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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Soft Tissue Sarcoma

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Trial Information

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


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:



- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Late radiation toxicities (>grade 2 lymphedema, subcutaneous fibrosis, and joint stiffness)

Outcome Time Frame:

at 2 years from the start of radiation treatment

Safety Issue:

No

Principal Investigator

Gary Yang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Loma Linda University Medical Center

Authority:

United States: Institutional Review Board

Study ID:

5120263

NCT ID:

NCT01819831

Start Date:

March 2013

Completion Date:

March 2016

Related Keywords:

  • Soft Tissue Sarcoma
  • extremity soft tissue sarcoma
  • proton radiation
  • preoperative radiation
  • Sarcoma

Name

Location

Loma Linda University Medical Center / James M. Slater Proton Treatment CenterLoma Linda, California  92354