Clinical trial · Interventional
Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): After completion of Phase I, it was decided not to initiate Phase II of the study.
Summary
Brief summary (as posted)
The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Ablative Body Radiation (SABR) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Phase 1/Dose Level 1
- description
- 11 Gy will be given in 5 fractions for a total dose of 55 Gy
- interventionNames
- Radiation: Stereotactic Ablative Body Radiation (SABR)
- type
- EXPERIMENTAL
- label
- Phase 1/Dose Level 2
- description
- 12 Gy will be given in 5 fractions for a total dose of 60 Gy
- interventionNames
- Radiation: Stereotactic Ablative Body Radiation (SABR)
- type
- EXPERIMENTAL
- label
- Phase 1/Dose Level 3
- description
- 13 Gy will be given in 5 fractions for a total dose of 65 Gy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria 1. Age ≥ 18 at time of consent. 2. Ability to provide written informed consent and HIPAA authorization. 3. Pathological diagnosis of squamous cell carcinoma of the lung. 4. Staging PET/CT (invasive mediastinal staging strongly encouraged but not required). 5. Tumors \< 7cm 6. Any location eligible for SBRT (including, but not limited to, peripheral, chest wall abutting and central tumors) 7. N0 M0 disease 8. Plan to undergo four or five fraction SABR 9. Baseline PFTs available within 6 months of treatment start or will be obtained prior to treatment start (no finding will exclude patient from enrollment in trial) Exclusion Criteria 1. Previous radiation therapy to the lung per investigator discretion. 2. Inability to comply with treatment per investigator discretion. 3. Inability to follow standard of care follow up recommendations per investigator discretion. 4. KPS\<40
References
Publications (0)
Data not yet available