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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00376 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| AHOD03P1 | |||
| CDR0000419921 | |||
| COG-AHOD03P1 | |||
| AHOD03P1 | Other Identifier | Children's Oncology Group | |
| AHOD03P1 | Other Identifier | CTEP | |
| U10CA098543 | U.S. NIH Grant/Contract | View source | |
| U10CA180886 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
This phase II trial is studying how well surgery and/or combination chemotherapy with or without radiation therapy or observation only work in treating young patients with newly diagnosed stage I or stage II lymphocyte predominant Hodgkin disease (LPHD). Surgery may be an effective treatment for LPHD. Drugs used in chemotherapy, such as doxorubicin, vincristine, prednisone, and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) with or without radiation therapy may kill more cancer cells.
PRIMARY OBJECTIVES:
I. To preserve the excellent cure rate in patients with lymphocyte predominant Hodgkin disease (LPHD) while employing a treatment strategy that minimizes the exposure to chemotherapy and radiation therapy in appropriate patients.
II. To estimate the proportion of stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.
III. To estimate the proportions of stage I unresected, stage I resected (whose disease has recurred after observation), and stage II LPHD patients who can be cured with adriamycin (doxorubicin)/vincristine/prednisone/cyclophosphamide (AV-PC) x 3, with involved field radiation therapy (IFRT) for those who are not in a CR after chemotherapy.
IV. To reduce the potential for long-term toxicity of LPHD treatment.
OUTLINE: This is a pilot study.
Patients with stage IA disease who underwent confirmed complete resection of a single involved lymph node at diagnosis undergo observation only*.
Patients with stage IA disease who underwent possible complete resection of a single involved lymph node at diagnosis undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not demonstrate complete resection by imaging proceed to combination chemotherapy with or without radiotherapy.
Patients with stage IA disease who underwent a fine needle aspiration of a single involved lymph node OR an incomplete resection of a single involved lymph node at diagnosis may undergo a second surgery to achieve complete resection. Patients who undergo complete resection during the second surgery undergo imaging at 6-7 weeks after surgery. Patients with a confirmed complete resection by imaging undergo observation only*. Patients who do not undergo a second surgery OR do not achieve complete resection with the second surgery proceed to combination chemotherapy with or without radiotherapy. Patients with stage IA disease with involvement of more than 1 lymph node OR stage IIA disease proceed directly to combination chemotherapy with or without radiotherapy.
NOTE: *Patients with recurrent disease after observation only undergo biopsy and restaging and then proceed to combination chemotherapy with or without radiotherapy. (AS OF AMENDMENT #4, THE TREATMENT ARM FOR PATIENTS WHOSE CANCER RECURRED AFTER OBSERVATION ALONE IS NOW CLOSED)
COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone orally (PO) or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiotherapy.
INVOLVED-FIELD RADIOTHERAPY (IFRT): Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).
Patients are followed every 3 months for 2 years, every 6 months for 3 years, annually for 5 years, and then every 5 years for 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (surgery, combination chemotherapy, radiotherapy) | Experimental | COMBINATION CHEMOTHERAPY: Patients receive doxorubicin hydrochloride IV over 10-30 minutes and cyclophosphamide IV over 1 hour on day 1, vincristine IV over 1 minute on days 1 and 8, and prednisone PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiotherapy. IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Surgery | Procedure | Undergo surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Failure-free Survival (FFS) | The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause. | At 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free Survival | Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment. | At 5 years |
| Cure by Surgery Alone in Stage I Resected Patients |
Not provided
Inclusion Criteria:
Patients with newly diagnosed, previously untreated, biopsy-proven lymphocyte predominant Hodgkin disease (LPHD) are eligible for this protocol as follows:
Diagnosis of LPHD must be made using the Revised European American Lymphoma (REAL)/World Health Organization (WHO) classification criteria and will be confirmed by rapid pathology central review
Clinical stages as follows:
Patients with "B" symptoms or bulk disease are NOT eligible for this study
Slides for rapid central pathology review must be sent to the Biopathology Center (BPC)
Serum glutamic oxalo-acetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 times upper limit of normal (ULN)
Total bilirubin =< 1.5 times ULN
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min
Creatinine based on age/gender as follows:
Shortening fraction of >= 27% by echocardiogram or ejection fraction of >= 50% by multigated radionuclide angiogram (MUGA)
Lactating females must agree that they will not breastfeed a child if they are to receive chemotherapy or radiation treatment*
Female patients of childbearing potential must have a negative pregnancy test if they are to receive chemotherapy or radiation treatment*
Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method if they are to receive chemotherapy or radiation treatment*
Note: *Pregnant or breastfeeding women with stage I, single involved lymph node and confirmed (by Quality Assurance Review Center [QARC ]) total resection, are eligible for the observation arm only; no chemotherapy or radiation treatment will be administered to pregnant or breastfeeding women
No prior chemotherapy
More than 30 days since prior systemic corticosteroids
No prior radiotherapy
All patients and/or their parents or legal guardians must sign a written informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Burton E Appel | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of Alabama at Birmingham Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37505794 | Derived | Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgery or Combination Chemotherapy, With/Without Radiotherapy | Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT). IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments). doxorubicin hydrochloride: Given IV conventional surgery: Undergo surgery cyclophosphamide: Given IV prednisone: Given IV or PO vincristine sulfate: Given IV radiation therapy: Undergo IFRT |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Cyclophosphamide | Drug | Given IV |
|
|
| Doxorubicin Hydrochloride | Drug | Given IV |
|
|
| Prednisone | Drug | Given IV or PO |
|
|
| Radiation Therapy | Radiation | Undergo IFRT |
|
|
| Vincristine Sulfate | Drug | Given IV |
|
|
To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone.
| At 2 years |
| Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients | To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy. | At 5 years |
| Grade 3 or 4 Toxicity | Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days. |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | United States |
| Banner University Medical Center - Tucson | Tucson | Arizona | 85719 | United States |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | United States |
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | United States |
| Miller Children's and Women's Hospital Long Beach | Long Beach | California | 90806 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| UCSF Benioff Children's Hospital Oakland | Oakland | California | 94609 | United States |
| Kaiser Permanente-Oakland | Oakland | California | 94611 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| Sutter Medical Center Sacramento | Sacramento | California | 95816 | United States |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | United States |
| UCSF Medical Center-Mount Zion | San Francisco | California | 94115 | United States |
| UCSF Medical Center-Parnassus | San Francisco | California | 94143 | United States |
| Harbor-University of California at Los Angeles Medical Center | Torrance | California | 90502 | United States |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | United States |
| Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver | Colorado | 80218 | United States |
| University of Connecticut | Farmington | Connecticut | 06030 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Yale University | New Haven | Connecticut | 06520 | United States |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Lee Memorial Health System | Fort Myers | Florida | 33901 | United States |
| UF Health Cancer Institute - Gainesville | Gainesville | Florida | 32610 | United States |
| Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood | Florida | 33021 | United States |
| Nemours Children's Clinic-Jacksonville | Jacksonville | Florida | 32207 | United States |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | United States |
| Miami Cancer Institute | Miami | Florida | 33176 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | United States |
| Orlando Health Cancer Institute | Orlando | Florida | 32806 | United States |
| Nemours Children's Hospital | Orlando | Florida | 32827 | United States |
| Sacred Heart Hospital | Pensacola | Florida | 32504 | United States |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa | Florida | 33607 | United States |
| Saint Mary's Medical Center | West Palm Beach | Florida | 33407 | United States |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | United States |
| Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta | Georgia | 30329 | United States |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| University of Hawaii Cancer Center | Honolulu | Hawaii | 96813 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Lurie Children's Hospital-Chicago | Chicago | Illinois | 60611 | United States |
| University of Illinois | Chicago | Illinois | 60612 | United States |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
| Advocate Children's Hospital-Oak Lawn | Oak Lawn | Illinois | 60453 | United States |
| Advocate Children's Hospital-Park Ridge | Park Ridge | Illinois | 60068 | United States |
| Advocate Lutheran General Hospital | Park Ridge | Illinois | 60068 | United States |
| Saint Jude Midwest Affiliate | Peoria | Illinois | 61637 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62702 | United States |
| Indiana University/Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | United States |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| Eastern Maine Medical Center | Bangor | Maine | 04401 | United States |
| Sinai Hospital of Baltimore | Baltimore | Maryland | 21215 | United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| C S Mott Children's Hospital | Ann Arbor | Michigan | 48109 | United States |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Michigan State University | East Lansing | Michigan | 48823 | United States |
| Hurley Medical Center | Flint | Michigan | 48503 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| Bronson Methodist Hospital | Kalamazoo | Michigan | 49007 | United States |
| Kalamazoo Center for Medical Studies | Kalamazoo | Michigan | 49008 | United States |
| Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis | Minnesota | 55404 | United States |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Children's Hospital and Medical Center of Omaha | Omaha | Nebraska | 68114 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon | New Hampshire | 03756 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Morristown Medical Center | Morristown | New Jersey | 07960 | United States |
| Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | United States |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | United States |
| Saint Joseph's Regional Medical Center | Paterson | New Jersey | 07503 | United States |
| Overlook Hospital | Summit | New Jersey | 07902 | United States |
| University of New Mexico Cancer Center | Albuquerque | New Mexico | 87106 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Brooklyn Hospital Center | Brooklyn | New York | 11201 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | United States |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| State University of New York Upstate Medical University | Syracuse | New York | 13210 | United States |
| Montefiore Medical Center - Moses Campus | The Bronx | New York | 10467 | United States |
| New York Medical College | Valhalla | New York | 10595 | United States |
| UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | 27599 | United States |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | United States |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| East Carolina University | Greenville | North Carolina | 27834 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
| Dayton Children's Hospital | Dayton | Ohio | 45404 | United States |
| ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo | Ohio | 43606 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Legacy Emanuel Hospital and Health Center | Portland | Oregon | 97227 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Milton S Hershey Medical Center | Hershey | Pennsylvania | 17033-0850 | United States |
| Penn State Children's Hospital | Hershey | Pennsylvania | 17033 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Prisma Health Richland Hospital | Columbia | South Carolina | 29203 | United States |
| BI-LO Charities Children's Cancer Center | Greenville | South Carolina | 29605 | United States |
| Greenville Cancer Treatment Center | Greenville | South Carolina | 29605 | United States |
| Sanford USD Medical Center - Sioux Falls | Sioux Falls | South Dakota | 57117-5134 | United States |
| T C Thompson Children's Hospital | Chattanooga | Tennessee | 37403 | United States |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | United States |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Texas Tech University Health Sciences Center-Amarillo | Amarillo | Texas | 79106 | United States |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | United States |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | United States |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | United States |
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Covenant Children's Hospital | Lubbock | Texas | 79410 | United States |
| Methodist Children's Hospital of South Texas | San Antonio | Texas | 78229 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | United States |
| Scott and White Memorial Hospital | Temple | Texas | 76508 | United States |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | United States |
| University of Vermont and State Agricultural College | Burlington | Vermont | 05405 | United States |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98105 | United States |
| Providence Sacred Heart Medical Center and Children's Hospital | Spokane | Washington | 99204 | United States |
| West Virginia University Charleston Division | Charleston | West Virginia | 25304 | United States |
| Cabell-Huntington Hospital | Huntington | West Virginia | 25701 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| The Children's Hospital at Westmead | Westmead | New South Wales | 2145 | Australia |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Brisbane and Women's Hospital | Herston | Queensland | 4029 | Australia |
| Women's and Children's Hospital-Adelaide | North Adelaide | South Australia | 5006 | Australia |
| Princess Margaret Hospital for Children | Perth | Western Australia | 6008 | Australia |
| Alberta Children's Hospital | Calgary | Alberta | T3B 6A8 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| British Columbia Children's Hospital | Vancouver | British Columbia | V6H 3V4 | Canada |
| CancerCare Manitoba | Winnipeg | Manitoba | R3E 0V9 | Canada |
| Janeway Child Health Centre | St. John's | Newfoundland and Labrador | A1B 3V6 | Canada |
| IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| McMaster Children's Hospital at Hamilton Health Sciences | Hamilton | Ontario | L8N 3Z5 | Canada |
| Kingston Health Sciences Centre | Kingston | Ontario | K7L 2V7 | Canada |
| Children's Hospital of Eastern Ontario | Ottawa | Ontario | K1H 8L1 | Canada |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | H3T 1C5 | Canada |
| Allan Blair Cancer Centre | Regina | Saskatchewan | S4T 7T1 | Canada |
| Saskatoon Cancer Centre | Saskatoon | Saskatchewan | S7N 4H4 | Canada |
| CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Québec | G1V 4G2 | Canada |
| Schneider Children's Medical Center of Israel | Petah Tikua | 49202 | Israel |
| Starship Children's Hospital | Grafton | Auckland | 1145 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| San Jorge Children's Hospital | San Juan | 00912 | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Surgery or Combination Chemotherapy, With/Without Radiotherapy | Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT). IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments). doxorubicin hydrochloride: Given IV conventional surgery: Undergo surgery cyclophosphamide: Given IV prednisone: Given IV or PO vincristine sulfate: Given IV radiation therapy: Undergo IFRT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Failure-free Survival (FFS) | The time to a treatment (strategy) failure, where failure includes one of the following occurrences as a first event: disseminated disease (> Stage I/II) progression or recurrence at any time, local disease progression or recurrence anytime during or after treatment with AV-PC +/- IFRT, occurrence of a second malignant neoplasm, death from any cause. | Of 188 patients enrolled, five ineligible patients and five patients who did not receive the upfront chemotherapy +/- RT per protocol were excluded from this analysis. 178 patients are included. The median follow-up for the 164 censored patients is 61.2 (range 3.5-107.4) months. | Posted | Number | 95% Confidence Interval | Probability participants | At 5 years |
|
|
| |||||||||||||||||||||||||
| Secondary | Event-free Survival | Failure includes one of the following occurrences as a first event: relapse/progression or second malignancy from enrollment. | Of 188 patients enrolled, five ineligible patients were excluded from this analysis. 183 patients are included. The median follow-up time for the 155 censored patients is 61.2 months (range 0.03-107.4). | Posted | Number | 95% Confidence Interval | Probability participants | At 5 years |
|
| ||||||||||||||||||||||||||
| Secondary | Cure by Surgery Alone in Stage I Resected Patients | To estimate the proportion of Stage I patients (with a single involved lymph node that is totally resected) who can be cured with surgery alone. | Of 188 patients enrolled, five ineligible patients were excluded. 52 patients with Stage IA, single node LPHL were enrolled with a confirmed total resection (TR). The median follow up among the 39 censored patients is 56.3 months (range 3.9-107.4). | Posted | Number | 95% Confidence Interval | Probability participants | At 2 years |
| |||||||||||||||||||||||||||
| Secondary | Cure by AV-PC x 3 or AV-PC x 3 + IFRT for Stage I Unresected, Stage I Resected Whose Disease Recurred, and Stage II Patients | To estimate the proportions of Stage I unresected, Stage I resected (whose disease has recurred after observation), and Stage II LPHD patients who can be cured with AV-PC x 3, with IFRT for those who are not in a CR after chemotherapy. | Of 188 patients enrolled, five ineligible patients were excluded. 136 patients received upfront AV-PC with or without RT per protocol. Of these 135 achieved CR with AV-PC and avoided RT. The median follow up among the 121 censored patients is 62.2 months (range 3.4-104.5). | Posted | Number | 95% Confidence Interval | Probability participants | At 5 years |
| |||||||||||||||||||||||||||
| Secondary | Grade 3 or 4 Toxicity | Eligible patients beginning AV-PC. | Posted | Number | Participants | Any time during chemoradiotherapy, up to the end of 3-cycles of AV-PC induction. Each cycle is 21 days. |
|
|
Not provided
For both Serious and Other: Adverse event incidence among 183 eligible participants. This is 188 enrolled less 5 that are ineligible. There were no (0) serious adverse events reported.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Surgery or Combination Chemotherapy, With/Without Radiotherapy | Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT). IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments). doxorubicin hydrochloride: Given IV conventional surgery: Undergo surgery cyclophosphamide: Given IV prednisone: Given IV or PO vincristine sulfate: Given IV radiation therapy: Undergo IFRT | 0 | 183 | 26 | 183 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Vomiting | Gastrointestinal disorders |
| |||
| Catheter related infection | Infections and infestations |
| |||
| Device related infection | Infections and infestations |
| |||
| Infections and infestations - Other, specify | Infections and infestations |
| |||
| Upper respiratory infection | Infections and infestations |
| |||
| Alanine aminotransferase increased | Investigations |
| |||
| Lipase increased | Investigations |
| |||
| Neutrophil count decreased | Investigations |
| |||
| White blood cell decreased | Investigations |
| |||
| Anorexia | Metabolism and nutrition disorders |
| |||
| Dehydration | Metabolism and nutrition disorders |
| |||
| Hypercalcemia | Metabolism and nutrition disorders |
| |||
| Hypokalemia | Metabolism and nutrition disorders |
| |||
| Arthralgia | Musculoskeletal and connective tissue disorders |
| |||
| Pain in extremity | Musculoskeletal and connective tissue disorders |
| |||
| Extrapyramidal disorder | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Personality change | Psychiatric disorders |
|
Must obtain prior Sponsor approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Results Reporting Coordinator | Children's Oncology Group | 626-447-0064 | resultsreportingcoordinator@childrensoncologygroup.org |
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D011241 | Prednisone |
| C407664 | deltacortene |
| C036266 | prednylidene |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D013812 | Therapeutics |
| D055585 | Physical Phenomena |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Israel |
|
| Australia |
|
| Puerto Rico |
|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
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