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Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

Primary Purpose

Adult Soft Tissue Sarcoma

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Proton Beam Radiation Therapy

About this trial

This is an interventional treatment trial for Adult Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Acute toxicity as assessed by NCI CTC Version 3.0

Secondary Outcome Measures

Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system

Clinical efficacy

Local recurrence-free survival, distant metastasis-free survival, and overall survival

Full Information

NCT ID

NCT01034566

First Posted

December 4, 2009

Last Updated

June 8, 2021

Sponsor

Abramson Cancer Center at Penn Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01034566

Brief Title

Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

Official Title

Proton Radiotherapy for Retroperitoneal Sarcoma

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Failure to accrue

Study Start Date

November 2009 (Actual)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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) SECONDARY OBJECTIVES: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Soft Tissue Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Proton radiation for retroperitoneal sarcoma

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Proton Beam Radiation Therapy

Primary Outcome Measure Information:

Title

Acute toxicity as assessed by NCI CTC Version 3.0

Time Frame

Within 60 days of completion of radiotherapy

Secondary Outcome Measure Information:

Title

Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system

Time Frame

After 60 days of therapy

Title

Clinical efficacy

Description

Local recurrence-free survival, distant metastasis-free survival, and overall survival

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Curtiland Deville, MD

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Abramson Cancer Center of the University of Pennsylvania

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

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Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

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