ACTIVE_NOT_RECRUITING

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

Conditions

Recurrent Lung Non-Small Cell Carcinoma Stage II Non-Small Cell Lung Cancer AJCC v7 Stage IIA Non-Small Cell Lung Carcinoma AJCC v7 Stage IIB Non-Small Cell Lung Carcinoma AJCC v7 Stage IIIA Non-Small Cell Lung Cancer AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2012-09-17

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT01629498

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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

Inclusion Criteria

Exclusion 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)

* 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

Contacts and Locations

Principal Investigator

Zhongxing Liao

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Zhongxing Liao, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2012-09-17

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2012-09-17

Study Completion Date2025-09-30

Terms related to this study

Additional Relevant MeSH Terms

Recurrent Lung Non-Small Cell Carcinoma
Stage II Non-Small Cell Lung Cancer AJCC v7
Stage IIA Non-Small Cell Lung Carcinoma AJCC v7
Stage IIB Non-Small Cell Lung Carcinoma AJCC v7
Stage IIIA Non-Small Cell Lung Cancer AJCC v7
Stage IIIB Lung Non-Small Cell Cancer AJCC v7