Phase 3
Completed N=103
Hypofractionated Image-Guided Radiation Therapy (IGRT) in Patients With Stage II-III Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer
Source: ClinicalTrials.gov NCT01459497 ↗
Enrolled (actual)
103
Serious AEs
0.0%
Results posted
May 2022
Primary outcomePrimary: 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. — 37.7; 44.6 percentage of participants
◆ Published Evidence
Established
94citations · ~19 / year
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.
Summary
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).
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
37.7; 44.6 | — |
| SECONDARY Toxicities of Two Radiotherapy Treatment Regimens in Patients With Stage II-III Non-Small Cell Lung Cancer (NSCLC) and Poor Performance Status |
144; 120 | — |
| SECONDARY Time to Local Progression of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status |
6.4; 7.3 | — |
| SECONDARY Disease-free Survival of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. |
4; 2 | — |
| SECONDARY Quality of Life of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. |
— | — |
| SECONDARY Cost Effectiveness of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. |
26,984; 33,723 | — |
| SECONDARY Quality Adjusted Life Survival Time of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. |
106; 83 | — |
| SECONDARY Quality Adjusted Life Survival Time of Two Radiotherapy Treatment Regimens in Patients With Stage II-III NSCLC and Poor Performance Status. |
106; 83 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01459497) and the linked publication. 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. Informational only — not medical advice.