A Phase II Trial of Preoperative Proton Therapy in Soft-tissue Sarcomas of the Extremities and Body Wall

NCT01819831 | Completed Results FDA Device

• 1 other identifier: 5120263
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Keywords

extremity soft tissue sarcoma; proton radiation; preoperative radiation

Outcome Measures

Primary Outcomes (1)

• Late Radiation Toxicities at 2 Years From the Start of Radiation Treatment

  To report the number of participants with late radiation morbidity Late subcutaneous fibrosis and joint stiffness are assessed using the European Organization for Research and Treatment of Cancer/Radiation Therapy Oncology Group (EORTC/RTOG) late toxicity scoring criteria below: Subcutaneous tissue: Grade 1(slight fibrosis; subcutaneous fat loss), Grade 2(moderate fibrosis: slight field contracture), Grade 3(severe fibrosis; field contracture \>10%), Grade 4(necrosis), Grade 0 (none) Joint stiffness: Grade 1(mild stiffness; slight range of motion loss), Grade 2(Moderate stiffness, pain, range of motion loss), Grade 3(Severe stiffness, pain, range of motion loss), Grade 4(necrosis; complete fixation), Grade 0 (none) Lymphedema is measured according to the criteria of Stern: Score 0(none), Score 1(Mild but definite swelling), Score 2(Moderate), Score 3(Severe, considerable swelling), Grade 4(Very severe (skin shiny \& tight)

  at 2 years from the start of radiation treatment

Secondary Outcomes (5)

• Grade 3-5 Adverse Events at 6 Months From the Start of Radiation Treatment.

  6 months

• Patterns of Failure at 6 Months From the Start of Radiation Treatment

  6 months

• Patterns of Failure at 6 Months

  6 months

• Wound Complication Rates Infection, Dehiscence at 6 Months From the Start of Radiation Treatment.

  6 months

• Report of Late Radiation Morbidity at 2 Years

  at 2 years

Study Arms (1)

Preoperative proton radiation

EXPERIMENTAL

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; Procedure: surgery (wide local excision; limb preservation surgery)

Interventions

proton radiation 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)

Also known as: Proton radiotherapy, Proton treatment

Preoperative proton radiation

surgery (wide local excision; limb preservation surgery) PROCEDURE

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.

Also known as: wide local excision, limb preservation surgery

Preoperative proton radiation

Eligibility Criteria

• Age: 18 Years - 98 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center / James M. Slater Proton Treatment Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Proton Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Gary Yang, Professor, Chair of Radiation Medicine
• Organization: Loma Linda University Health

gyang@llu.edu

909 558 4444

Study Officials

• Gary Yang, MD

  gyang@llu.edu

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 28, 2013
• Study Start: February 27, 2013
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: August 23, 2023
• Results First Posted: August 23, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)