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Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma


Phase 3
N/A
49 Years
Not Enrolling
Both
Adult Malignant Mesenchymoma, Adult Rhabdomyosarcoma, Alveolar Childhood Rhabdomyosarcoma, Childhood Malignant Mesenchymoma, Embryonal Childhood Rhabdomyosarcoma, Embryonal-botryoid Childhood Rhabdomyosarcoma, Nonmetastatic Childhood Soft Tissue Sarcoma, Previously Untreated Childhood Rhabdomyosarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma

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Trial Information

Randomized Study of Vincristine, Actinomycin-D, and Cyclophosphamide (VAC) Versus VAC Alternating With Vincristine, Topotecan and Cyclophosphamide for Patients With Intermediate Risk Rhabdomyosarcoma


OBJECTIVES:

I. Compare the early response rates, failure-free survival, and survival of patients with
intermediate-risk rhabdomyosarcoma treated with surgery, radiotherapy, and vincristine,
dactinomycin, and cyclophosphamide (VAC) vs VAC alternating with vincristine, topotecan, and
cyclophosphamide.

II. Compare the acute and late effects of these two treatment regimens in these patients.

III. Determine the rate of second-look surgery in selected patients with bulk residual tumor
at diagnosis (i.e., Clinical Group III) and the proportion of these that render the patient
tumor free or with microscopic tumor only.

IV. Determine the rate of local failure in selected patients with bulk residual tumors at
diagnosis (i.e., Clinical Group III) who, after second-look resection, have
response-adjusted radiotherapy dose reduction.

V. Determine if preoperative radiotherapy followed by second-look surgery is feasible for
selected patients with bulk residual disease (i.e., Clinical Group III) who respond poorly
to induction chemotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease (embryonal histology, stage II or III, Clinical Group III vs embryonal histology,
Clinical Group IV, less than 10 years of age vs alveolar or undifferentiated sarcoma
histology, stage I, Clinical Group I vs alveolar or undifferentiated sarcoma histology,
stage II or III, Clinical Group II or III). Patients are randomized to 1 of 2 treatment
arms.

Arm I: Patients receive vincristine IV over 5-10 minutes once a week on weeks 0-12, 15,
18-24, 27, 30-36, and 39. Dactinomycin IV is administered over 15-20 minutes once a week on
weeks 0, 3, 6, 9, 12, 21, 24, 27, 30, 33, 36, and 39. Cyclophosphamide IV is administered
over 30-60 minutes once a week on weeks 0, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, and
39. After the initial 12 weeks of chemotherapy, depending on tumor shrinkage, patients may
undergo surgery. After recovery from surgery, patients receive radiotherapy once a day, 5
days a week, during weeks 12-18. For patients receiving radiotherapy during weeks 0-6,
dactinomycin is omitted during weeks 3 and 6 and administered during weeks 15 and 18. For
patients receiving radiotherapy during weeks 12-18, dactinomycin is omitted during weeks 15
and 18. Patients showing an adequate response at week 24 continue chemotherapy during weeks
24-39.

Patients with Clinical Group III tumors of a parameningeal site with documented evidence of
intracranial extension receive radiotherapy within the first 2 weeks of the initiation of
the first course of chemotherapy (day 0).

Patients with Clinical Group II parameningeal tumors and Clinical Group III parameningeal
tumors with base of skull erosion and/or cranial nerve palsy without evidence of
intracranial extension receive radiotherapy on week 12 (day 84) or immediately thereafter.

Patients with Clinical Group IV parameningeal tumors with distant metastases receive
radiotherapy to the primary site on week 12 (day 84). Patients with distant metastases
confined to one site may receive radiotherapy to the metastatic site concurrently with
therapy to the primary site if it began within 2 weeks of the initiation of chemotherapy
(day 0).

Arm II: Patients receive treatment as in arm I, except dactinomycin is replaced with
topotecan IV over 15-30 minutes daily for 5 days during weeks 3, 9, 21, 27, 33, and 39.

All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously beginning 24
hours after completion of each course of chemotherapy and continuing 1 year, until
hematopoietic recovery.

Patients are followed every 1-2 months for 1 year, every 3 months for 1 year, every 6 months
for 1 year, and then annually thereafter.


Inclusion Criteria:



- Histologically proven disease of any of the following types:

- Non metastatic alveolar rhabdomyosarcoma

- Stage I, II, or III; Clinical Group I, II, or III

- Stage II or III, Clinical Group III embryonal rhabdomyosarcoma

- Botryoid

- Spindle cell

- Under 10 years, stage IV, Clinical Group IV embryonal rhabdomyosarcoma

- Botryoid

- Spindle cell

- Undifferentiated sarcoma

- Stage I, II, or III; Clinical Group I, II, or III

- Ectomesenchymoma

- Stage I, II, or III; Clinical Group I, II, or III, with alveolar features

- Under 10 years, Stage IV, Clinical Group IV, with embryonal features

- No more than 6 weeks since initial surgical procedure (e.g., biopsy) giving the
definitive diagnosis

- No parameningeal rhabdomyosarcoma with positive CSF cytology or multiple intracranial
metastases

- Bilirubin no greater than 1.5 mg/dL

- Creatinine normal* for age

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No prior chemotherapy

- Prior steroids allowed

- No prior radiotherapy

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Long-term failure-free survival (FFS) between the two treatment groups

Outcome Time Frame:

Up to 5 years

Safety Issue:

No

Principal Investigator

Carola Arndt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

D9803

NCT ID:

NCT00003958

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Adult Malignant Mesenchymoma
  • Adult Rhabdomyosarcoma
  • Alveolar Childhood Rhabdomyosarcoma
  • Childhood Malignant Mesenchymoma
  • Embryonal Childhood Rhabdomyosarcoma
  • Embryonal-botryoid Childhood Rhabdomyosarcoma
  • Nonmetastatic Childhood Soft Tissue Sarcoma
  • Previously Untreated Childhood Rhabdomyosarcoma
  • Stage I Adult Soft Tissue Sarcoma
  • Stage II Adult Soft Tissue Sarcoma
  • Stage III Adult Soft Tissue Sarcoma
  • Mesenchymoma
  • Rhabdomyosarcoma
  • Rhabdomyosarcoma, Embryonal
  • Sarcoma
  • Liver Neoplasms

Name

Location

Children's Oncology GroupArcadia, California  91006-3776