Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Summary

This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Conditions

• Adult Alveolar Soft-part Sarcoma
• Adult Angiosarcoma
• Adult Epithelioid Sarcoma
• Adult Extraskeletal Chondrosarcoma
• Adult Extraskeletal Osteosarcoma
• Adult Fibrosarcoma
• Adult Leiomyosarcoma
• Adult Liposarcoma
• Adult Malignant Fibrous Histiocytoma
• Adult Malignant Hemangiopericytoma
• Adult Malignant Mesenchymoma
• Adult Neurofibrosarcoma
• Adult Synovial Sarcoma
• Childhood Alveolar Soft-part Sarcoma
• Childhood Angiosarcoma
• Childhood Epithelioid Sarcoma
• Childhood Fibrosarcoma
• Childhood Leiomyosarcoma
• Childhood Liposarcoma
• Childhood Malignant Mesenchymoma
• Childhood Neurofibrosarcoma
• Childhood Synovial Sarcoma
• Dermatofibrosarcoma Protuberans
• Metastatic Childhood Soft Tissue Sarcoma
• Nonmetastatic Childhood Soft Tissue Sarcoma
• Stage I Adult Soft Tissue Sarcoma
• Stage II Adult Soft Tissue Sarcoma
• Stage III Adult Soft Tissue Sarcoma
• Stage IV Adult Soft Tissue Sarcoma

Interventions

DRUG

doxorubicin hydrochloride

Given IV

OTHER

clinical observation

Patients undergo observation

PROCEDURE

therapeutic conventional surgery

Patients undergo surgery

RADIATION

3-dimensional conformal radiation therapy

Patients undergo radiotherapy

DRUG

ifosfamide

Given IV

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Children's Oncology Group

  lead NETWORK

Principal Investigators

• Sheri Spunt, MD · Children's Oncology Group

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

29 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-02-05

Primary Completion

2014-09-05

Completion

2022-03-31

Countries

• United States
• Australia
• Canada
• New Zealand
• Puerto Rico

Study Locations