Skip to content
Triangle logo TriangleGet started
← Study library

NCT00002995 · CITED IN SOURCE DOCUMENTS

Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma

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
2014-02-14

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.

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 confirmed embryonal (EMB) rhabdomyosarcoma (RMS) or botryoid or spindle cell variants of EMB RMS or embryonal ectomesenchymoma meeting 1 of the following criteria: * Stage 1, no clinical group IV: Tumor in favorable site (orbit, head and neck \[excluding parameningeal\], genitourinary \[not bladder/prostate\], or biliary tract) and no metastatic disease * Stage 2 or 3, clinical group I or II: Tumor in unfavorable site (bladder/prostate, extremity, cranial parameningeal, trunk, retroperitoneum, pelvis, perineal/perianal, intrathoracic, gastrointestinal, or liver), no gross residual disease after initial surgery, and no metastatic disease * Must have ipsilateral lymph node dissection if age 10 or over with primary paratesticular cancer OR under age 10 with clinically positive regional lymph nodes * Low risk of recurrence * Previously untreated disease * No alveolar RMS or undifferentiated sarcoma * No intermediate-risk disease * No metastatic disease at diagnosis PATIENT CHARACTERISTICS: Age: * Under 50 Performance status: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin elevation secondary to biliary or hepatic primaries allowed Renal: * Creatinine elevation secondary to tumor obstruction allowed Other: * No uncontrolled infection * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
healthy Volunteers
false
maximum Age
49 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
interventions
  1. name
    dactinomycin
    type
    BIOLOGICAL
  2. name
    filgrastim
    type
    BIOLOGICAL
  3. name
    sargramostim
    type
    BIOLOGICAL
  4. name
    cyclophosphamide
    type
    DRUG
  5. name
    vincristine sulfate
    type
    DRUG
  6. name
    radiation therapy
    type
    RADIATION
Study design
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
483
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Failure-free survival
Full study description
brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether chemotherapy is more effective with or without radiation therapy in treating patients who have rhabdomyosarcoma. PURPOSE: Phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy in treating patients who have newly-diagnosed rhabdomyosarcoma.
detailed Description
OBJECTIVES: * Determine the failure-free survival (FFS) rate in patients with newly diagnosed low-risk rhabdomyosarcoma of embryonal or botryoid subtype meeting criteria for group I after treatment with dactinomycin and vincristine with or without radiotherapy. * Determine the FFS rate in these patients meeting criteria for group II after treatment with dactinomycin, vincristine, and cyclophosphamide with or without radiotherapy. * Determine the FFS rate in patients with ectomesenchymomas containing rhabdomyosarcomatous elements (embryonal histiotype) who receive one of the above treatments. * Determine new molecular markers specific to embryonal and botryoid tumor histologies which are of diagnostic and prognostic significance in patients treated with these regimens. OUTLINE: Patients are assigned to 1 of 2 groups, depending on histology and site of disease. * Group I (favorable tumor site, negative lymph nodes, stage 1, clinical group I, IIA, or III (orbit only), node negative \[N0\] OR unfavorable tumor site, negative or unknown lymph nodes, stage 2, clinical group I): Patients receive vincristine IV over 1 minute weekly for 8 weeks and dactinomycin IV over 1 minute once every 3 weeks for 4 doses. Treatment repeats every 12 weeks for 4 courses. Radiotherapy is administered to patients with clinical group II or III disease on weeks 3-8. * Group II (favorable tumor site, positive lymph nodes, stage 1, clinical group III (orbit only), node positive \[N1\] OR favorable tumor site except orbit, any lymph nodes, stage 1, clinical group III OR unfavorable tumor site, stage 2, clinical group II OR unfavorable tumor site, stage 3, clinical group I or II): Patients receive vincristine and dactinomycin as in group I. Patients also receive cyclophosphamide IV over 30-60 minutes and filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously once daily beginning 24 hours after completion of chemotherapy and continuing for 10 days or until blood counts recover. Radiotherapy is administered on weeks 3-8, 12-17, or 28-33, if clinically indicated as in group I. Patients are followed every 3-4 months for 3 years (4 years after diagnosis), every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 254 patients for group I will be accrued for this study within 6 years. Approximately 12 patients per year will be accrued for group II.
Source references
references
  1. citation
    Malempati S, Rodeberg DA, Donaldson SS, Lyden ER, Anderson JR, Hawkins DS, Arndt CA. Rhabdomyosarcoma in infants younger than 1 year: a report from the Children's Oncology Group. Cancer. 2011 Aug 1;117(15):3493-501. doi: 10.1002/cncr.25887. Epub 2011 Jan 24.
    pmid
    21264837
    type
    BACKGROUND
  2. citation
    Walterhouse DO, Meza JL, Breneman JC, Donaldson SS, Hayes-Jordan A, Pappo AS, Arndt C, Raney RB, Meyer WH, Hawkins DS. Local control and outcome in children with localized vaginal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma committee of the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 15;57(1):76-83. doi: 10.1002/pbc.22928. Epub 2011 Feb 4.
    pmid
    21298768
    type
    BACKGROUND
  3. citation
    Breneman J, Meza J, Donaldson SS, Raney RB, Wolden S, Michalski J, Laurie F, Rodeberg DA, Meyer W, Walterhouse D, Hawkins DS. Local control with reduced-dose radiotherapy for low-risk rhabdomyosarcoma: a report from the Children's Oncology Group D9602 study. Int J Radiat Oncol Biol Phys. 2012 Jun 1;83(2):720-6. doi: 10.1016/j.ijrobp.2011.06.2011. Epub 2011 Nov 19.
    pmid
    22104356
    type
    RESULT
  4. citation
    Raney RB, Walterhouse DO, Meza JL, Andrassy RJ, Breneman JC, Crist WM, Maurer HM, Meyer WH, Parham DM, Anderson JR. Results of the Intergroup Rhabdomyosarcoma Study Group D9602 protocol, using vincristine and dactinomycin with or without cyclophosphamide and radiation therapy, for newly diagnosed patients with low-risk embryonal rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2011 Apr 1;29(10):1312-8. doi: 10.1200/JCO.2010.30.4469. Epub 2011 Feb 28.
    pmid
    21357783
    type
    RESULT
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-7ad944f6deaf1f5cd6122126
      edge id
      nct-edge-378441561729f8f48d9c
      requested nct id
      NCT00002995
      primary nct id
      NCT00002995
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source file sha256
      3e253a588554150bd5ae5ac665bdef96fb4f453120bd18f9dde0221d2dbf3739
      payload sha256
      5b7df6bde8d7f66a9cf3f5ed7838d57427ea2fd5ecea68e3e955a624ce12169c
      payload
      clinical indication matching status
      not_inferred
      end exclusive
      true
      id
      nct-edge-378441561729f8f48d9c
      link basis
      explicit_NCT_identifier_in_acquired_source
      nct id
      NCT00002995
      occurrences
      1. context exact
        tion_6.9">9</a>] Subsequently, delayed primary excision was evaluated by the Soft Tissue Sarcoma Committee of the COG (COG-STS) in the <a href="/clinicaltrials/NCT00002995">D9602</a> and <a href="/clinicaltrials/NCT00003958">D9803</a> studies.[<a href="#cit/section_6.8">8</a>] Delayed primary excision at week 12 after induction
        end
        249966
        exact text
        NCT00002995
        start
        249955
      2. context exact
        ive margins (R0 resection), and 41.4 Gy if the margins were microscopically involved (R1 resection) or the nodes were positive. In the <a href="/clinicaltrials/NCT00002995">COG-D9602</a> study, a limited number of low-risk patients had a greater than 85% likelihood of local control with 36 Gy.[<a href="#cit/section_6.9">9</a>] Si
        end
        267840
        exact text
        NCT00002995
        start
        267829
      3. context exact
        2 patients with low-risk orbital rhabdomyosarcoma (clinical groups I&#8211;III with mostly embryonal histology treated on the low-risk <a href="/clinicaltrials/NCT00002995">D9602</a> and <a href="/clinicaltrials/NCT00075582">ARST0331</a> studies) had 10-year EFS and OS rates of 85.5% (95% CI, 77.0%&#8211;94.0%) and 95.6% (95% CI,
        end
        288619
        exact text
        NCT00002995
        start
        288608
      4. context exact
        chemotherapy and delayed surgery.</li></ul></div></li><li>A COG analysis of 17 patients enrolled in two consecutive low-risk studies (<a href="/clinicaltrials/NCT00002995">D9602</a> and <a href="/clinicaltrials/NCT00075582">ARST0331</a>) reported the following results:[<a href="#cit/section_6.114">114</a>]<div class="pdq-content
        end
        315993
        exact text
        NCT00002995
        start
        315982
      5. context exact
        ></ul></div></li><li>The COG reviewed 279 patients with localized paratesticular rhabdomyosarcoma enrolled in one of four COG studies (<a href="/clinicaltrials/NCT00002995">D9602</a>, <a href="/clinicaltrials/NCT00075582">ARST0331</a>, <a href="/clinicaltrials/NCT00003958">D9803</a>, or <a href="/clinicaltrials/NCT00354835">ARST0
        end
        331046
        exact text
        NCT00002995
        start
        331035
      6. context exact
        le outcomes have typically been excellent, some subgroups of low-risk patients have received relatively aggressive therapy. In the COG <a href="/clinicaltrials/NCT00002995">D9602</a> and <a href="/clinicaltrials/NCT00075582">ARST0331</a> studies, low-risk patients had localized (nonmetastatic) embryonal histology tumors in favo
        end
        358541
        exact text
        NCT00002995
        start
        358530
      7. context exact
        1" tabindex="-1">Evidence (chemotherapy for low-risk Group patients):</p> <div class="pdq-content-list"><ol id="_2071"><li>The <a href="/clinicaltrials/NCT00002995">COG-D9602</a> study stratified 388 patients with low-risk embryonal rhabdomyosarcoma into two groups.[<a href="#cit/section_6.173">173</a>] Treatment for sub
        end
        359826
        exact text
        NCT00002995
        start
        359815
      8. context exact
        up III orbital tumors. This noninferiority trial used a fixed outcome on the basis of expected FFS for similar patients treated in the <a href="/clinicaltrials/NCT00002995">D9602</a> trial.[<a href="#cit/section_6.55">55</a>]<div class="pdq-content-list"><ul id="_1980"><li>There were 35 treatment failures observed (48.8 expected)
        end
        363338
        exact text
        NCT00002995
        start
        363327
      offset unit
      unicode_code_points
      source file
      /tmp/cancer-full-research/nci/raw/63d8e64beb9c88f092.html
      source file sha256
      3e253a588554150bd5ae5ac665bdef96fb4f453120bd18f9dde0221d2dbf3739
      source json pointer
      Source null
      source kind
      nci_explicit_reference_or_link
      source record id
      Source null
      source retrieved at
      2026-09-09T23:22:20.508284+00:00
      source string basis
      UTF-8_text_with_universal_newline_translation
      source string sha256
      6f71654db32394dcd1834a8ce9f674ddb7f238c7b083f23eec93a3611ef198a7
      source title
      Childhood Rhabdomyosarcoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 11, 2025
        datetime
        2025-04-11T12:00:00Z
        display
        April 11, 2025

    Preserved source evidence · Not medical advice