Clinical trial · Interventional
Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Phase III Randomized Study of Standard Versus Accelerated Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer and Poor Performance Status
- 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 an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional radiation | Radiation | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiation Therapy
- description
- Arm A:Image-Guided Radiation Therapy (IGRT), 60 Gy in 15 fractions in 3 weeks
- interventionNames
- Radiation: Radiation Therapy
- type
- ACTIVE_COMPARATOR
- label
- Conventional Radiation
- description
- Arm B: Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
- interventionNames
- Radiation: Conventional radiation
Primary outcomes (1)
- measure
- Overall Survival of Standard Radiation (CFRT) Versus Accelerated, Hypofractionated, Image-guided Conformal Radiotherapy (IGRT) in Treatment of Stage II-III NSCLC in Patients With Poor Performance Status at 1 Year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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 or III 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 within 6 months of study entry. * Patients must have the potential for benefit from local therapy (at the discretion of the investigator). * The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod performance status 0-1 and weight loss \>10% are considered eligible. In addition, patients determined to be medically unfit or refusing combined modality therapy are eligible. * Age ≥ 18. * 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 not have plans for concurrent chemoradiation therapy. * Patients must complete all required pretreatment evaluations Exclusion Criteria: * Total (aggregate) gross tumor volume \> 500 cm3 (500 cc's or 0.5 Liters) * Prior radiotherapy to the region of the study cancer that would result in direct 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.
References
Publications (1)
- DERIVEDIyengar P, Zhang-Velten E, Court L, Westover K, Yan Y, Lin MH, Xiong Z, Patel M, Rivera D, Chang J, Saunders M, Shivnani A, Lee A, Hughes R, Gerber D, Dowell J, Gao A, Heinzerling J, Li Y, Ahn C, Choy H, Timmerman R. Accelerated Hypofractionated Image-Guided vs Conventional Radiotherapy for Patients With Stage II/III Non-Small Cell Lung Cancer and Poor Performance Status: A Randomized Clinical Trial. JAMA Oncol. 2021 Oct 1;7(10):1497-1505. doi: 10.1001/jamaoncol.2021.3186. PMID 34383006