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Completed

NCT Number: NCT00006461

Combination Chemotherapy Followed by Second-Look Surgery and Radiation Therapy in Treating Children With Nonmetastatic Medulloblastoma or Primitive Neuroectodermal Tumor

This phase III trial is studying how well combination chemotherapy followed by second-look surgery and radiation therapy works in treating children with nonmetastatic medulloblastoma or primitive neuroectodermal tumor. Drugs used in chemotherapy use 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. Combining more than one drug and combining chemotherapy with surgery and radiation therapy may kill more tumor cells.

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Key information

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children's Oncology Group

Arcadia, California, 91006-3776, United States

About this study

PRIMARY OBJECTIVES:

I. To determine if the proposed treatment for children >= 8.0 months and < 3 years of age at registration with non-metastatic (M0) medulloblastoma is more effective than the combined treatments given to children of the same age and extent of disease on POG 9233, as measured by event-free survival (EFS) rates.

SECONDARY OBJECTIVES:

I. To assess the feasibility and safety of the planned use of second look surgery and focal conformal radiation therapy following chemotherapy. II. To determine the acute and chronic toxicities associated with the above treatment regimens.

III. To describe the neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation. IV. To determine the feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations. V. To determine the incidence of atypical teratoid/rhabdoid tumor (AT/RT) in children enrolled on this study.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy consisting of vincristine IV on days 1, 8, and 15; cisplatin IV over 6 hours on day 1; cyclophosphamide IV over 30 minutes on day 2; and oral etoposide daily on days 2-22. Treatment repeats every 28 days for a total of 4 courses. After completion of induction chemotherapy, patients with residual disease undergo a second resection. Within 4 weeks after completion of induction chemotherapy or second resection, patients receive focal conformal radiotherapy daily, 5 days a week, for 6 weeks. Four weeks after completion of radiotherapy, patients receive alternating treatments of maintenance chemotherapy. Patients receive vincristine IV on days 1, 8, and 15 and cyclophosphamide IV over 30 minutes on day 1 of courses 1, 3, 5, and 7 and oral etoposide daily on days 1-21 of courses 2, 4, 6, and 8. Treatment continues every 28 days for 8 courses. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed primary medulloblastoma or posterior fossa primitive neuroectodermal tumor
  • Prior definitive tumor resection within 6 weeks of study
  • No evidence of metastases
  • Hemoglobin at least 10 g/dL
  • Absolute neutrophil count at least 1,500/mm3
  • Platelet count at least 100,000/mm3
  • AST less than 2.5 times normal
  • Bilirubin less than 1.5 mg/dL
  • Creatinine less than 1.2 mg/dL
  • Creatinine clearance greater than 70 mL/min
  • No prior chemotherapy
  • No prior radiotherapy
  • See Disease Characteristics

Treatment and study plan

Cisplatin

Drug

Given IV

Other names: CACP, CDDP, CPDD, DDP

Cyclophosphamide

Drug

Given IV

Other names: CPM, CTX, Cytoxan, Endoxan, Endoxana

vincristine sulfate

Drug

Given IV

Other names: leurocristine sulfate, VCR, Vincasar PFS

etoposide

Drug

Given PO

Other names: EPEG, VP-16, VP-16-213

therapeutic conventional surgery

Procedure

Undergo surgery

3-Dimensional Conformal Radiation Therapy

Radiation

Undergo 3-dimensional conformal radiation therapy

Other names: 3D conformal radiation therapy, 3D-CRT

Primary outcomes

  1. Event-free survival rate

    Time frame: 1 year

Secondary outcomes

  1. Acute and chronic toxicities associated with the treatment regimens

    Time frame: Up to 9 years

  2. Neuropsychological and neuroendocrine effects of this systemic chemotherapy, surgery, and local, conformal radiation

    Time frame: Up to 9 years

  3. Feasibility and validity of a centralized telephone interview based data collection method for neuropsychological evaluations

    Time frame: Up to 9 years

  4. Incidence of atypical teratoid and/or rhabdoid tumor

    Time frame: Up to 9 years

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Systemic Chemotherapy, Second Look Surgery and Conformal Radiation Therapy Limited to the Posterior Fossa and Primary Site for Children &gt;/= to 8 Months and &lt;3 Years With Non-metastatic Medulloblastoma: A Children&Apos;s Oncology Group Phase III Study

Important dates

Study start
2000
Primary completion
2007
First posted
Jan 27, 2003
Registry last updated
Aug 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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