Non-Small Cell Lung Cancer
Conditions
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.
Interventions
RADIATIONFDG-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.
Sponsors
University of Michigan Rogel Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT) | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients Alive at 2 Years | 2 years | Overall survival of all patients will be estimated |
| Number of Patients That Were Able to Receive Dose Escalation | 2 Years | The number of patients for which dose escalation was possible will be reported. |
| The Number of Participants That Experience Lung Toxicity and Esophagitis | 2 years | The number of participants that experience RT (radiation therapy) induced lung toxicity, and grade 2 or greater (symptomatic) esophagitis, will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adaptive Radiation Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | Adaptive Radiation |
|---|---|
| Age, Continuous | 63 years |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 42 |
| serious Total, serious adverse events | 29 / 42 |
Outcome results
Primary
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.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adaptive Radiation | 2 Year Rate of Overall Local-Regional Tumor Control Using FGD-PET-CT During Radiation Therapy(RT) | 68 percentage of patients |
Secondary
Number of Patients That Were Able to Receive Dose Escalation
The number of patients for which dose escalation was possible will be reported.
Time frame: 2 Years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adaptive Radiation | Number of Patients That Were Able to Receive Dose Escalation | 42 participants |
Secondary
Percentage of Patients Alive at 2 Years
Overall survival of all patients will be estimated
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adaptive Radiation | Percentage of Patients Alive at 2 Years | 51 percentage of patients |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adaptive Radiation | The Number of Participants That Experience Lung Toxicity and Esophagitis | RT-induced lung toxicity | 8 participants |
| Adaptive Radiation | The Number of Participants That Experience Lung Toxicity and Esophagitis | esophagitis (grade 2 or greater) | 13 participants |