Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

Sponsor

Abramson Cancer Center of the University of Pennsylvania (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01034566

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Detailed Description

Detailed DescriptionPRIMARY OBJECTIVES:

To determine the feasibility and toxicity of proton radiotherapy for retroperitoneal sarcomas.
To determine the maximum safe proton radiotherapy dose for retroperitoneal sarcomas.
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)

SECONDARY OBJECTIVES:

To assess the clinical effectiveness of proton radiotherapy for retroperitoneal sarcoma.
To determine the long-term toxicity of proton radiotherapy to the abdomen and pelvis region.
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).

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Proton radiation for retroperitoneal sarcomaProton radiation for retroperitoneal sarcoma

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Proton Radiotherapy for Retroperitoneal Sarcoma

Actual Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Acute toxicity as assessed by NCI CTC Version 3.0 [Within 60 days of completion of radiotherapy]

Secondary Outcome Measures

Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system [After 60 days of therapy]
Clinical efficacy [One year]
Local recurrence-free survival, distant metastasis-free survival, and overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

Abramson Cancer Center of the University of Pennsylvania

Investigators

Principal Investigator: Curtiland Deville, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abramson Cancer Center of the University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01034566

Other Study ID Numbers:

UPCC 04509

First Posted:

Dec 17, 2009

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Additional relevant MeSH terms:

Sarcoma

Study Results

No Results Posted as of Jun 10, 2021