NCT01629498Active, not recruitingPhase 1/2

Image-Guided, Intensity-Modulated Photon or Proton Beam Radiation Therapy in Treating Patients With Stage II-IIIB Non-small Cell Lung Cancer

Phase I/II Trial of Image-Guided, Intensity-Modulated Photon (IMRT) or Scanning Beam Proton Therapy (IMPT) Both With Simultaneous Integrated Boost (SIB) Dose Escalation to the Gross Tumor Volume (GTV) With Concurrent Chemotherapy for Stage II/III Non-Small Cell Lung Cancer (NSCLC)

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

This partially randomized phase I/II trial studies the side effects and best dose of image-guided, intensity-modulated photon or proton beam radiation therapy and to see how well they work in treating patients with stage II-IIIB non-small cell lung cancer. This trial is testing a new way of delivering radiation dose when only the tumor receives dose escalation while the surrounding normal structure is kept at standard level. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator (linac). The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Proton beam radiation therapy is a type of radiation therapy that uses streams of protons (tiny particles with a positive charge) to kill tumor cells. Both methods are designed to give a higher than standard dose of treatment to the tumor and may reduce the amount of radiation damage to healthy tissue near a tumor.

Status (registry): Active, not recruiting
Phase (registry): Phase 1/2
Study type: Interventional
Enrollment: 146 (actual)
First submitted: 25 Jun 2012
Start date: Sept 2012
Primary completion date: Sept 2027
Lead sponsor: M.D. Anderson Cancer Center
Diseases: Lung cancer
NCT number: NCT01629498

What you commit to

Study type: Interventional · Phase 1/2
Participants enrolled: 146
From Sept 2012 to the primary completion date, Sept 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Prior radiotherapy to any anatomic regions that would result in overlap of radiation dose distribution to critical structures (esophagus, heart, spinal cord, brachial plexus)

Other illness

T4 tumor with direct invasion of esophagus, spinal cord, major blood vessel, or heart

Other

Pregnancy
Patients of childbearing potential must practice appropriate contraception
Patient refusal

Who the study is looking for

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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
M D Anderson Cancer Center Coordinator of this site? Confirm its status	Houston	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.