Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies

NCT01165658 | Terminated Phase 1

• 2 other identifiers: 2010-0164NCI-2012-01780
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.

Conditions

Non-small Cell Lung Cancer; Small Cell Lung Cancer; Carcinoid; Thymic Cancer; Lung Cancer

Keywords

non-small cell lung cancer; NSCLC; small cell lung cancer; SCLC; carcinoid; thymic cancer; lung cancer; radiation therapy; radiotherapy; proton therapy

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy

  Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.

  1 month after completion of radiation therapy

Study Arms (1)

Proton Therapy

EXPERIMENTAL

The radiation prescription dose ranges from 45 Gy in 3 Gy fractions to 60 Gy in 4 Gy fractions. Patients will be assigned to receive 1 of 3 doses of radiation therapy, based on when they joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.

Radiation: Proton Therapy

Interventions

Proton Therapy RADIATION

The regimen of 45 Gy in 15 fractions will be delivered as a baseline, and then the fraction size will be escalated in two different intervals of 0.5 Gy each, with the ultimate dose being 60 Gy in 4 Gy fractions.

Also known as: Radiation, XRT, Radiotherapy

Proton Therapy

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors
• Patients not receiving concurrent chemotherapy
• Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor \[EGFR\] or vascular endothelial growth factor \[VEGF\] inhibitors) will be eligible for the study.

You may not qualify if:

• Prior radiotherapy to the chest
• Life expectancy \<6 months
• Pregnancy

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Carcinoid Tumor; Thymus Neoplasms; Lung Neoplasms

Interventions

Proton Therapy; Radiation; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Therapeutics; Physical Phenomena

Study Officials

• Daniel Gomez, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2010
• First Posted: July 20, 2010
• Study Start: July 16, 2010
• Primary Completion: July 19, 2016
• Study Completion: July 19, 2016
• Last Updated: January 2, 2020

Record last verified: 2019-12

Locations

US (1)