Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 588
- 试验地点
- 187
- 主要终点
- Probability for Event Free Survival.
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
I. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS).
II. Assess event-free and overall survival of patients treated with these regimens.
III. Assess the pattern of treatment failure in these patients.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
- 另有 36 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm A: No adjuvant treatment
Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).
干预措施: clinical observation (Other)
Arm A: No adjuvant treatment
Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).
干预措施: therapeutic conventional surgery (Procedure)
Arm B: Low risk; adjuvant radiotherapy
Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
干预措施: clinical observation (Other)
Arm B: Low risk; adjuvant radiotherapy
Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
干预措施: therapeutic conventional surgery (Procedure)
Arm B: Low risk; adjuvant radiotherapy
Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
干预措施: doxorubicin hydrochloride (Drug)
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
干预措施: clinical observation (Other)
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm C: Intermediate & High risk; adjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.
干预措施: ifosfamide (Drug)
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
干预措施: doxorubicin hydrochloride (Drug)
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
干预措施: clinical observation (Other)
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
干预措施: therapeutic conventional surgery (Procedure)
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy
High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.
干预措施: ifosfamide (Drug)
结局指标
主要结局
Probability for Event Free Survival.
时间窗: 5 years
Probability of no relapse, secondary malignancy or death after 5 years since enrollment.
次要结局
- Overall Survival Probability Extent of Resection of the Primary Tumor(5 years)
- Complete or Partial Response Rate(13 weeks)
- Toxicity Rate(13 weeks)
- Event Free Survival Probability Histologic Grade(5 years)
- Incidence of Distant Metastasis(Up to 10 years)
- Overall Survival Probability Disease Extent(5 years)
- Genetic and Gene Expression Profiles(At diagnosis)
- Event Free Survival Probability Disease Extent(5 years)
- 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(At diagnosis)
- Percent Tumor Necrosis(13 weeks)
- Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers(At Diagnosis)