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A Pilot Study for Soft Tissue Sarcoma


N/A
N/A
21 Years
Open (Enrolling)
Both
Ovarian Cancer, Sarcoma

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Trial Information

A Pilot Study for Soft Tissue Sarcoma


OBJECTIVES:

- To evaluate the efficacy, in terms of clinical response, pathologic response, and
long-term disease-free survival, of a multidrug chemotherapy regimen patients with
spindle cell or small round cell sarcoma.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive vincristine IV, cyclophosphamide IV over 1 hour and
doxorubicin hydrochloride IV over 48 hours on day 1 in week 0. Patients continue to
receive vincristine IV once weekly in weeks 1 and 2. Patients also receive etoposide IV
over 1 hour and ifosfamide IV over 1 hour for 5 days in week 3. Treatment repeats every
6 weeks for 2 courses.

- Local control: After completing induction therapy, patients are reevaluated for local
control therapy. Some patients may undergo surgery and/or radiotherapy (e.g.,
brachytherapy, intraoperative radiotherapy, external beam therapy). Patients who
undergo surgery begin consolidation therapy 2 weeks after completing surgery. Some
patients undergo radiotherapy 5 days a week for 5½ weeks beginning at week 12 and/or
after surgery (weeks 15-16).

- Consolidation therapy: Patients receive vincristine IV, doxorubicin hydrochloride IV
over 1 hour, and cyclophosphamide IV over 1 hour once in weeks 12 and 18*. Patients
also receive etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week
15. Patients are reevaluated for local control therapy at week 21.

NOTE: *Patients undergoing radiotherapy do not receive doxorubicin hydrochloride in week 18
or week 24.

- Maintenance therapy: Patient receive vincristine IV, doxorubicin hydrochloride IV over
1 hour, and cyclophosphamide IV over 1 hour once in week 24. Patients also receive
etoposide IV over 1 hour and ifosfamide IV over 1 hour for 5 days in week 21. Treatment
repeats every 6 weeks for 3 courses. In week 36, patients receive vincristine,
doxorubicin hydrochloride and cyclophosphamide OR etoposide and ifosfamide as before.
In week 39 patients receive etoposide and ifosfamide as before.

After completion of treatment, patients are followed periodically for at least 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of any of the following:

- High-grade nonmetastatic, nonrhabdomyosarcomatous soft tissue sarcomas
(excluding undifferentiated sarcoma and Ewing sarcoma)

- Small round cell sarcomas (excluding primitive neuroectodermal tumors of soft
tissue) (closed to accrual)

- Undifferentiated sarcomas (closed to accrual)

- Rhabdomyosarcomas (excluding non-parameningeal head tumors, vaginal or stage I
paratesticular) (closed to accrual)

- All alveolar rhabdomyosarcomas (closed to accrual)

- No evidence distant metastatic disease (i.e., lung, bone, bone marrow)

- Local or regional nodal disease allowed

- No spindle cell tumors of bone

- Primary lesions do not have to be resectable

PATIENT CHARACTERISTICS:

- Creatinine ≤1.5 mg/dL OR creatinine clearance > 60 mL/min/

- AST/ALT < 2 times upper limit of normal (ULN)

- Total bilirubin < 2 times ULN

- LVEF ≥ 45%

- No prior history of cancer

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- Patients who have undergone radiation therapy after initial surgery are eligible but
must have evaluation for metastatic disease within 2 weeks of starting chemotherapy

- No prior chemotherapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Efficacy in terms of long-term disease-free survival

Safety Issue:

No

Principal Investigator

Carola A. S. Arndt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000582271

NCT ID:

NCT00662233

Start Date:

October 1991

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Sarcoma
  • alveolar childhood rhabdomyosarcoma
  • previously treated childhood rhabdomyosarcoma
  • previously untreated childhood rhabdomyosarcoma
  • recurrent childhood rhabdomyosarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • recurrent childhood soft tissue sarcoma
  • childhood desmoplastic small round cell tumor
  • ovarian sarcoma
  • stage II uterine sarcoma
  • stage III uterine sarcoma
  • embryonal childhood rhabdomyosarcoma
  • Ovarian Neoplasms
  • Sarcoma

Name

Location

Mayo ClinicRochester, Minnesota  55905