Lung cancer radiation gets a precision boost: trial aims to hit tumors harder, spare healthy tissue
NCT ID NCT01629498
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study tests whether giving a higher radiation dose directly to the tumor, while keeping the standard dose to surrounding healthy tissue, can improve outcomes for people with stage II to IIIB non-small cell lung cancer. About 146 participants will receive either photon (IMRT) or proton (IMPT) radiation therapy along with chemotherapy. The goal is to find the safest highest dose and see if it helps control the tumor longer without causing severe side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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146 people
The number who actually took part.
- Started
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Sep 2012
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologically proven diagnosis of unresected stage II-IIIB, or recurrent after surgical resection or stereotactic body radiation therapy (SBRT) non-small cell lung cancer * Suitability for concurrent chemoradiation therapy per treating physician's assessment * Karnofsky performance status (KPS) score \>= 70 * Weight loss \< 15% in the 3 months before diagnosis * Prior receipt of induction chemotherapy followed by referral for concurrent chemoradiation is allowed * Adequate lung function indicated by forced expiratory volume at 1 second (FEV1) \>= 1 L is required * The primary tumor and/or regional lymph nodes must be evaluable radiographically * The gross target volume (GTV) is suitable for motion management using 4 dimensional computed tomography (4D CT), internal target volume (ITV), or respiratory gating; in addition, the target coverage and normal tissue constraints must be met as specified in protocol accounting for the respiratory motion of anatomy as a whole (not just the tumor) * No prior radiation to the mediastinal structures * Hemoglobin \>= 9.0 g/dL * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Total bilirubin =\< 1.5 times the upper limit of normal (ULN) * Alanine and aspartate transaminases (ALT and AST) =\< 2.5 times the ULN (=\< 5 x ULN for patients with liver involvement) * Creatinine =\< 1.5 times ULN * Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of MD Anderson Cancer Center (MDACC) Exclusion Criteria: * Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus) * T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart * Pregnancy * Patients of childbearing potential must practice appropriate contraception * Patient refusal
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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