Clinical trial · Interventional
Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients
A Single Arm Phase II Study of Hypofractionated Radiotherapy Alone in Locally Advanced Nonsmall Cell Lung Cancer Patients Who Decline or Are Ineligible for Surgery or Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accruals
Summary
Brief summary (as posted)
The purpose of this research study is to find out what effects (good or bad) may come from a new way of doing radiation therapy for lung cancer. This study is for patients who are not able to get surgery or chemotherapy with their radiation. The way of doing radiation therapy in this trial is called hypofractionated radiation therapy which is a standard approach, but this study allows the actual tumor to get an extra radiation dose while still protecting the organs that are near the tumor.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsmall Cell Lung Cancer, Stage II | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Nonsmall Cell Lung Cancer Stage III | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Radiation Therapy | Drug | — | UNRESOLVED |
| Radiation Boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Radiation Therapy
- description
- Hypofractionated radiation therapy will be delivered to all participants. The radiation will be planned in a special way to give the biggest parts of the tumors that are the most difficult to control a little more radiation every day than the lower risk areas.
- interventionNames
- Drug: Hypofractionated Radiation Therapy
- Radiation: Radiation Boost
Primary outcomes (1)
- measure
- Presence or Absence of In-Field Progression
- timeFrame
- At 2 years
- description
- In-field progression is defined as growth of the targeted lesions beyond the treated volume. The treated volume will be defined as the 28.75 Gy isodose line (50% of 57.5 Gy). Pathologic confirmation of tumor progression is preferred, but can be determined radiographically by Multidisciplinary Thoracic Oncology Program consensus if biopsy of the lesion in question is not feasible or safe. Investigators will compare the proportion of the sample with any in-field progression at 2 years to the historical control proportion of 0.5, using a one-sample z-test.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of non-small cell lung cancer by either biopsy or cytology * American Joint Committee on Cancer (AJCC) 8th Edition Stage II-III or ultracentral Stage IB disease as determined by PET/CT and MRI Brain * Ultracentral disease will be defined as edge of gross visible tumor within 1.0 cm of the proximal bronchial tree. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3 * Participant is not eligible for or has declined surgical resection or stereotactic body radiotherapy as determined by the treating physician * Participant is not eligible for or has declined concurrent chemotherapy as determined by the treating physician * While investigators expect it to be an uncommon event, sequential use of systemic therapy after completion of radiation therapy is permissible if the participant's status improves such that they become eligible for such therapies, per the discretion of a multidisciplinary tumor board. * Negative serum or urine pregnancy test within 2 weeks of the date of enrollment for women of child-bearing potential. * Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * History of previous thoracic radiotherapy with the exception of prior radiotherapy for breast cancer without overlap of the fields with the cancer to be treated. * Prior systemic therapy or surgery for the study cancer. * Prior malignancy within the past two years except for non-melanoma skin cancer, prostate cancer, or any in-situ malignancy. * Receipt of anti-angiogenic therapy, such as bevacizumab, within 6 months of enrollment. * Pregnant women are excluded from this study because radiation therapy has known potential for teratogenic or abortifacient effects.
References
Publications (0)
Data not yet available