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

NCT01055197 | Completed Phase 2 Results DMC

• 3 other identifiers: RTOG 0937CDR0000663959NCI-2011-02008
• Study Type: interventional
• Target: 97
• Locations: 3 countries
• Sites: 115

Brief 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 body in treating patients with extensive stage small cell lung cancer.

Conditions

Lung Cancer

Keywords

extensive stage small cell lung cancer

Outcome Measures

Primary Outcomes (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.

  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)

• Percentage of Patients Experiencing a Grade 3 or Higher Adverse Event

  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.

• Patterns of Failure - Number of Patients With Failure by Site

  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.

• First Failure (12-month Rate Reported)

  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.

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

  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.

Study Arms (2)

PCI

EXPERIMENTAL

Prophylactic Cranial Irradiation (PCI)

Radiation: Prophylactic Cranial Irradiation

PCI + Consolidation RT

EXPERIMENTAL

Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease

Radiation: Prophylactic Cranial Irradiation; Radiation: Radiation Therapy

Interventions

Prophylactic Cranial Irradiation RADIATION

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.

Also known as: PCI

PCI; PCI + Consolidation RT

Radiation Therapy RADIATION

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

Also known as: RT

PCI + Consolidation RT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead
• National Cancer Institute (NCI): collaborator
• NRG Oncology: collaborator

Study Sites (115)

Arizona Oncology - Tucson

Tucson, Arizona, 85704, United States

Location

Saint Agnes Cancer Center at Saint Agnes Medical Center

Fresno, California, 93720, United States

Location

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento, California, 95815, United States

Location

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, 80933, United States

Location

Poudre Valley Radiation Oncology

Fort Collins, Colorado, 80528, United States

Location

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

Hartford, Connecticut, 06105, United States

Location

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

New Britain, Connecticut, 06050, United States

Location

University of Florida Shands Cancer Center

Gainesville, Florida, 32610-0232, United States

Location

Baptist Cancer Institute - Jacksonville

Jacksonville, Florida, 32207, United States

Location

Integrated Community Oncology Network at Southside Cancer Center

Jacksonville, Florida, 32207, United States

Location

Baptist Medical Center South

Jacksonville, Florida, 32258, United States

Location

Integrated Community Oncology Network

Jacksonville Beach, Florida, 32250, United States

Location

Integrated Community Oncology Network - Orange Park

Orange Park, Florida, 32073, United States

Location

Florida Hospital Cancer Institute at Florida Hospital Orlando

Orlando, Florida, 32803-1273, United States

Location

M.D. Anderson Cancer Center at Orlando

Orlando, Florida, 32806, United States

Location

Florida Cancer Center - Palatka

Palatka, Florida, 32177, United States

Location

Flagler Cancer Center

Saint Augustine, Florida, 32086, United States

Location

Georgia Cancer Center for Excellence at Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Emory Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Cancer Institute at St. John's Hospital

Springfield, Illinois, 62702, United States

Location

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

Anderson, Indiana, 46016, United States

Location

Radiation Oncology Associates Southwest

Fort Wayne, Indiana, 46804, United States

Location

Parkview Regional Cancer Center at Parkview Health

Fort Wayne, Indiana, 46805, United States

Location

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, 46526, United States

Location

Community Regional Cancer Care at Community Hospital East

Indianapolis, Indiana, 46219, United States

Location

Community Regional Cancer Care at Community Hospital North

Indianapolis, Indiana, 46256, United States

Location

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

Kansas City, Kansas, 66160-7357, United States

Location

Kansas City Cancer Centers - Southwest

Overland Park, Kansas, 66210, United States

Location

Lucille P. Markey Cancer Center at University of Kentucky

Lexington, Kentucky, 40536-0093, United States

Location

James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202, United States

Location

St. Agnes Hospital Cancer Center

Baltimore, Maryland, 21229, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Hickman Cancer Center at Bixby Medical Center

Adrian, Michigan, 49221, United States

Location

Henry Ford Macomb Hospital

Clinton Township, Michigan, 48038, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Genesys Hurley Cancer Institute

Flint, Michigan, 48503, United States

Location

Butterworth Hospital at Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

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

Grosse Pointe Woods, Michigan, 48236, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Seton Cancer Institute at Saint Mary's - Saginaw

Saginaw, Michigan, 48601, United States

Location

St. John Macomb Hospital

Warren, Michigan, 48093, United States

Location

University of Mississippi Cancer Clinic

Jackson, Mississippi, 39216, United States

Location

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau, Missouri, 63703, United States

Location

Kansas City Cancer Centers - South

Kansas City, Missouri, 64131, United States

Location

Kansas City Cancer Centers - North

Kansas City, Missouri, 64154, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Barnes-Jewish West County Hospital

St Louis, Missouri, 63141, United States

Location

Methodist Estabrook Cancer Center

Omaha, Nebraska, 68114, United States

Location

Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Renown Institute for Cancer at Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Elliot Regional Cancer Center at Elliot Hospital

Manchester, New Hampshire, 03103, United States

Location

Frederick R. and Betty M. Smith Cancer Treatment Center

Sparta, New Jersey, 07871, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

New York Oncology Hematology, PC at Albany Regional Cancer Care

Albany, New York, 12206, United States

Location

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

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

Rochester, New York, 14642, United States

Location

Forsyth Regional Cancer Center at Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Trinity CancerCare Center

Minot, North Dakota, 58701, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44307, United States

Location

Summa Center for Cancer Care at Akron City Hospital

Akron, Ohio, 44309-2090, United States

Location

Barberton Citizens Hospital

Barberton, Ohio, 44203, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

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

Columbus, Ohio, 43210-1240, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Southwest General Health Center

Middleburg Heights, Ohio, 44130, United States

Location

UHHS Chagrin Highlands Medical Center

Orange, Ohio, 44122, United States

Location

St. Charles Mercy Hospital

Oregon, Ohio, 43616, United States

Location

Parma Community General Hospital

Parma, Ohio, 44129, United States

Location

North Coast Cancer Care, Incorporated

Sandusky, Ohio, 44870, United States

Location

Flower Hospital Cancer Center

Sylvania, Ohio, 43560, United States

Location

St. Anne Mercy Hospital

Toledo, Ohio, 43623, United States

Location

UHHS Westlake Medical Center

Westlake, Ohio, 44145, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Natalie Warren Bryant Cancer Center at St. Francis Hospital

Tulsa, Oklahoma, 74136, United States

Location

Three Rivers Community Hospital

Grants Pass, Oregon, 97527, United States

Location

Dubs Cancer Center at Rogue Valley Medical Center

Medford, Oregon, 97504, United States

Location

Northeast Radiation Oncology Center

Dunmore, Pennsylvania, 18512, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57701, United States

Location

Texas Oncology, PA at Texas Cancer Center - Arlington South

Arlington, Texas, 76014, United States

Location

Texas Oncology, PA at Texas Cancer Center - Denton South

Denton, Texas, 76210, United States

Location

Klabzuba Cancer Center at Harris Methodist Fort Worth Hospital

Fort Worth, Texas, 76104, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0361, United States

Location

Memorial Hermann Hospital - Memorial City

Houston, Texas, 77024, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

Cancer Care Centers of South Texas - Northeast

San Antonio, Texas, 78217, United States

Location

Texas Oncology, PA at Texas Cancer Center - Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology, PA at Texas Oncology Cancer Center Sugar Land

Sugar Land, Texas, 77479, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology, PA - Wichita Falls

Wichita Falls, Texas, 76310, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Veterans Affairs Medical Center - Milwaukee

Milwaukee, Wisconsin, 53295, United States

Location

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine, Wisconsin, 53405, United States

Location

Riverview UW Cancer Center at Riverview Hospital

Wisconsin Rapids, Wisconsin, 54494, United States

Location

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

London Regional Cancer Program at London Health Sciences Centre

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Allan Blair Cancer Centre at Pasqua Hospital

Regina, Saskatchewan, S4T 7T1, Canada

Location

Rabin Medical Center - Beilinson Campus

Petah Tikva, 49100, Israel

Location

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Limitations and Caveats

At the first interim analysis of overall survival the data monitoring committee determined that due to the lack of evidence of potential efficacy and a higher than acceptable toxicity profile for the PCI+RT arm, study accrual would close early.

Results Point of Contact

• Title: Wendy Seiferheld, M.S.
• Organization: NRG Oncology

seiferheldw@nrgoncology.org

Study Officials

• Elizabeth M. Gore, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

• Alexander Sun, MD

  Princess Margaret Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 25, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 12, 2018
• Results First Posted: October 21, 2016

Record last verified: 2018-07

Locations

US (108); CA (5); IL (2)