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Fludeoxyglucose F-18 PET/CT in Predicting Response to Chemotherapy in Patients With Stage IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery

Primary Purpose

Stage IIIA Non-Small Cell Lung Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cisplatin
Computed Tomography
Docetaxel
Fludeoxyglucose F-18
Gemcitabine Hydrochloride
Pemetrexed Disodium
Positron Emission Tomography
Sponsored by
ECOG-ACRIN Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage IIIA Non-Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patient must have stage IIIA non-small cell lung cancer (T1-3N2) per American Joint Committee on Cancer (AJCC) 7th edition and must be considered to be surgically resectable
  • Patients must be assessed by surgeons and are considered surgically resectable
  • Mediastinal nodal metastases (N2) disease must be confirmed histologically
  • Easter Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Required imaging studies obtained within four weeks prior to registration
  • White blood cell (WBC) >= 4000 mm^3 or granulocyte count at least 2,000/mm^3
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 10.0g/dL
  • Total bilirubin < 1.5 mg/dL
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 3 x upper limit of normal (ULN)
  • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN
  • Alkaline phosphatase < 3 x ULN
  • Calculated/estimated or measured creatinine clearance at least 50 ml/min; note: creatinine clearance should be calculated using the Cockcroft-Gault formula; patients who will receive pemetrexed/cisplatin therapy must be obtained within 2 weeks of registration
  • Patients cannot have hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of registration; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is not considered cured is acceptable)
  • Patients must not have any history of other cancer within 5 years from registration with the exception of in situ carcinoma of the cervix, in situ carcinoma of the breast or completely resected non-melanoma skin cancer
  • Patients may not have received prior chemotherapy or radiation therapy for lung cancer
  • Patients with a history of myocardial infarction are eligible if the event occurred > 6 months prior to entry
  • Patients must not have any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, active angina, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements
  • Patents must have no contraindication to cisplatin chemotherapy including no clinically significant hearing loss unless willing to accept the potential of further loss of hearing, no symptomatic peripheral neuropathy
  • Women must not be pregnant or breast-feeding
  • All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy
  • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
  • Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
  • Patients must not have received any study therapies prior to registration

  • Pemetrexed/cisplatin therapy; note: patients who will receive pemetrexed/cisplatin therapy must meet all eligibility criteria below:

    • Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology
    • Calculated creatinine clearance must be obtained within 2 weeks of registration and calculated creatinine clearance (CrCl) must be >= 45mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl
  • Patients should have no contraindications for FDG-PET/CT

Sites / Locations

  • ECOG-ACRIN Cancer Research Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (18F-FDG PET/CT)

Arm Description

Patients undergo fludeoxyglucose F-18 PET/CT at baseline and after course 1 of chemotherapy. Patients undergo 1 of 3 chemotherapy regimens at the discretion of the investigator. CHEMOTHERAPY REGIMEN 1: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, and 8. Patients also receive cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY REGIMEN 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY REGIMEN 3: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Rate of mediastinal downstaging
The predictive accuracy of the percent change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal lymph nodes will be estimated by the area under a receiver operating characteristic (ROC) curve (AUC) with a 95% confidence interval (CI). The AUC will be estimated empirically. The reference standard for the ROC analysis will be the presence or absence of mediastinal downstaging, as assessed by thoracotomy, mediastinoscopy, mediastinotomy, endoscopic bronchoscopic ultrasound (EBUS), or endoscopic ultrasound (EUS).

Secondary Outcome Measures

Change of SUVmax
The predictive accuracy of the change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal lymph nodes will be estimated by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Overall survival
Time-dependent ROC analysis will be used to determine the predictive accuracy of percent change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal to predict overall survival.
Percent change of metabolic tumor volume
The predictive accuracy of percent change of metabolic tumor volume from T0 to T1 from primary tumor will be measured by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Percent change of SUVpeak
The predictive accuracy of percent change of SUVpeak from T0 to T1 from primary tumor will be measured by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Percent change of TLG
The predictive accuracy of percent change of TLG from T0 to T1 from primary tumor will be measured by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
SUVmax
The predictive accuracy of SUVmax at T1 will be estimated by the ROC AUC with a 95% CI. The AUC will be estimated empirically.

Full Information

First Posted
November 16, 2015
Last Updated
May 23, 2023
Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02607423
Brief Title
Fludeoxyglucose F-18 PET/CT in Predicting Response to Chemotherapy in Patients With Stage IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery
Official Title
Role of Early 18F-FDG-PET/CT Scan in Predicting Mediastinal Downstaging With Neoadjuvant Chemotherapy in Resectable Stage III A NSCLC
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study failed to meet its accrual targets.
Study Start Date
November 19, 2015 (Anticipated)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ECOG-ACRIN Cancer Research Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This phase II trial studies how well fludeoxyglucose F-18 (18F-FDG) positron emission tomography (PET)/computed tomography (CT) works in predicting response to chemotherapy in patients with stage IIIA non-small cell lung cancer that can be removed by surgery (resectable). Performing diagnostic procedures, such as fludeoxyglucose F-18 PET/CT, after one course of chemotherapy may help doctors predict a patient's response to treatment earlier and help plan the best treatment.
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate whether percent change in maximum standardized uptake value (SUVmax) on FDG-PET/CT from T0 to T1 measured on mediastinal lymph nodes can predict mediastinal downstaging in patients with stage IIIA-N2 non-small cell lung cancer (NSCLC) treated with neoadjuvant chemotherapy. SECONDARY OBJECTIVES: I. To evaluate the predictive accuracy for mediastinal downstaging of two other FDG-PET/CT-based markers measured on mediastinal lymph nodes: SUVmax at T1 and change of SUVmax from T0 to T1. II. To evaluate the predictive accuracy for mediastinal downstaging of the FDG-PET/CT-based markers measured on the primary tumor, include percent change of peak standardized uptake value (SUVpeak) (based on PET Response Criteria in Solid Tumors [PERCIST] criteria), total lesion glycolysis (TLG) and metabolic tumor volume (MTV) from T0 to T1. III. To evaluate whether percent change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal lymph nodes can predict overall survival (OS). OUTLINE: Patients undergo fludeoxyglucose F-18 PET/CT at baseline and after course 1 of chemotherapy. Patients undergo 1 of 3 chemotherapy regimens at the discretion of the investigator. CHEMOTHERAPY REGIMEN 1: Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1, and 8. Patients also receive cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY REGIMEN 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY REGIMEN 3: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (18F-FDG PET/CT)
Arm Type
Experimental
Arm Description
Patients undergo fludeoxyglucose F-18 PET/CT at baseline and after course 1 of chemotherapy. Patients undergo 1 of 3 chemotherapy regimens at the discretion of the investigator. CHEMOTHERAPY REGIMEN 1: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, and 8. Patients also receive cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY REGIMEN 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. CHEMOTHERAPY REGIMEN 3: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-diamminedichloroplatinum, Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol- AQ, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Intervention Description
Undergo 18F-FDG PET/CT
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Intervention Type
Radiation
Intervention Name(s)
Fludeoxyglucose F-18
Other Intervention Name(s)
18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Intervention Description
Undergo 18F-FDG PET/CT
Intervention Type
Drug
Intervention Name(s)
Gemcitabine Hydrochloride
Other Intervention Name(s)
dFdCyd, Difluorodeoxycytidine Hydrochloride, Gemzar, LY-188011
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Pemetrexed Disodium
Other Intervention Name(s)
Alimta, LY231514, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography
Other Intervention Name(s)
Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Intervention Description
Undergo 18F-FDG PET/CT
Primary Outcome Measure Information:
Title
Rate of mediastinal downstaging
Description
The predictive accuracy of the percent change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal lymph nodes will be estimated by the area under a receiver operating characteristic (ROC) curve (AUC) with a 95% confidence interval (CI). The AUC will be estimated empirically. The reference standard for the ROC analysis will be the presence or absence of mediastinal downstaging, as assessed by thoracotomy, mediastinoscopy, mediastinotomy, endoscopic bronchoscopic ultrasound (EBUS), or endoscopic ultrasound (EUS).
Time Frame
Up to 9 weeks
Secondary Outcome Measure Information:
Title
Change of SUVmax
Description
The predictive accuracy of the change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal lymph nodes will be estimated by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Time Frame
Baseline to 3 weeks
Title
Overall survival
Description
Time-dependent ROC analysis will be used to determine the predictive accuracy of percent change in SUVmax on FDG-PET/CT from T0 to T1 measured on mediastinal to predict overall survival.
Time Frame
Up to 5 years
Title
Percent change of metabolic tumor volume
Description
The predictive accuracy of percent change of metabolic tumor volume from T0 to T1 from primary tumor will be measured by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Time Frame
Baseline to 3 weeks
Title
Percent change of SUVpeak
Description
The predictive accuracy of percent change of SUVpeak from T0 to T1 from primary tumor will be measured by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Time Frame
Baseline to 3 weeks
Title
Percent change of TLG
Description
The predictive accuracy of percent change of TLG from T0 to T1 from primary tumor will be measured by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Time Frame
Baseline to 3 weeks
Title
SUVmax
Description
The predictive accuracy of SUVmax at T1 will be estimated by the ROC AUC with a 95% CI. The AUC will be estimated empirically.
Time Frame
At 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient must have stage IIIA non-small cell lung cancer (T1-3N2) per American Joint Committee on Cancer (AJCC) 7th edition and must be considered to be surgically resectable Patients must be assessed by surgeons and are considered surgically resectable Mediastinal nodal metastases (N2) disease must be confirmed histologically Easter Cooperative Oncology Group (ECOG) performance status 0 or 1 Required imaging studies obtained within four weeks prior to registration White blood cell (WBC) >= 4000 mm^3 or granulocyte count at least 2,000/mm^3 Platelets >= 100,000/mm^3 Hemoglobin >= 10.0g/dL Total bilirubin < 1.5 mg/dL Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 3 x upper limit of normal (ULN) Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 3 x ULN Alkaline phosphatase < 3 x ULN Calculated/estimated or measured creatinine clearance at least 50 ml/min; note: creatinine clearance should be calculated using the Cockcroft-Gault formula; patients who will receive pemetrexed/cisplatin therapy must be obtained within 2 weeks of registration Patients cannot have hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years of registration; (prior surgery, biologic therapy, hormonal therapy, or radiation therapy for a malignancy over 5 years prior to enrollment that is not considered cured is acceptable) Patients must not have any history of other cancer within 5 years from registration with the exception of in situ carcinoma of the cervix, in situ carcinoma of the breast or completely resected non-melanoma skin cancer Patients may not have received prior chemotherapy or radiation therapy for lung cancer Patients with a history of myocardial infarction are eligible if the event occurred > 6 months prior to entry Patients must not have any clinically significant ongoing, active or serious infection, symptomatic or uncontrolled congestive heart failure, active angina, symptomatic or uncontrolled cardiac arrhythmia or any other medical condition or psychiatric illness/social situations that would limit compliance with study requirements Patents must have no contraindication to cisplatin chemotherapy including no clinically significant hearing loss unless willing to accept the potential of further loss of hearing, no symptomatic peripheral neuropathy Women must not be pregnant or breast-feeding All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study Patients must not have received any study therapies prior to registration Pemetrexed/cisplatin therapy; note: patients who will receive pemetrexed/cisplatin therapy must meet all eligibility criteria below: Patients assigned to pemetrexed/cisplatin therapy must NOT have squamous cell histology Calculated creatinine clearance must be obtained within 2 weeks of registration and calculated creatinine clearance (CrCl) must be >= 45mL/min using the standard Cockcroft and Gault formula, or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate CrCl Patients should have no contraindications for FDG-PET/CT
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leora Horn
Organizational Affiliation
ECOG-ACRIN Cancer Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
ECOG-ACRIN Cancer Research Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Fludeoxyglucose F-18 PET/CT in Predicting Response to Chemotherapy in Patients With Stage IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery

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