Type(s) of Cancer
Sarcoma
Sarcoma
Study Phase
Phase 3
Study Completion Date
2014-09-05
2014-09-05
NCT00346164Uploaded 08-12-2021
Access via NCI by Request
PDS UID: nci-data-482
Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age
Provider Information
Provider Data DescriptionDataset NCT00346164 -D1 is for recreating the results of the manuscript, which includes demographic and clinical characteristics, and survival outcomes. Each row corresponds with data from a single, unique patient.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsAdult 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
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
Intervention TypeDrug: doxorubicin hydrochloride
Other: clinical observation
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Drug: ifosfamide
Other: clinical observation
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
Drug: ifosfamide
Drug(s)Drug: doxorubicin hydrochloride
Drug: ifosfamide
Drug: ifosfamide
Total Enrolled588
RandomizationNon Randomized
Blinding MethodNone
Arms InterventionArm A: No adjuvant treatment - Experimental
Arm B: Low risk; adjuvant radiotherapy - Experimental
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy - Experimental
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy - Experimental
Arm B: Low risk; adjuvant radiotherapy - Experimental
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy - Experimental
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy - Experimental
Secondary IDNCI-2009-00426
PubMed (PMID)34623899
33548339
31786124
30954717
28391003
33548339
31786124
30954717
28391003
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
New Zealand
Puerto Rico
Australia
Canada
New Zealand
Puerto Rico
Age Range29 Years and younger (CHILD, ADULT)
Files: NCT00346164-D1
Data DictionaryNCT00346164-D1-Data-Dictionary_1.pdf
DATANCT00346164-D1-Dataset_1.csv
OTHERREADME.pdf
