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Lung CancerPhase 2NCT01055197

Radiation Therapy in Treating Patients With Extensive Stage Small Cell Lung Cancer

A Phase 2 study testing Prophylactic Cranial Irradiation and Radiation Therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 115 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer. PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the… 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?
Prophylactic Cranial Irradiation and Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
115 sitesin 3 countries
Study dates
Mar 2010to Dec 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 or cytologically confirmed extensive stage small cell lung cancer (SCLC) diagnosed within the past 6 months*
  • Has 1-4 extracranial metastatic lesions NOTE: *Diagnosis made before treatment with chemotherapy
  • Has completed 4-6 courses of platinum-based chemotherapy within the past 8 weeks AND meets the following criteria:
  • Radiographic partial or complete response to chemotherapy in ≥ 1 site of disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria (if radiotherapy has been delivered to primary disease with chemotherapy, there must be complete or partial response in ≥ 1 of the sites that has not been treated with radiotherapy)
  • No progression in any site
  • No limited stage SCLC, even if disease progressed
  • No brain or central nervous system (CNS) metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,000/mm^3
  • Platelets ≥ 75,000/mm^3
  • Hemoglobin ≥ 8.0 g/dL (the use of transfusion or other intervention is allowed)
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN) (for patients who will receive radiotherapy to the liver)
  • Serum bilirubin < 1.5 times ULN (for patients who will receive radiotherapy to the liver)
  • Serum creatinine < 1.5 times ULN (for patients who will receive radiotherapy to the kidneys)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No severe, active co-morbidity, defined as any of the following:
  • Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of study registration

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from prior chemotherapy (i.e., toxicities ≤ grade 1 [except for neuropathy and alopecia])
  • Thoracic radiotherapy administered concurrently with or before chemotherapy for the current diagnosis allowed (these patients will not receive mediastinal radiotherapy per protocol)
  • No prior radiotherapy to the region of this cancer that would result in overlap of radiotherapy fields
  • No concurrent chemotherapy

Trial locations and contacts

115 sites in 3 countries.

115 sites in 3 countries

United States108 sites

  • Hickman Cancer Center at Bixby Medical Center

    Adrian, Michigan, 49221

  • McDowell Cancer Center at Akron General Medical Center

    Akron, Ohio, 44307

  • Summa Center for Cancer Care at Akron City Hospital

    Akron, Ohio, 44309-2090

  • New York Oncology Hematology, PC at Albany Regional Cancer Care

    Albany, New York, 12206

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87131-5636

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

    Anderson, Indiana, 46016

  • Texas Oncology, PA at Texas Cancer Center - Arlington South

    Arlington, Texas, 76014

  • Georgia Cancer Center for Excellence at Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory Crawford Long Hospital

    Atlanta, Georgia, 30308

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322

  • St. Agnes Hospital Cancer Center

    Baltimore, Maryland, 21229

  • Barberton Citizens Hospital

    Barberton, Ohio, 44203

  • Boston University Cancer Research Center

    Boston, Massachusetts, 02118

  • Cancer Institute of Cape Girardeau, LLC

    Cape Girardeau, Missouri, 63703

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

    Chicago, Illinois, 60611-3013

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Cancer Center at Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital

    Clinton Township, Michigan, 48038

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210-1240

  • Texas Oncology, PA at Texas Cancer Center - Denton South

    Denton, Texas, 76210

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Poudre Valley Radiation Oncology

    Fort Collins, Colorado, 80528

  • Radiation Oncology Associates Southwest

    Fort Wayne, Indiana, 46804

  • Parkview Regional Cancer Center at Parkview Health

    Fort Wayne, Indiana, 46805

  • Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

    Fort Worth, Texas, 76104

  • Saint Agnes Cancer Center at Saint Agnes Medical Center

    Fresno, California, 93720

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Center for Cancer Care at Goshen General Hospital

    Goshen, Indiana, 46526

  • Butterworth Hospital at Spectrum Health

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Three Rivers Community Hospital

    Grants Pass, Oregon, 97527

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • Memorial Hermann Hospital - Memorial City

    Houston, Texas, 77024

  • Community Regional Cancer Care at Community Hospital East

    Indianapolis, Indiana, 46219

  • Community Regional Cancer Care at Community Hospital North

    Indianapolis, Indiana, 46256

  • University of Mississippi Cancer Clinic

    Jackson, Mississippi, 39216

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Integrated Community Oncology Network at Southside Cancer Center

    Jacksonville, Florida, 32207

  • Baptist Medical Center South

    Jacksonville, Florida, 32258

  • Integrated Community Oncology Network

    Jacksonville Beach, Florida, 32250

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007-3731

  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Kansas City Cancer Centers - South

    Kansas City, Missouri, 64131

  • Kansas City Cancer Centers - North

    Kansas City, Missouri, 64154

  • Lucille P. Markey Cancer Center at University of Kentucky

    Lexington, Kentucky, 40536-0093

  • Longview Cancer Center

    Longview, Texas, 75601

  • James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Elliot Regional Cancer Center at Elliot Hospital

    Manchester, New Hampshire, 03103

  • Hillcrest Cancer Center at Hillcrest Hospital

    Mayfield Heights, Ohio, 44124

  • Dubs Cancer Center at Rogue Valley Medical Center

    Medford, Oregon, 97504

  • Lake/University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Southwest General Health Center

    Middleburg Heights, Ohio, 44130

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226

  • Veterans Affairs Medical Center - Milwaukee

    Milwaukee, Wisconsin, 53295

  • Trinity CancerCare Center

    Minot, North Dakota, 58701

  • George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

    New Britain, Connecticut, 06050

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032

  • Methodist Estabrook Cancer Center

    Omaha, Nebraska, 68114

  • Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UHHS Chagrin Highlands Medical Center

    Orange, Ohio, 44122

  • Integrated Community Oncology Network - Orange Park

    Orange Park, Florida, 32073

  • St. Charles Mercy Hospital

    Oregon, Ohio, 43616

  • Florida Hospital Cancer Institute at Florida Hospital Orlando

    Orlando, Florida, 32803-1273

  • M.D. Anderson Cancer Center at Orlando

    Orlando, Florida, 32806

  • Kansas City Cancer Centers - Southwest

    Overland Park, Kansas, 66210

  • Florida Cancer Center - Palatka

    Palatka, Florida, 32177

  • Parma Community General Hospital

    Parma, Ohio, 44129

  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • All Saints Cancer Center at Wheaton Franciscan Healthcare

    Racine, Wisconsin, 53405

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Renown Institute for Cancer at Renown Regional Medical Center

    Reno, Nevada, 89502

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • Radiological Associates of Sacramento Medical Group, Incorporated

    Sacramento, California, 95815

  • Seton Cancer Institute at Saint Mary's - Saginaw

    Saginaw, Michigan, 48601

  • Flagler Cancer Center

    Saint Augustine, Florida, 32086

  • Cancer Care Centers of South Texas - Northeast

    San Antonio, Texas, 78217

  • North Coast Cancer Care, Incorporated

    Sandusky, Ohio, 44870

  • Texas Oncology, PA at Texas Cancer Center - Sherman

    Sherman, Texas, 75090

  • Frederick R. and Betty M. Smith Cancer Treatment Center

    Sparta, New Jersey, 07871

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Institute at St. John's Hospital

    Springfield, Illinois, 62702

  • Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, 63110

  • Barnes-Jewish West County Hospital

    St Louis, Missouri, 63141

  • Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

    Sugar Land, Texas, 77479

  • Flower Hospital Cancer Center

    Sylvania, Ohio, 43560

  • St. Anne Mercy Hospital

    Toledo, Ohio, 43623

  • Arizona Oncology - Tucson

    Tucson, Arizona, 85704

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Cancer Institute of New Jersey at Cooper - Voorhees

    Voorhees Township, New Jersey, 08043

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • UHHS Westlake Medical Center

    Westlake, Ohio, 44145

  • Texas Oncology, PA - Wichita Falls

    Wichita Falls, Texas, 76310

  • Forsyth Regional Cancer Center at Forsyth Medical Center

    Winston-Salem, North Carolina, 27103

  • Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, 27157-1096

  • Riverview UW Cancer Center at Riverview Hospital

    Wisconsin Rapids, Wisconsin, 54494

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

Other trials in United States

Canada5 sites

  • Northeastern Ontario Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • London Regional Cancer Program at London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Israel2 sites

  • Rabin Medical Center - Beilinson Campus

    Petah Tikva, 49100

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

About this study

Official title: Randomized Phase II Study Comparing Prophylactic Cranial Irradiation Alone to Prophylactic Cranial Irradiation and Consolidative Extra-Cranial Irradiation for Extensive Disease Small Cell Lung Cancer (ED-SCLC)

RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. This may be an effective treatment for extensive stage small cell lung cancer.

PURPOSE: This randomized phase II trial is comparing how well radiation therapy to the brain works when given with or without radiation therapy to other areas of the body in treating patients with extensive stage small cell lung cancer.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the 1-year overall median survival rate in patients with extensive stage small cell lung cancer treated with prophylactic cranial irradiation with vs without consolidative extracranial radiotherapy following platinum-based chemotherapy.

Secondary

  • To compare treatment-related adverse events in these patients.
  • To evaluate patterns of failure in these patients.
  • To compare the time to first failure in these patients.
  • To evaluate the percentage of the planned radiotherapy dose given to each site.

OUTLINE: This is a multicenter study. Patients are stratified according to response to prior treatment (complete response vs partial response) and number of metastatic lesions (1 vs 2-3). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo prophylactic cranial irradiation 5 days per week for 2 weeks.
  • Arm II: Patients undergo prophylactic cranial irradiation as in arm I. Patients also undergo consolidative extracranial radiotherapy to locoregional and residual metastatic disease 5 days per week for 2-3 weeks.

After completion of study treatment, patients are followed up at 2 weeks; at 1, 2, 6, 9, and 12 months; every 6 months for 2 years; and then annually thereafter.

Conditions
Lung Cancer
Being tested
Prophylactic Cranial Irradiation, Radiation Therapy
Keywords
extensive stage small cell lung cancer
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Prophylactic Cranial IrradiationRadiation

    Also called PCI

    Prophylactic Cranial Irradiation (PCI) to the brain in ten once-daily fractions of 2.5 Gy, five days per week, for a total of 25 Gy.

  • Radiation TherapyRadiation

    Also called RT

    Radiation Therapy (RT) to locoregional and residual metastatic disease in 15 once daily fractions of 3.0 Gy, 5 days per week, for a total of 45 Gy

Study groups in NCT01055197
Study groupRoleWhat they receive
PCIExperimentalProphylactic Cranial Irradiation (PCI)
Receives: Radiation: Prophylactic Cranial Irradiation
PCI + Consolidation RTExperimentalProphylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
Receives: Radiation: Prophylactic Cranial Irradiation; Radiation: Radiation Therapy

What is being measured

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

  1. Overall Survival (12-month Rate Reported)

    Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. This analysis was planned to occur when all patients had been potentially followed for at least 12 months. The 12-month rate is reported.

    Measured: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

Secondary outcomes (4)

  1. Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event

    Adverse events (AE) are graded using CTCAE v4.0. Grade refers to the severity of the AE. The CTCAE v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE.

    Measured: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

  2. Patterns of Failure - Number of Patients With Failure by Site

    Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging [per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1] and physical examination. A patient could be counted in more than one category.

    Measured: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

  3. First Failure (12-month Rate Reported)

    Failure was defined as progressive disease in areas treated with radiation development of measurable disease at sites that had achieved a complete response either with chemotherapy prior to study entry or following radiation, or development of new disease characteristic of small-cell lung cancer dissemination as determined by imaging [per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1] and physical examination. Time to first failure is defined as time from randomization to the date of first failure, last known follow-up (censored), or death (competing risk). First failure rates are estimated using the cumulative incidence method.

    Measured: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.

  4. Percentage of Planned Radiotherapy Dose (All Sites) That Was Delivered

    Total dose to the brain was to be 25 Gy for all patients. For patients on PCI+consolidative RT, patients were to get 45 Gy at 3 Gy per fraction to the locoregional area as well as to residual metastatic disease. Alternatively, these regions could have received 30-40 Gy in 10 fractions. The total planned dose was determined, and a percentage was calculated based for each patient as total delivered dose / total planned dose.

    Measured: From start to end of radiation therapy; up to 32 days for Prophylactic Cranial Irradiation arm, up to 68 days for Prophylactic Cranial Irradiation + Consolidation Radiotherapy arm.

Timeline

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

  1. First posted25 Jan 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionMar 2015
  4. Study completionDec 2016

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01055197
Sponsor's protocol ID
RTOG 0937
Other IDs
CDR0000663959, NCI-2011-02008
Status last verified
Jul 2018
First submitted
22 Jan 2010
Last updated
12 Dec 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prophylactic Cranial Irradiation and Radiation Therapy in people with Lung Cancer, run by Radiation Therapy Oncology Group at 115 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: finished, as of the sponsor's last update on 12 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 115 sites in United States, Canada, Israel. 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?

Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Survival (12-month Rate Reported) (time frame: From randomization to last follow-up. Analysis occurred after all patients had been potentially followed for at least 12 months. Maximum follow-up at time of analysis was 46.0 months.). 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 NCT01055197.

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 12 Dec 2018.

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