Proton Beam Radiation Therapy in Treating Patients With Retroperitoneal Sarcoma

Adult Soft Tissue Sarcoma Clinical Trial

Official title:

Proton Radiotherapy for Retroperitoneal Sarcoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01034566
• Other study ID #: UPCC 04509
• Status: Withdrawn
• Phase: N/A
• Start date: November 2009
• Est. completion date: January 2013

Study information

• Verified date: June 2021
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Soft Tissue Sarcoma
• Sarcoma

Intervention

Radiation:
• Proton Beam Radiation Therapy

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity as assessed by NCI CTC Version 3.0		Within 60 days of completion of radiotherapy
Secondary	Late toxicity as assessed by the RTOG/EORTC late morbidity scoring system		After 60 days of therapy
Secondary	Clinical efficacy	Local recurrence-free survival, distant metastasis-free survival, and overall survival	One year