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NCT Number: NCT01190527

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FDG-PET

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.

Primary outcomes

  1. 2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT)

    Time frame: 2 years

    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 outcomes

  1. Number of Patients That Were Able to Receive Dose Escalation

    Time frame: 2 Years

    The number of patients for which dose escalation was possible will be reported.

  2. Percentage of Patients Alive at 2 Years

    Time frame: 2 years

    Overall survival of all patients will be estimated

  3. The Number of Participants That Experience Lung Toxicity and Esophagitis

    Time frame: 2 years

    The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study 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

Acronym: HUM15709

Important dates

Study start
2008
Primary completion
2014
Study completion
2015
First posted
Aug 27, 2010
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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