Clinical trial · Interventional
Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy
Phase I Study of Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-IV Non-Small Cell Lung Cancer and Poor Performance Status
NCT03623334CI-TRIAL-00051597completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Image-Guided Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Dose Level A: IGRT 3.33Gy x 15 Fractions
- description
- 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
- interventionNames
- Radiation: Image-Guided Radiation Therapy
- type
- EXPERIMENTAL
- label
- Dose Level B: IGRT 3.67Gy x 15 Fractions
- description
- 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
- interventionNames
- Radiation: Image-Guided Radiation Therapy
- type
- EXPERIMENTAL
- label
- Dose Level C: IGRT 4.00Gy x 15 Fractions
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients must be willing and capable to provide informed consent to participate in the protocol. 2. 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. 3. Patients must have the potential for benefit from local therapy (at the discretion of the investigator). 4. 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 5. Age ≥ 18. 6. The tumor must be ineligible for definitive surgical resection. 7. The tumor must be ineligible for stereotactic body radiation therapy. 8. Patients must have measurable or evaluable disease. 9. Women of childbearing potential and male participants must agree to use an effective method of contraception. 10. Patients must sign study specific informed consent prior to study entry. 11. Patients must complete all required pretreatment evaluations Exclusion Criteria: 1. Evidence of small cell histology. 2. Tumor eligible for definitive surgical resection. 3. Tumor eligible for definitive stereotactic body radiation therapy. 4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields. 5. Chemotherapy given within one week of study registration. 6. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
References
Publications (0)
Data not yet available
No reference posted for this study.