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Could PET scans guide radiation to better fight lung cancer?

NCT ID NCT01507428

Disease control Sponsor: National Cancer Institute (NCI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using PET/CT scans during treatment to adjust radiation plans can improve outcomes for people with stage III non-small cell lung cancer. 138 participants were randomly assigned to receive either standard radiation or radiation guided by mid-treatment scans. The goal was to see if the adaptive approach could better control the tumor locally without increasing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy guided by PET/CT scans
What this could lead to
If successful, this approach could allow doctors to deliver higher, more effective radiation doses to tumors while sparing healthy tissue, potentially improving local control of lung cancer.
What could go wrong
This is a mid-stage trial with only 138 participants, so results may not apply to all patients. The benefit over standard radiation is unproven, and there are risks from radiation exposure and chemotherapy side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

138 people

The number who actually took part.

Started

Feb 2012

Finished

May 2022

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must have FDG-avid (maximum SUV \>= 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven non-small cell lung cancer * Patients must be clinical American Joint Committee on Cancer (AJCC) stage IIIA or IIIB (AJCC, 7th ed.) with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team, involving evaluation by at least 1 thoracic surgeon within 8 weeks prior to registration; Note: For patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and a medical oncologist, or pulmonologist * Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned * History/physical examination, including documentation of weight, within 2 weeks prior to registration * FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration * CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration * CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration * Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) \>= 1.2 Liter or \>= 50% predicted without bronchodilator * Zubrod performance status 0-1 * Able to tolerate PET/CT imaging required to be performed at an American College of Radiology (ACR) Imaging Core Laboratory (Lab) qualified facility * Absolute neutrophil count (ANC) \>= 1,500 cells/mm\^3 (within 2 weeks prior to registration on study) * Platelets \>= 100,000 cells/mm\^3 (within 2 weeks prior to registration on study) * Hemoglobin (Hgb) \>= 10.0 g/dL (note: the use of transfusion or other intervention to achieve Hgb \>= 10.0 g/dL is acceptable) (within 2 weeks prior to registration on study) * Serum creatinine within normal institutional limits or a creatinine clearance \>= 60 ml/min within 2 weeks prior to registration * Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential * Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study * The patient must provide study-specific informed consent prior to study entry Exclusion Criteria: * Patients with any component of small cell lung carcinoma are excluded * Patients with evidence of a malignant pleural or pericardial effusion are excluded * Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible) * Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Severe, active co-morbidity, defined as follows: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months * Transmural myocardial infarction within the last 6 months * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol * Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception * Poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications; patients with diabetes will preferably be scheduled in the morning and instructions for fasting and use of medications will be provided in consultation with the patients' primary physicians * Patients with T4 disease with radiographic evidence of massive invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stage III lung non-small cell cancer ajcc V7 Stage IIIA lung non-small cell cancer ajcc V7 Stage IIIB lung non-small cell cancer ajcc V7

Contacts and locations

Locations

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Case Western Reserve University

    Cleveland, Ohio, 44106, United States

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131, United States

  • Cleveland Clinic Cancer Center Strongsville

    Strongsville, Ohio, 44136, United States

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Cleveland Clinic Wooster Family Health and Surgery Center

    Wooster, Ohio, 44691, United States

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124, United States

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • McGill University Department of Oncology

    Montreal, Quebec, H2W 1S6, Canada

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Sleepy Hollow

    Sleepy Hollow, New York, 10591, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Reading Hospital

    West Reading, Pennsylvania, 19611, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111, United States

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, 94304, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109, United States

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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