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

NCT01629498 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: 2011-1058NCI-2012-01224P01CA021239U19CA021239
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (4)

• Maximum tolerated dose (MTD) for intensity-modulated photon therapy (IMRT) (Phase I)

  Will be defined as the highest simultaneous integrated boost volume (SIBV) dose that has posterior probability of dose-limiting toxicity (DLT) =\< 30%. DLT are defined as Common Terminology Criteria for Adverse Events (CTCAE) 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.

  90 days

• MTD for intensity-modulated proton therapy (IMPT) (Phase I)

  Will be defined as the highest SIBV dose that has posterior probability of DLT =\< 30%. DLT are defined as CTCAE 4.0 grade 3+ acute radiation toxicity, including esophagitis, pneumonitis, and skin reaction that are definitely, or probably related to radiation treatment. Toxicities will be tabulated by dose, severity, and relationship to radiation therapy.

  90 days

• Survival free of grade >= 3 toxicity (with a target of at least 75%) (Phase II)

  6 months

• Local progression-free survival (75% at 6 months) d (Phase II)

  Will be defined as tumor recurrence or progression inside or at the boundary of the volume defined by the 60 Gy (relative biological effectiveness) isodose line. A Bayesian method will be applied.

  6 months

Secondary Outcomes (7)

• Time to local failure (Phase II)

  Up to 5 years

• Progression-free survival (Phase II)

  Up to 5 years

• Overall survival (Phase II)

  Up to 5 years

• Posterior probability that the DLT rate 90 days from day 1 of radiation therapy is more than 30% (Phase II)

  90 days

• Changes in selected biomarkers (Phase II)

  Baseline to up to 5 years

Study Arms (2)

Arm I (image-guided IMRT)

EXPERIMENTAL

Patients undergo image-guided IMRT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Photon Beam Radiation Therapy; Other: Questionnaire Administration

Arm II (image-guided IMPT)

EXPERIMENTAL

Patients undergo image-guided IMPT SIB QD 5 days a week for up to 6 weeks in the absence of disease progression or unacceptable toxicity.

Radiation: Image Guided Radiation Therapy; Radiation: Intensity-Modulated Radiation Therapy; Other: Laboratory Biomarker Analysis; Radiation: Proton Beam Radiation Therapy; Other: Questionnaire Administration

Interventions

Intensity-Modulated Radiation Therapy RADIATION

Undergo image-guided IMRT

Also known as: IMRT, Intensity Modulated RT, Intensity-Modulated Radiotherapy

Arm I (image-guided IMRT)

Laboratory Biomarker Analysis OTHER

Optional correlative studies

Arm I (image-guided IMRT); Arm II (image-guided IMPT)

Photon Beam Radiation Therapy RADIATION

Undergo image-guided IMRT

Arm I (image-guided IMRT)

Proton Beam Radiation Therapy RADIATION

Undergo image-guided IMPT

Also known as: PBRT, Proton Radiation Therapy

Arm II (image-guided IMPT)

Questionnaire Administration OTHER

Ancillary studies

Arm I (image-guided IMRT); Arm II (image-guided IMPT)

Image Guided Radiation Therapy RADIATION

Undergo image-guided IMRT

Also known as: IGRT, image-guided radiation therapy

Arm I (image-guided IMRT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiotherapy, Image-Guided; Radiotherapy, Intensity-Modulated; Proton Therapy; Protons

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Heavy Ion Radiotherapy; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Zhongxing Liao

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 27, 2012
• Study Start: September 17, 2012
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)