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Trial record 1 of 1 for:    Preoperative Proton Therapy in Soft Tissue Sarcomas of the Extremities and Body Wall (Phase II).
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A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall

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ClinicalTrials.gov Identifier: NCT01819831
Recruitment Status : Recruiting
First Posted : March 28, 2013
Last Update Posted : March 4, 2022
Information provided by (Responsible Party):
Gary Yang, MD, Loma Linda University

Brief Summary:

When treated with surgery alone, many soft-tissue sarcomas have a high chance of coming back. Radiation therapy is frequently used in addition to surgery to reduce the chances of the sarcoma coming back. However, radiation can have long-term side effects on the normal tissues surrounding the tumor, leading to problems such as swelling, scarring, and joint stiffness.

Recently, there have been advances in the way that radiation therapy can be given. Proton radiation therapy is one of those advances. With proton radiation, it is possible to give radiation over a smaller area surrounding the tumor, resulting in less radiation to the surrounding normal tissues.

The purpose of this study is to determine whether proton radiation decreases the long-term side effects of radiation on normal tissues and if smaller proton radiation fields reduce local recurrence compared to the larger radiation fields that have been used in prior studies.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Radiation: proton radiation Procedure: surgery (wide local excision; limb preservation surgery) Not Applicable

Detailed 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 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall
Actual Study Start Date : February 27, 2013
Estimated Primary Completion Date : March 2029
Estimated Study Completion Date : March 2034

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Preoperative proton radiation
Patients will receive 50 Gray equivalents (GyE) in 25 fractions with proton therapy, followed by surgery 4-8 weeks after completion of radiation.
Radiation: proton radiation
proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions)
Other Names:
  • Proton radiotherapy
  • Proton treatment

Procedure: surgery (wide local excision; limb preservation surgery)
In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
Other Names:
  • wide local excision
  • limb preservation surgery

Primary Outcome Measures :
  1. Late radiation toxicities (>grade 2 lymphedema, subcutaneous fibrosis, and joint stiffness) [ Time Frame: at 2 years from the start of radiation treatment ]

Secondary Outcome Measures :
  1. Grade 3-5 adverse events (CTCAE, v4.0) [ Time Frame: 6 months ]
  2. Composite patterns of failure, including local failure (in-field, marginal, out-of-field), regional failure, distant failure, and death without disease progression [ Time Frame: 6 months ]
  3. Composite measures of local failure, including local-regional failure, distant failure, distant-disease-free survival, disease-free survival, overall survival rates, and second primary tumor [ Time Frame: 6 months ]
  4. Wound complication rates [ Time Frame: 6 months ]
    Infection, dehiscence

  5. Degree of late radiation morbidity at 2 years with quality of life assessment (FACT-G) [ Time Frame: at 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • Evaluation by surgeon, with documentation that the tumor is resectable
  • ECOG performance status 0-1
  • For females of childbearing potential, a serum pregnancy test within 4 weeks prior to registration
  • Patient must practice adequate contraception
  • Adequate bone marrow function

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819831

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Contact: Sandi or Miriam RN Coordinators, S Teichman RN or M Hernandez, RN 909-558-4000 ext 55240 / 88231 scteichm@llu.edu; mvhernandez@llu.edu
Contact: Gary Yang, MD 909-558-4000 ext 15689 gyang@llu.edu

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United States, California
Loma Linda University Medical Center / James M. Slater Proton Treatment Center Recruiting
Loma Linda, California, United States, 92354
Principal Investigator: Gary Y Yang, MD         
Sponsors and Collaborators
Loma Linda University
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Principal Investigator: Gary Yang, MD gyang@llu.edu
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Responsible Party: Gary Yang, MD, Principal Investigator, Loma Linda University
ClinicalTrials.gov Identifier: NCT01819831    
Other Study ID Numbers: 5120263
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Gary Yang, MD, Loma Linda University:
extremity soft tissue sarcoma
proton radiation
preoperative radiation
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type