Recruitment

Recruitment Status
Recruiting

Inclusion Criteria

Evaluation by surgeon, with documentation that the tumor is resectable
Patient must practice adequate contraception
For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
...
Evaluation by surgeon, with documentation that the tumor is resectable
Patient must practice adequate contraception
For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
Histologically proven primary soft tissue sarcoma of the upper extremity (including shoulder), lower extremity (including hip) or body trunk (excluding retroperitoneum).
No clinical evidence of distant metastatic disease
Adequate bone marrow function
ECOG performance status 0-1

Exclusion Criteria

Clinical evidence of regional lymph node or distant metastatic disease
Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma
Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot
...
Clinical evidence of regional lymph node or distant metastatic disease
Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma
Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to used medically acceptable forms of contraception
Histopathology demonstrating rhabdomyosarcoma, extraosseous primitive neuroectodermal tumor (PNET), soft tissue Ewing's sarcoma, osteosarcoma, Kaposi's sarcoma, angiosarcoma, aggressive fibromatosis, dermatofibrosarcoma protuberans or chondrosarcoma
Prior invasive malignancy (except non-melanomatous skin cancer or early stage prostate cancer) unless disease free for a minimum of 3 years

Summary

Conditions
Soft Tissue Sarcoma
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 98 years
Gender
Both males and females

Description

Data support preoperative radiotherapy as one of the standard options in the management of large or high-grade extremity soft tissue sarcomas (STS). The advantages of preoperative radiotherapy are lower doses and smaller radiation volumes; these may be used to effect improvement of long-term side ef...

Data support preoperative radiotherapy as one of the standard options in the management of large or high-grade extremity soft tissue sarcomas (STS). The advantages of preoperative radiotherapy are lower doses and smaller radiation volumes; these may be used to effect improvement of long-term side effects and extremity function. Another potential advantage is assisting surgery through tumor shrinkage and reduction of tumor cell seeding. The disadvantage of preoperative radiation is the higher likelihood of postoperative wound complications, but in a prospective phase III trial these complications were found to be generally temporary and without significant effect on long term function. Combined conservative surgery and radiotherapy has shown to achieve excellent local control in sarcoma patients following margin-negative surgery, but late radiation morbidity and reduced quality of life may result from adjuvant radiation. The dosimetric advantage of proton radiotherapy may translate into reduced acute and late effects due to improved normal-tissue sparing in the treatment of extremity and truncal STS. However, these potential advantages need to be validated in clinical trials. The investigators propose a phase II study to evaluate the effect of preoperative proton radiotherapy on the reduction of late radiation morbidity, patterns of failure, and impact of late radiation morbidity on general quality of life (QOL).

Inclusion Criteria

Evaluation by surgeon, with documentation that the tumor is resectable
Patient must practice adequate contraception
For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
...
Evaluation by surgeon, with documentation that the tumor is resectable
Patient must practice adequate contraception
For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
Histologically proven primary soft tissue sarcoma of the upper extremity (including shoulder), lower extremity (including hip) or body trunk (excluding retroperitoneum).
No clinical evidence of distant metastatic disease
Adequate bone marrow function
ECOG performance status 0-1

Exclusion Criteria

Clinical evidence of regional lymph node or distant metastatic disease
Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma
Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot
...
Clinical evidence of regional lymph node or distant metastatic disease
Prior radiotherapy to the potential target anatomic region would result in overlap of radiation fields for current sarcoma
Patients with sarcoma of the head, neck, intra-abdominal or retroperitoneal region, hand or foot
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to used medically acceptable forms of contraception
Histopathology demonstrating rhabdomyosarcoma, extraosseous primitive neuroectodermal tumor (PNET), soft tissue Ewing's sarcoma, osteosarcoma, Kaposi's sarcoma, angiosarcoma, aggressive fibromatosis, dermatofibrosarcoma protuberans or chondrosarcoma
Prior invasive malignancy (except non-melanomatous skin cancer or early stage prostate cancer) unless disease free for a minimum of 3 years

Tracking Information

NCT #
NCT01819831
Collaborators
Not Provided
Investigators
  • Principal Investigator: Gary Yang, MD gyang@llu.edu
  • Gary Yang, MD gyang@llu.edu