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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

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ClinicalTrials.gov Identifier: NCT02607423
Recruitment Status : Withdrawn (The study failed to meet its accrual targets.)
First Posted : November 18, 2015
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

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.

Condition or disease Intervention/treatment Phase
Stage IIIA Non-Small Cell Lung Cancer Drug: Cisplatin Procedure: Computed Tomography Drug: Docetaxel Radiation: Fludeoxyglucose F-18 Drug: Gemcitabine Hydrochloride Drug: Pemetrexed Disodium Procedure: Positron Emission Tomography Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Early 18F-FDG-PET/CT Scan in Predicting Mediastinal Downstaging With Neoadjuvant Chemotherapy in Resectable Stage III A NSCLC
Estimated Study Start Date : November 19, 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Diagnostic (18F-FDG PET/CT)

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.

Drug: Cisplatin
Given IV
Other Names:
  • 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

Procedure: Computed Tomography
Undergo 18F-FDG PET/CT
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Drug: Docetaxel
Given IV
Other Names:
  • Docecad
  • RP56976
  • Taxotere
  • Taxotere Injection Concentrate

Radiation: Fludeoxyglucose F-18
Undergo 18F-FDG PET/CT
Other Names:
  • 18FDG
  • FDG
  • fludeoxyglucose F 18
  • Fludeoxyglucose F18
  • Fluorine-18 2-Fluoro-2-deoxy-D-Glucose
  • Fluorodeoxyglucose F18

Drug: Gemcitabine Hydrochloride
Given IV
Other Names:
  • dFdCyd
  • Difluorodeoxycytidine Hydrochloride
  • Gemzar
  • LY-188011

Drug: Pemetrexed Disodium
Given IV
Other Names:
  • 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

Procedure: Positron Emission Tomography
Undergo 18F-FDG PET/CT
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET SCAN
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • proton magnetic resonance spectroscopic imaging




Primary Outcome Measures :
  1. Rate of mediastinal downstaging [ Time Frame: Up to 9 weeks ]
    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 :
  1. Change of SUVmax [ Time Frame: Baseline to 3 weeks ]
    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.

  2. Overall survival [ Time Frame: Up to 5 years ]
    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.

  3. Percent change of metabolic tumor volume [ Time Frame: Baseline to 3 weeks ]
    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.

  4. Percent change of SUVpeak [ Time Frame: Baseline to 3 weeks ]
    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.

  5. Percent change of TLG [ Time Frame: Baseline to 3 weeks ]
    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.

  6. SUVmax [ Time Frame: At 3 weeks ]
    The predictive accuracy of SUVmax at T1 will be estimated by the ROC AUC with a 95% CI. The AUC will be estimated empirically.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607423


Locations
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United States, Pennsylvania
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Leora Horn ECOG-ACRIN Cancer Research Group
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Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT02607423    
Other Study ID Numbers: EA5123
NCI-2015-01054 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
EA5123 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
EA5123 ( Other Identifier: CTEP )
U10CA180820 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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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
Gemcitabine
Deoxyglucose
Cisplatin
Docetaxel
Pemetrexed
Fluorodeoxyglucose F18
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Folic Acid Antagonists