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Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

Primary Purpose

Lung Cancer, Non Small Cell Lung Cancer, Solid Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation
Sponsored by
New Mexico Cancer Care Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring Lung cancer, radiation therapy, SBRT, Stereotactic Body Radiation Therapy, Tomotherapy, other solid tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs
  2. Medically inoperable stage I or II non small cell lung cancer with negative lymph nodes or metastatic cancer to lung with less than or equal to 3 lesions
  3. Age greater than or equal to 18 years old
  4. Zubrod performance status less than or equal to 1
  5. Negative pregnancy test for women of child bearing potential
  6. Informed consent
  7. Each lesion must be less than or equal to 5 cm in maximal diameter and multiple lesions must be less than or equal to 18 cm for the sum of the diameters in 3 dimensions. Example: 3 lesions each 2+2+2 cm have an aggregate diameter of 18 cm which is acceptable.
  8. No prior radiation to lesions being treated
  9. For metastatic disease to lung, primary tumor needs to be controlled (no evidence of progression on imaging for at least 2 months).

Exclusion Criteria:

  1. Contraindications to radiation
  2. Within or touching the zone of proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
  3. Pregnant or lactating females who chose to breast feed
  4. Patients must have recovered from toxicity of prior therapy
  5. Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications
  6. Cytologically positive pleural effusion

Sites / Locations

  • Universtiy of New Mexico Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stereotactic Body Radiation (SBRT)

Arm Description

60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days

Outcomes

Primary Outcome Measures

Response Rate (RR):
RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)

Secondary Outcome Measures

Treatment Related Toxicity
Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.
Overall Survival (OS)
The time from treatment initiation to death by any cause
Progression Free Survival (PFS)
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Clinical Benefit Rate (CBR)
CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).

Full Information

First Posted
January 29, 2009
Last Updated
May 18, 2021
Sponsor
New Mexico Cancer Care Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT00832780
Brief Title
Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Official Title
INST 0810: Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New Mexico Cancer Care Alliance

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the response of lung tumors to radiation therapy. This study will be using a type of radiation therapy called tomotherapy. Tomotherapy is a relatively new kind of therapy which is able to focus a large amount of radiation to a small area with relatively less radiation to the surrounding non-cancerous part of the organ. This study is being done to find out if this technique is able to control the cancer better or not than the standard radiation and also to study its safety.
Detailed Description
The introduction of stereotactic body radiation therapy (SBRT) has allowed safe dose escalation in treatment regimens for cancer. Several studies have shown a radiation dose-response relationship for survival and local control for tumors of the lung, including cancer that originates in the lung (such as non-small cell lung cancer) as well as cancer that metastasizes to the lung. The purpose of this study is to determine the response rate and toxicity of SBRT treatment of patients with lung tumors. This study will use a dose of 60 gray (Gy) in 5 fractions of 12 Gy. This provides a biological equivalent dose with alpha/beta ratio of 10 (BED10) of 132 Gy with the anticipation of achieving local control without increased toxicity. Previous studies have shown that the response rate with SBRT across multiple studies is approximately 50%, with an additional 25-40% of patients having stable disease. We hypothesize that this regimen will achieve a response rate of 70% with grade 3 toxicity of less than 5%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Non Small Cell Lung Cancer, Solid Tumors
Keywords
Lung cancer, radiation therapy, SBRT, Stereotactic Body Radiation Therapy, Tomotherapy, other solid tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stereotactic Body Radiation (SBRT)
Arm Type
Experimental
Arm Description
60 Gy using 12 Gy per fraction over 5 fractions, to be given within 10 calendar days
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation
Other Intervention Name(s)
SBRT
Intervention Description
A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the planning target volume. Dose homogeneity +/- 5%.
Primary Outcome Measure Information:
Title
Response Rate (RR):
Description
RR is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. RR is the sum of the percentage of patients who achieved a CR or PR. (RR = CR + PR)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Treatment Related Toxicity
Description
Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Frequency and severity of adverse events will be tabulated and reported.
Time Frame
2 years
Title
Overall Survival (OS)
Description
The time from treatment initiation to death by any cause
Time Frame
up to 67 months
Title
Progression Free Survival (PFS)
Description
The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame
2 years
Title
Clinical Benefit Rate (CBR)
Description
CBR is evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.0. Complete response (CR): Disappearance of all evidence of target and non-target lesions. Partial response (P): >= 30% reduction from baseline in the sum of the longest diameter of all lesions. Stable Disease (SD): Neither sufficient increase to qualify for PD nor sufficient shrinkage to qualify for PR. CBR is the sum of the percentage of patients who achieve a CR, PR or SD (CBR = CR + PR + SD).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic confirmation of non small cell lung cancer or other solid primary tumor metastatic to lungs Medically inoperable stage I or II non small cell lung cancer with negative lymph nodes or metastatic cancer to lung with less than or equal to 3 lesions Age greater than or equal to 18 years old Zubrod performance status less than or equal to 1 Negative pregnancy test for women of child bearing potential Informed consent Each lesion must be less than or equal to 5 cm in maximal diameter and multiple lesions must be less than or equal to 18 cm for the sum of the diameters in 3 dimensions. Example: 3 lesions each 2+2+2 cm have an aggregate diameter of 18 cm which is acceptable. No prior radiation to lesions being treated For metastatic disease to lung, primary tumor needs to be controlled (no evidence of progression on imaging for at least 2 months). Exclusion Criteria: Contraindications to radiation Within or touching the zone of proximal bronchial tree defined as a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi) Pregnant or lactating females who chose to breast feed Patients must have recovered from toxicity of prior therapy Any co morbid condition that' in the view of the attending physician' renders the patient at high risk from treatment complications Cytologically positive pleural effusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ben Liem, M.D
Organizational Affiliation
University of New Mexico Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtiy of New Mexico Comprehensive Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.nmcca.org
Description
New Mexico Cancer Care Alliance
URL
http://cancer.unm.edu
Description
University of New Mexico Cancer Center

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Phase II Study of Stereotactic Body Radiation Therapy Using Tomotherapy for Tumors of the Lung

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