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Lung CancerPhase 2NCT00083083

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

A Phase 2 study testing carboplatin, cisplatin and docetaxel in people with Lung Cancer, run by American College of Radiology Imaging Network at 49 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
carboplatin, cisplatin and docetaxel
Type of treatment
Surgery or procedure
How many people
250 participants
Where
49 sitesin 3 countries
Study dates
Mar 2005to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC)
  • Clinical stage IIB or III disease
  • No small cell carcinoma
  • No stage IV disease*
  • No diffuse bronchoalveolar subtype
  • No planned definitive surgical resection NOTE: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation
  • Planning treatment with definitive chemoradiotherapy
  • May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
  • Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy
  • No brain metastases by head CT scan or MRI

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
  • Able to tolerate positron emission tomography imaging
  • No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL)
  • No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy

Chemotherapy

  • See Disease Characteristics
  • No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • See Disease Characteristics
  • No prior thoracic radiotherapy
  • No concurrent intensity-modulated radiotherapy

Surgery

  • See Disease Characteristics

Trial locations and contacts

49 sites in 3 countries.

49 sites in 3 countries

United States46 sites

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44302

  • Saint John's Cancer Center at Saint John's Medical Center

    Anderson, Indiana, 46016

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

    Birmingham, Alabama, 35294

  • Dana-Farber Partners Cancer Care

    Boston, Massachusetts, 02129

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital

    Boynton Beach, Florida, 33435

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Rush Cancer Institute at Rush University Medical Center

    Chicago, Illinois, 60612

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390

  • North Broward Medical Center

    Dearfield Beach, Florida, 33064-3596

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, 77030-4009

  • Integrated Community Oncology Network at Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232-6838

  • Hospital of Saint Raphael

    New Haven, Connecticut, 06511

  • Oklahoma University Cancer Institute

    Oklahoma City, Oklahoma, 73104

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center - Philadelphia

    Philadelphia, Pennsylvania, 19111-2497

  • Albert Einstein Cancer Center

    Philadelphia, Pennsylvania, 19141

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15232

  • Knight Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908-4735

  • Brown University School of Medicine

    Providence, Rhode Island, 02912

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Bon Secours Cancer Institute at St. Mary's Hospital

    Richmond, Virginia, 23226

  • William Beaumont Hospital - Royal Oak Campus

    Royal Oak, Michigan, 48073

  • Radiological Associates of Sacramento Medical Group at Sutter Cancer Center

    Sacramento, California, 95816

  • Huntsman Cancer Institute at University of Utah

    Salt Lake City, Utah, 84112

  • Scottsdale Medical Imaging, Limited

    Scottsdale, Arizona, 85262

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • South Shore Hospital

    South Weymouth, Massachusetts, 02190

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Mallinckrodt Institute of Radiology at Washington University Medical Center

    St Louis, Missouri, 63110

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital

    Teaneck, New Jersey, 07666

  • J. Phillip Citta Regional Cancer Center at Community Medical Center

    Toms River, New Jersey, 08755

  • Waukesha Memorial Hospital Regional Cancer Center

    Waukesha, Wisconsin, 53188

  • Lankenau Cancer Center at Lankenau Hospital

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Canada2 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Grand River Regional Cancer Centre at Grand River Hospital

    Kitchner, Ontario, N2G 1G3

Other trials in Canada

South Korea1 site

  • National Cancer Center - Korea

    Goyang, 410-769

Other trials in South Korea

About this study

Official title: Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.

PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.

Secondary

  • Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
  • Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
  • Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
  • Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

OUTLINE: This is a diagnostic, multicenter study.

Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging.

Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.

PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

Conditions
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Secondary outcomes (8)

  1. Relationship of survival to post-treatment max SUV as determined by the imaging institute

  2. Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution

  3. Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution

  4. Reliability between peak and max SUV measurements both pre- and post-treatment

  5. Proportion of participants who are either upstaged or downstaged by positron emission tomography scan

  6. Reliability between PET scan-defined response to therapy measurements

  7. Correlation of Ki-67 expression with peak and max pre-treatment SUV

  8. Association between Ki-67 expression and overall survival at 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2004 (estimated)
  2. Study startMar 2005
  3. Primary completionJun 2006 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083083
Sponsor's protocol ID
CDR0000362061
Other IDs
ACRIN-6668, RTOG-0235
Status last verified
Oct 2007
First submitted
14 May 2004
Last updated
1 Mar 2011
Results posted
No

Publications

  • Zhang J, Hu Y, Tian C, Zhang X, Bian Y. Development of a Prognostic Predictive Model for Stage III Non-Small Cell Lung Cancer using PET-CT Radiomics Based on Multi-Center and Heterogeneous Data and External Validation. Pak J Med Sci. 2026 May;42(5):1214-1221. doi: 10.12669/pjms.42.5.14183.

    PubMed 42291584

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carboplatin, cisplatin and docetaxel in people with Lung Cancer, run by American College of Radiology Imaging Network at 49 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083083, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2011.

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