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NCT00003119 · CITED IN SOURCE DOCUMENTS

Surgery in Treating Children With Neuroblastoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2017-03-13

RATIONALE: Surgery alone may be effective in treating children with neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically proven low-risk neuroblastoma (excluding ganglioneuroma) * International Neuroblastoma Staging System (INSS) stage 1 in all patients * INSS stage 2A or 2B in patients less than 365 days of age * INSS stage 2A or 2B tumor with nonamplified MYCN with any Shimada histology in patients ages 1 to 20 years * INSS stage 2A or 2B tumor with amplified MYCN with Shimada favorable histology in patients ages 1 to 20 years * INSS stage 4S tumors with nonamplified MYCN, Shimada favorable histology, and a DNA index not equal to 1 in patients less than 365 days of age * Immediate chemotherapy allowed prior to biopsy for patients with intradural extension and/or emergent paresis if biopsy performed within 96 hours * Must have no abnormal organ function unless due to neuroblastoma * Concurrent registration on companion biology study (protocol COG-ANBL00B1) or its successor PATIENT CHARACTERISTICS: Age: * Under 21 Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 1.5 times normal * SGOT or SGPT less than 2.5 times normal Renal: * Creatinine less than 1.5 times normal Cardiovascular: * Shortening fraction greater than 27% by echocardiogram OR * Ejection fraction greater than 47% by radionuclide angiogram PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy Chemotherapy: * See Disease Characteristics Endocrine therapy: * No prior hormonal therapy Radiotherapy: * No prior radiotherapy Surgery: * Prior surgery allowed Other: * No other prior therapy
healthy Volunteers
false
maximum Age
21 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Procedure: conventional surgery
    2. Radiation: radiation therapy
    label
    Treatment 1 - Asymptomatic - no immediate chemotherapy
    type
    EXPERIMENTAL
  2. intervention Names
    1. Biological: filgrastim
    2. Biological: sargramostim
    3. Drug: carboplatin
    4. Drug: cyclophosphamide
    5. Drug: doxorubicin hydrochloride
    6. Drug: etoposide
    7. Procedure: adjuvant therapy
    8. Procedure: conventional surgery
    9. Radiation: radiation therapy
    label
    Symptomatic - immediate chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    filgrastim
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    sargramostim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    carboplatin
    type
    DRUG
  4. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    cyclophosphamide
    type
    DRUG
  5. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    doxorubicin hydrochloride
    type
    DRUG
  6. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    etoposide
    type
    DRUG
  7. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    name
    adjuvant therapy
    type
    PROCEDURE
  8. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    2. Treatment 1 - Asymptomatic - no immediate chemotherapy
    name
    conventional surgery
    type
    PROCEDURE
  9. arm Group Labels
    1. Symptomatic - immediate chemotherapy
    2. Treatment 1 - Asymptomatic - no immediate chemotherapy
    name
    radiation therapy
    type
    RADIATION
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
968
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The primary objective is to estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone. Under the assumption that about 90% of the low risk 2A/2B patients will be asymptomatic, and 10% of these will be lost to follow up, the projected sample size will enable estimation of the survival rate with a standard error less than .03. This sample size will also provide sufficient power for the sequential monitoring plan (see below) for this subgroup of patients.
    measure
    Estimate the 3 year survival rate for low risk asymptomatic stage 2A/2B patients who are treated with surgery alone
Full study description
brief Summary
RATIONALE: Surgery alone may be effective in treating children with neuroblastoma. PURPOSE: Phase III trial to study the effectiveness of surgery alone in treating children who have neuroblastoma.
detailed Description
OBJECTIVES: * To determine if asymptomatic patients with low-risk neuroblastoma treated with surgery alone will have a 3-year survival rate of 95%. * Estimate the response and 3-year event-free survival rates of symptomatic patients treated with chemotherapy. * Estimate the event-free survival and overall survival rates in patients who relapse or progress after initial treatment with surgery alone. * Determine the acute and chronic toxic effects associated with treating low-risk neuroblastoma with surgery alone or surgery and chemotherapy. OUTLINE: This is a multicenter study. Patients are stratified according to disease stage, MYCN status, age, and histology. Patients undergo primary tumor resection and biopsy of regional nodes. Patients with at least 50% of the tumor resected are followed monthly for 3 months, every 3 months for 9 months, every 6 months for one year, and then annually thereafter. Regimen I * Patients with clinically symptomatic (e.g., respiratory distress, spinal cord compromise with or without neurologic deficit, inferior vena cava compression with renal or bowel ischemia, intractable vomiting due to gastrointestinal obstruction, genitourinary obstruction, or coagulopathy) low-risk neuroblastoma or who have less than 50% of the primary tumor resected receive 4 different courses of chemotherapy. * Course 1: Patients receive carboplatin IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2. * Course 2: Patients receive carboplatin IV over 1 hour, cyclophosphamide IV over 1 hour, and doxorubicin IV over 15-60 minutes on day 1. * Course 3: Patients receive cyclophosphamide IV over 1 hour followed by etoposide IV over 2 hours on day 0 and etoposide only on days 1 and 2. * Course 4: Patients receive carboplatin IV over 1 hour and etoposide IV over 2 hours followed by doxorubicin IV over 15-60 minutes on day 0 and etoposide only on days 1 and 2. Regimen II * Patients who progress to or recur with unfavorable biology intermediate-risk disease receive an additional 4 courses of chemotherapy. * Course 5: Patients receive treatment as in course 3 above. * Course 6: Patients receive treatment as in course 2 above. * Course 7: Patients receive treatment as in course 1 above. * Course 8: Patients receive cyclophosphamide IV over 1 hour followed by doxorubicin IV over 15-60 minutes on day 1. All infants under 60 days of age receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24 to 36 hours after chemotherapy and continuing until blood counts recover. Courses in both regimens repeat every 3 weeks in the absence of unacceptable toxicity. Patients at risk for symptomatic spinal cord compression may also receive chemotherapy. Patients experiencing progressive or recurrent disease after observation undergo repeat surgery and/or chemotherapy as above. Patients with clinically symptomatic disease may also undergo radiotherapy if response to chemotherapy is not rapid. Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 820 patients will be accrued for this study within 4 years.
Source references
references
  1. citation
    Meany HJ, Attiyeh EF, Naranjo A, et al.: Outcome analysis of non-high-risk neuroblastoma patients enrolled on Children's Oncology Group trials P9641 and A3961. [Abstract] J Clin Oncol 30 (Suppl 15): A-9533, 2012.
    type
    BACKGROUND
  2. citation
    Attiyeh EF, Mosse YP, Diskin S, et al.: Identification of genomic DNA signatures predicting relapse in low- and intermediate- risk neuroblastoma using a case control design and high-density SNP genotyping: a Children's Oncology Group (COG) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9500, 526s, 2007.
    type
    BACKGROUND
  3. citation
    Strother DR, London WB, Schmidt ML, Brodeur GM, Shimada H, Thorner P, Collins MH, Tagge E, Adkins S, Reynolds CP, Murray K, Lavey RS, Matthay KK, Castleberry R, Maris JM, Cohn SL. Outcome after surgery alone or with restricted use of chemotherapy for patients with low-risk neuroblastoma: results of Children's Oncology Group study P9641. J Clin Oncol. 2012 May 20;30(15):1842-8. doi: 10.1200/JCO.2011.37.9990. Epub 2012 Apr 23.
    pmid
    22529259
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        endent.[<a href="#cit/section_1.100">100</a>,<a href="#cit/section_1.101">101</a>]</p> <p id="_956" tabindex="-1">A COG study (<a href="/clinicaltrials/NCT00003119">P9641 [NCT00003119]</a>) investigated the effect of histology, among other factors, on outcome. Of 915 children with stage 1 and stage 2 neuroblastoma without
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        t/section_1.100">100</a>,<a href="#cit/section_1.101">101</a>]</p> <p id="_956" tabindex="-1">A COG study (<a href="/clinicaltrials/NCT00003119">P9641 [NCT00003119]</a>) investigated the effect of histology, among other factors, on outcome. Of 915 children with stage 1 and stage 2 neuroblastoma without <em class="gene-nam
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        index="-1">Evidence (surgery followed by observation):</p> <div class="pdq-content-list"><ol id="_1916"><li>Results from the <a href="/clinicaltrials/NCT00003119">COG-P9641 (NCT00003119)</a> study showed that surgery alone, even without complete resection, can cure nearly all patients with stage 1 neuroblastoma and the
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      4. context exact
        gery followed by observation):</p> <div class="pdq-content-list"><ol id="_1916"><li>Results from the <a href="/clinicaltrials/NCT00003119">COG-P9641 (NCT00003119)</a> study showed that surgery alone, even without complete resection, can cure nearly all patients with stage 1 neuroblastoma and the vast majority of patien
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        <p id="_761" tabindex="-1">Evidence (for removal of chemotherapy):</p> <div class="pdq-content-list"><ol id="_762"><li>The <a href="/clinicaltrials/NCT00003119">COG-P9641</a> study was one of the first COG studies to test risk stratification based on consensus-derived factors. In this phase III nonrandomized trial, 91
        end
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      6. context exact
        f metastatic disease and had unfavorable biology. </li></ul></div></li><li>Eighty patients with stage 4S disease were enrolled on the <a href="/clinicaltrials/NCT00003119">COG-P9641 (NCT00003119) </a> trial. Forty-one patients with asymptomatic stage 4S neuroblastoma were treated with surgery or biopsy alone, and 39 patients wer
        end
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      7. context exact
        had unfavorable biology. </li></ul></div></li><li>Eighty patients with stage 4S disease were enrolled on the <a href="/clinicaltrials/NCT00003119">COG-P9641 (NCT00003119) </a> trial. Forty-one patients with asymptomatic stage 4S neuroblastoma were treated with surgery or biopsy alone, and 39 patients were treated with surgery a
        end
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      8. context exact
        sphamide and topotecan. The cumulative dose of each agent is kept low to minimize long-term effects, as used in previous COG trials (<a href="/clinicaltrials/NCT00003119">COG-P9641</a> and <a href="/clinicaltrials/NCT00003093">COG-A3961</a>).[<a href="#cit/section_10.16">16</a>,<a href="#cit/section_10.17">17</a>,<a href="#cit/
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        exact text
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      9. context exact
        d as low risk and younger than 1 year at recurrence may be treated according to tumor biology, as defined in the previous COG trials (<a href="/clinicaltrials/NCT00003119">COG-P9641</a> and <a href="/clinicaltrials/NCT00003093">COG-A3961</a>): </p> <div class="pdq-content-list"><ol id="_182"><li>If the biology is complet
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      source title
      Neuroblastoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 28, 2025
        datetime
        2025-04-28T12:00:00Z
        display
        April 28, 2025

    Preserved source evidence · Not medical advice