Phase 3
N=588
Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma
Adult Alveolar Soft-part Sarcoma · Adult Angiosarcoma · Adult Epithelioid Sarcoma · Adult Extraskeletal Chondrosarcoma · Adult Extraskeletal Osteosarcoma
Bottom Line
View on ClinicalTrials.gov: NCT00346164 ↗Enrolled (actual)
588
Serious AEs
1.0%
Results posted
Oct 2017
Primary outcome: Primary: Probability for Event Free Survival. — 0.8984; 0.7647; 0.6079; 0.4873 Probability of EFS at 5 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- doxorubicin hydrochloride (Drug); clinical observation (Other); therapeutic conventional surgery (Procedure); 3-dimensional conformal radiation therapy (Radiation); ifosfamide (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probability for Event Free Survival. |
0.8984; 0.7647; 0.6079; 0.4873 | — |
| SECONDARY Toxicity Rate |
3.06 | — |
| SECONDARY Complete or Partial Response Rate |
33.1 | — |
| SECONDARY Percent Tumor Necrosis |
59.4 | — |
| SECONDARY Event Free Survival Probability Disease Extent |
0.7758; 0.1960 | <0.0001 sig |
| SECONDARY Event Free Survival Probability Histologic Grade |
0.9636; 0.8505; 0.6136 | 0.0049 sig |
| SECONDARY Overall Survival Probability Disease Extent |
0.8752; 0.3153 | <0.0001 sig |
| SECONDARY Overall Survival Probability Extent of Resection of the Primary Tumor |
0.5975; 0.9353; 0.7764 | 0.0096 sig |
| SECONDARY Incidence of Distant Metastasis |
0.00; 5.06; 23.38 | 0.0228 sig |
| SECONDARY Genetic and Gene Expression Profiles |
— | — |
| SECONDARY Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers |
38; 5; 1; 4; 56; 9 | — |
| SECONDARY Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems |
46; 8; 1; 24; 69; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902
- Metastatic or non metastatic disease
- Meets 1 of the following criteria:
- Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following:
- Adipocytic tumor, including liposarcoma of any of the following histology subtypes:
- Dedifferentiated
- Myxoid
- Round cell
- Pleomorphic type
- Mixed-type
- Not otherwise specified (NOS)
- Fibroblastic/myofibroblastic tumors, including any of the following:
- Solitary fibrous tumor
- Hemangiopericytoma
- Low-grade myofibroblastic sarcoma
- Myxoinflammatory fibroblastic sarcoma
- Adult fibrosarcoma*
- Myxofibrosarcoma
- Low-grade fibromyxoid sarcoma or hyalinizing spindle-cell tumor
- Sclerosing epithelioid fibrosarcoma
- So-called fibrohistiocytic tumors, including any of the following:
- Plexiform fibrohistiocytic tumor
- Giant cell tumor of soft tissues
- Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma
- Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells
- Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation
- Smooth muscle tumor (leiomyosarcoma)
- Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma)
- Vascular tumor, including angiosarcoma
- Chondro-osseous tumors of any of the following types:
- Mesenchymal chondrosarcoma
- Extraskeletal osteosarcoma
- Tumors of uncertain differentiation, including any of the following:
- Angiomatoid fibrous histiocytoma
- Ossifying fibromyxoid tumor
- Myoepithelioma/parachordoma
- Synovial sarcoma
- Epithelioid sarcoma
- Alveolar soft-part sarcoma
- Clear cell sarcoma of soft tissue
- Extraskeletal myxoid chondrosarcoma ("chordoid type")
- Malignant mesenchymoma
- Neoplasms with perivascular epithelioid cell differentiation (PEComa)
- Clear cell myomelanocytic tumor
- Intimal sarcoma
- Malignant peripheral nerve sheath tumor
- Dermatofibrosarcoma protuberans meeting both of the following criteria:
- Non metastatic disease
- Tumor must be grossly resected prior to study enrollment
- Embryonal sarcoma of the liver
- Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS)
- Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply:
- Non metastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection
- Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity
- High-grade tumor with metastases
- Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry
- Patients with a tumor recurrence after a gross total resection are not eligible
- Tumors arising in bone are not eligible
- Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes* NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement.
- If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery(prior to study entry for patients assigned to study regimen C)
- Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are 16 years of age)
- Life expectancy ≥ 3 months
- Absolute neutrophil count ≥ 1,000/mm³*
- Platelet count ≥ 100,000/mm³*
- Creatinine clearance or r
Data sourced from ClinicalTrials.gov (NCT00346164). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.