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Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01034566
Recruitment Status : Withdrawn (Failure to accrue)
First Posted : December 17, 2009
Last Update Posted : April 17, 2019
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with retroperitoneal sarcoma. PURPOSE: This phase I trial is studying the side effects and and best dose of proton beam radiation therapy in treating patients with retroperitoneal sarcoma.

Condition or disease Intervention/treatment Phase
Adult Soft Tissue Sarcoma Radiation: Proton Beam Radiation Therapy Not Applicable

Detailed Description:

Detailed DescriptionPRIMARY OBJECTIVES:

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

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 region.

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Proton radiation for retroperitoneal sarcoma
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proton Radiotherapy for Retroperitoneal Sarcoma
Actual Study Start Date : November 2009
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Arm I
Patients undergo proton beam radiotherapy 5 days a week for 6 (preoperative patients) or 8 (post-operative patients) weeks in the absence of disease progression or unacceptable toxicity.
Radiation: Proton Beam Radiation Therapy

Primary Outcome Measures :
  1. Feasibility [ Time Frame: One year ]
    Feasibility of pre-operative and post-operative proton radiation therapy

  2. Acute toxicity as assessed by NCI CTC Version 3.0 [ Time Frame: Within 60 days of completion of radiotherapy ]

Secondary Outcome Measures :
  1. Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system [ Time Frame: After 60 days of therapy ]
  2. Clinical efficacy [ Time Frame: One year ]
    Local recurrence-free survival, distant metastasis-free survival, and overall survival

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT01034566

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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
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Principal Investigator: Curtiland Deville, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania Identifier: NCT01034566    
Other Study ID Numbers: UPCC 04509
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: July 2016
Additional relevant MeSH terms:
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Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type