Trial record 20 of 3520 for:    Open Studies | radiotherapy

Stereotactic Body Radiotherapy (SBRT) Versus Stereotactic Body Proton Therapy (SBPT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01511081
First received: January 12, 2012
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

The goal of this clinical research study is to compare 2 types of radiotherapy, stereotactic body photon radiotherapy (SBRT) and stereotactic body proton radiotherapy (SBPT). Researchers would like to compare the side effects, quality of life, and cancer control.


Condition Intervention Phase
Non-small-cell Lung Cancer
Radiation: SBRT (stereotactic body radiotherapy)
Radiation: SBPT (stereotactic body proton therapy)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study Comparing Stereotactic Body Radiotherapy (SBRT) With Stereotactic Body Proton Therapy (SBPT) for Centrally Located Stage I, Selected Stage II and Recurrent Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Stereotactic Body Radiotherapy (SBRT) and Stereotactic Body Proton Therapy (SBPT Related Toxicities [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Outcome defined as 2-year rate of stereotactic body radiotherapy (SBRT)- and SBPT-related toxicities according to Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, including: radiation-induced pneumonitis/fibrosis/fistula, esophagitis/stricture/fistula.


Secondary Outcome Measures:
  • Treatment Response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Prospective assessment of positron emission tomography (PET) standardized uptake value (SUV) changes as a measure of treatment response and outcomes. Pulmonary function changes as a function of treatment and response.


Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBRT (stereotactic body radiotherapy)
50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
Radiation: SBRT (stereotactic body radiotherapy)
50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
Other Names:
  • Radiotherapy
  • XRT
Experimental: SBPT (stereotactic body proton therapy)
50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
Radiation: SBPT (stereotactic body proton therapy)
50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
Other Names:
  • Radiotherapy
  • XRT

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological confirmation (by biopsy or cytology) or clinically diagnosed primary non-small cell lung cancer (NSCLC). The following primary cancer types are eligible: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, bronchioloalveolar cell carcinoma, or non-small cell carcinoma not otherwise specified
  2. Centrally located, defined as located within 2 cm of the central bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), major vessels (aorta, pulmonary artery trunk, left/right pulmonary artery/vein main branches, superior/inferior vena cava, brachiocephalic artery trunk or left/right brachiocephalic vein, left/right subclavian artery/vein), esophagus, heart, tracheal, pericardium, mediastinal pleural and brachial plexus, chest wall and vertebral body, but no direct invasion, Stage I (T1-T2a <= 5 cm without main bronchus involvement), selective stage II ( selective T3 with involvement of mediastinal pleura, parietal pericardium,) based upon the following minimum diagnostic workup:
  3. continued from criteria #2) History/physical examination including weight and assessment of Zubrod performance status within 2 months prior to registration; Evaluation by an experienced thoracic cancer clinician within 2 months prior to registration; computed tomography (CT) scan with intravenous contrast (unless medically contraindicated) of the entirety of both lungs and the mediastinum, most part of liver, and adrenal glands acquired within 2 months prior to registration must be available. The primary tumor dimension will be measured on the CT in lung window. If PET/CT is performed within 2 month prior to registration, CT of chest is recommended but nor required. Whole body fluorodeoxyglucose positron emission tomography (FDG-PET) within 3 months prior to registration with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions and adrenal glands; Pulmonary function tests (PFTs):
  4. continued from inclusion #3) Routine spirometry, lung volumes, diffusion capacity (within 3 months prior to registration). Patients with hilar or mediastinal lymph nodes </= 1cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Patients with > 1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer. The primary tumor should be considered medically inoperable by an experienced thoracic cancer clinician for a standard lobectomy and mediastinal lymph node dissection/sampling procedure or patient refuses surgery. The patient may have underlying physiological medical problems that would prohibit a surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functioning lung.
  5. continued from inclusion #4) These types of patients with severe underlying health problems are deemed "medically inoperable." Standard justification for deeming a patient medically inoperable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline forced expiratory volume in 1 second (FEV1) < 50% predicted, postoperative FEV1 < 30% predicted, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia, exercise oxygen consumption < 50% predicted, severe pulmonary hypertension, diabetes mellitus with severe end organ damage, severe cerebral, cardiac, or peripheral vascular disease, or severe chronic heart disease. If the patient has medically resectable/operable disease but declines surgery after consulting with a thoracic surgeon, he/she will be considered eligible.
  6. History of NSCLC treated with surgery and/or radiotherapy previously and disease has been cured or clinically no disease progression for more than 6 months, now isolated recurrent disease in lung parenchyma and without involvement of main bronchus, chest wall, hilar/mediastinal lymph nodes and critical mediastinal structures. Biopsy of recurrent disease is recommended.
  7. Zubrod Performance Status 0-2;
  8. Age >/= 18
  9. Women of childbearing potential and male participants must agree to use a medically effective means of birth control, such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills, throughout their participation in the treatment phase of the study.
  10. The patient must provide study specific informed consent prior to study entry.

Exclusion Criteria:

  1. Direct evidence of hilar or mediastinal lymph nodes or distant metastases after appropriate staging studies.
  2. Patients with active pulmonary or pericardial infection.
  3. Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus.
  4. Patient pulmonary function showed that pre-bronchial dilator FEV1 <25% or DLCO<25%.
  5. Patient currently requiring supplemental oxygen for his/her daily life.
  6. Patient is pacemaker dependent.
  7. Patients </= 18 years of age.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511081

Contacts
Contact: Joe Y. Chang, MD, MS, PHD 713-563-2300

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Joe Y. Chang, MD, MS, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01511081     History of Changes
Other Study ID Numbers: 2011-0691, P01 CA021239, NCI-2012-00071
Study First Received: January 12, 2012
Last Updated: June 5, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Stereotactic Body Radiotherapy
Non-small-cell lung cancer
NSCLC
Centrally-located
Recurrent
Squamous cell carcinoma
Adenocarcinoma
Large cell carcinoma
Bronchioloalveolar cell carcinoma
Non-small cell carcinoma not otherwise specified
SBRT
Stereotactic Body Proton Therapy
SBPT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014