — 1; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Image-Guided Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity |
1; 1; 1 | — |
| SECONDARY Number of Participants With Local Regional Tumor Control at 3 Months |
4; 11; 11 | — |
| SECONDARY Number of Participants With Local Regional Tumor Control at 6 Months |
2; 5; 8 | — |
| SECONDARY Number of Participants With Local Regional Tumor Control at 9 Months |
2; 4; 5 | — |
| SECONDARY Number of Participants With Local Regional Tumor Control at 12 Months |
1; 1; 4 | — |
| SECONDARY Number of Participants With Local Regional Tumor Control at 16 Months |
1; 0; 2 | — |
| SECONDARY Number of Participants With Local Regional Tumor Control at 20 Months |
1; 0; 0 | — |
| SECONDARY Overall Survival at 6 Months |
11; 13; 12 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03623334). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.