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

• ClinicalTrials.gov Identifier: NCT01190527
• Recruitment Status: Completed
• First Posted: August 27, 2010
• Results First Posted: January 14, 2015
• Last Update Posted: June 2, 2017
• Sponsor: University of Michigan Rogel Cancer Center
• Information provided by (Responsible Party): University of Michigan Rogel Cancer Center

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.

Condition or disease	Intervention/treatment	Phase
Non-Small Cell Lung Cancer	Radiation: FDG-PET	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 42 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: August 2008
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: January 6, 2015

Arms and Interventions

Arm

Intervention/treatment

FDG-PET; All subjects will have the same course of treatment, the study treatment.

Radiation: FDG-PET; 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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 (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.

Contacts and Locations

Locations

United States, Michigan

University of Michigan Cancer Center

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Rogel Cancer Center

Investigators

• Principal Investigator: Shruti Jolly, M.D.; University of Michigan Rogel Cancer Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: University of Michigan Rogel Cancer Center
• ClinicalTrials.gov Identifier: NCT01190527
• Other Study ID Numbers: UMCC 2007.123
• First Posted: August 27, 2010
• Results First Posted: January 14, 2015
• Last Update Posted: June 2, 2017
• Last Verified: May 2017

Additional relevant MeSH terms:

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