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Proton Radiotherapy for Retroperitoneal Sarcoma

Phase 1
18 Years
Not Enrolling
Adult Soft Tissue Sarcoma

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Trial Information

Proton Radiotherapy for Retroperitoneal Sarcoma

Detailed DescriptionPRIMARY OBJECTIVES:

I. To determine the feasibility and toxicity of proton radiotherapy for retroperitoneal

II. To determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas.

III. To determine the maximally tolerated dose of proton radiotherapy for patients with
potentially resectable retroperitoneal sarcoma. (Pre-operative cohort) IV. To assess acute
side effects from irradiation using proton beam therapy and dose/volume constraints that are
derived from conventional radiotherapy. (Postoperative cohort)


I. To assess the clinical effectiveness of proton radiotherapy for retroperitoneal sarcoma.

II. To determine the long-term toxicity of proton radiotherapy to the abdomen and pelvis

III. To monitor for effects of proton treatment on tumor and normal tissues using
radiographic imaging (both cohorts) or ex-vivo analysis of tissue samples (preoperative
cohort only).

Inclusion Criteria:

- Patients with a histologic diagnosis of sarcoma in the
peritoneum/retroperitoneum/pelvis are eligible for this study

- Patients must have either radiographic(pre-operative) or pathologic (post-operative)
evidence of disease limited the peritoneum/retroperitoneum/pelvis without evidence of
peritoneal sarcomatosis

- For pre-operative cases, the patient must be considered operable/resectable as judged
by the attending surgeon (this is determined by an extensive radiographic and medical
evaluation that includes but is not limited to: CT Chest and Abdomen with contrast,
MRI/CT Brain and Medical/Cardiac Clearance)

- Patients should have an EGOC status of 0-2

- Patients must sign a document that indicates that they are aware of the investigative
nature of the treatment of this protocol, and the potential benefits and risks
(patients unwilling or unable to sign informed consent are excluded from the study)

- Women of child-bearing potential as long as she agrees to use a recognized method of
birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.);
hysterectomy or menopause must be clinically documented

Exclusion Criteria:

- Prior or simultaneous malignancies within the past two years (other than cutaneous
squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)

- Pregnant women, women planning to become pregnant and women that are nursing

- Patients who experience surgical complications that prevent radiation from starting
for 5 months or more, unless there is evidence of gross residual disease

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:



United States: Institutional Review Board

Study ID:

UPCC 04509



Start Date:

November 2009

Completion Date:

November 2012

Related Keywords:

  • Adult Soft Tissue Sarcoma
  • Sarcoma



Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283