Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01190527
First received: April 1, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Non-Small Cell Lung Cancer
 Radiation: Adaptive radiation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • Using FGD-PET-CT During Radiation Therapy(RT) [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    During-RT, using PET-CT based adaptive radiation to deliver a higher total dose to the active tumor, 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:
  • Dose Escalation [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    Total biological equivalent dosing difference between the 6-week prescribed plan using pre-RT imaging, will be compared to the dose delivered using the adaptive planning technique. At a minimum, the number of patients for which dose escalation was possible will be reported, along with the mean and standard deviation in the dose increase for the population.

  • Correlation Between Pre-Radiation Therapy Tumor Sizes [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    Correlations between pre-radiation therapy tumor sizes, distance from important anatomical structures and the dose increase, may be explored using the rank method of Spearman. Overall survival of all patients will be estimated using the product-limit method of Kaplan and Meier.

  • Toxicities [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]
    Toxicities will be reported as proportions with exact binomial confidences intervals. Standard unconditional logistic regression techniques will be used to explore potential associations between the levels of transforming growth factor beta one, and other molecules the occurrence of treatment-related toxicity. The relationship will be explored by dichotomizing toxicity events by meaningful grade and/or by the type of toxicity (e.g. pneumonitis vs. fibrosis.


Estimated Enrollment: 42
Study Start Date: August 2008
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
single arm
All subjects will have the same course of treatment, the study treatment
 Radiation: Adaptive radiation
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 > 3,000/mm3.
    • absolute neutrophil count ≥ 1,500/mm3.
    • platelets > 100,000/mm3
    • total bilirubin ≤ 3.0 mg/dl.
    • AST (SGOT) and ALT (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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190527

Locations
United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Feng-Ming Kong, MD, Ph.D University of Michigan Cancer Center
  More Information

No publications provided

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01190527     History of Changes
Other Study ID Numbers: UMCC 2007.123
Study First Received: April 1, 2010
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board

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 June 17, 2013