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Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer (HUM15709)

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FDG-PET
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If pathology not definitive, the patient needs to have a clinically diagnosed non-small cell lung cancer, which is also FDG-avid.
  • Patients must be 18 years of age or older.
  • Patients must have Karnofsky performance score > 60.
  • Patients must have clinical AJCC (American Joint Committee on Cancer) Stage I-IIIB, with unresectable or inoperable disease.
  • Patients must have no evidence of a malignant pleural or pericardial effusion
  • Patients must have hemoglobin > 10 gm/dl. Transfusions or medications may be used to achieve this criterion.

  • Patients must have reasonable organ and marrow functions as defined below if chemotherapy is considered:

    • WBC (White Blood Cell) > 3,000/mm3.
    • absolute neutrophil count ≥ 1,500/mm3.
    • platelets > 100,000/mm3
    • total bilirubin ≤ 3.0 mg/dl.
    • AST ( Aspartate Aminotransferase or SGOT) and ALT (Alanine Transaminase or SGPT) < 4 X institutional upper limit of normal.
    • creatinine ≤ 2.0 mg/dl.
  • Patients must not have serious intercurrent diseases per the judgment of the treating physician.
  • Patient must be willing to use effective contraception if female with reproductive capability.
  • Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

  • Patients with any component of small cell lung carcinoma are excluded from this study.
  • Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.
  • Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
  • Prisoners are excluded for this study.

Sites / Locations

  • University of Michigan Cancer Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FDG-PET

Arm Description

All subjects will have the same course of treatment, the study treatment.

Outcomes

Primary Outcome Measures

2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.

Secondary Outcome Measures

Number of Patients That Were Able to Receive Dose Escalation
The number of patients for which dose escalation was possible will be reported.
Percentage of Patients Alive at 2 Years
Overall survival of all patients will be estimated
The Number of Participants That Experience Lung Toxicity and Esophagitis
The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.

Full Information

First Posted
April 1, 2010
Last Updated
May 3, 2017
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01190527
Brief Title
Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer
Acronym
HUM15709
Official Title
Using FDG-PET Acquired During the Course of Radiation Therapy to Individualize Adaptive Radiation Dose Escalation in Patients With Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
January 6, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body, and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment, and then again during treatment to see if the procedure helps predict how well the treatment works for your cancer and how well your lung functions during treatment. FDG-PET is a modern technology that uses small amounts of a radioactive glucose (FDG) to make images of your whole body and areas of active cancer. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located. The study will help the investigator determine whether an adaptive plan that is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), can show if there is an improvement in treatment outcome compared to those treated with standard radiation therapy. This adaptive plan may allow your doctor to escalate the dose per treatment and the total dose of your treatment based on the risk of damage to your healthy lung tissue. While increasing the radiation dose, but limiting the toxicity to normal lung tissue, the researchers hope to improve your tumor control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
FDG-PET
Arm Type
Other
Arm Description
All subjects will have the same course of treatment, the study treatment.
Intervention Type
Radiation
Intervention Name(s)
FDG-PET
Intervention Description
This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment and again during treatment to see if it helps predict how well the treatment works for the cancer. The standard of care for patients with stage III unresectable NSCLC is combined chemoradiotherapy. This study will seek to determine 2 year local-regional progression free survival in patients with non-small cell lung cancer (NSCLC) when an adaptive plan is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), and investigate if there is an improvement compared to those treated with conventional radiation therapy without field and/or dose modification. The investigators hypothesize that during-RT, PET-CT-based adaptive therapy will allow them to dose escalate in the majority of patients and meet the dose limits of normal structures, thus improving local tumor control without increasing toxicity.
Primary Outcome Measure Information:
Title
2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)
Description
Use FGD-PET-CT based adaptive radiation to deliver a higher total dose to the active tumor to determine if it will improve the local-regional tumor control and progression-free survival in patients, without increasing the normal tissue complication probability (NTCP) of the lung.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Patients That Were Able to Receive Dose Escalation
Description
The number of patients for which dose escalation was possible will be reported.
Time Frame
2 Years
Title
Percentage of Patients Alive at 2 Years
Description
Overall survival of all patients will be estimated
Time Frame
2 years
Title
The Number of Participants That Experience Lung Toxicity and Esophagitis
Description
The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients must have FDG-avid and pathologically proven non-small cell lung cancer. If pathology not definitive, the patient needs to have a clinically diagnosed non-small cell lung cancer, which is also FDG-avid. Patients must be 18 years of age or older. Patients must have Karnofsky performance score > 60. Patients must have clinical AJCC (American Joint Committee on Cancer) Stage I-IIIB, with unresectable or inoperable disease. Patients must have no evidence of a malignant pleural or pericardial effusion Patients must have hemoglobin > 10 gm/dl. Transfusions or medications may be used to achieve this criterion. Patients must have reasonable organ and marrow functions as defined below if chemotherapy is considered: WBC (White Blood Cell) > 3,000/mm3. absolute neutrophil count ≥ 1,500/mm3. platelets > 100,000/mm3 total bilirubin ≤ 3.0 mg/dl. AST ( Aspartate Aminotransferase or SGOT) and ALT (Alanine Transaminase or SGPT) < 4 X institutional upper limit of normal. creatinine ≤ 2.0 mg/dl. Patients must not have serious intercurrent diseases per the judgment of the treating physician. Patient must be willing to use effective contraception if female with reproductive capability. Patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: Patients with any component of small cell lung carcinoma are excluded from this study. Prior radiotherapy to the thorax such that composite radiation would significantly overdose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints. Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. Prisoners are excluded for this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shruti Jolly, M.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28570742
Citation
Kong FM, Ten Haken RK, Schipper M, Frey KA, Hayman J, Gross M, Ramnath N, Hassan KA, Matuszak M, Ritter T, Bi N, Wang W, Orringer M, Cease KB, Lawrence TS, Kalemkerian GP. Effect of Midtreatment PET/CT-Adapted Radiation Therapy With Concurrent Chemotherapy in Patients With Locally Advanced Non-Small-Cell Lung Cancer: A Phase 2 Clinical Trial. JAMA Oncol. 2017 Oct 1;3(10):1358-1365. doi: 10.1001/jamaoncol.2017.0982.
Results Reference
derived

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Using FDG-PET During Radiation Therapy in Non-Small Cell Lung Cancer

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