Stereotactic Radiosurgery for Soft Tissue Sarcoma

NCT02706171 | Withdrawn

• 1 other identifier: 15-073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study is evaluating treatment with CyberKnife for soft tissue sarcomas.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1-2 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 year

• Progression Free Survival

  5 years

Secondary Outcomes (2)

• change in tumor burden by RECIST 1.1 response assessment

  1-2 months, 4 months

• overall survival

  6 months, 1 year, 5 years

Study Arms (3)

A: pre-operative

EXPERIMENTAL

Radiation- CyberKnife: 35-40 Gy over 5 fractions Surgery: Surgical resection of sarcoma

Radiation: CyberKnife

B: Post-operative

EXPERIMENTAL

Radiation- CyberKnife: 40 Gy over 5 fractions

Radiation: CyberKnife

C: Non-resectable

EXPERIMENTAL

Radiation- CyberKnife: 50 Gy over 5 fractions

Radiation: CyberKnife

Interventions

CyberKnife RADIATION

Also known as: CK

A: pre-operative; B: Post-operative; C: Non-resectable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cohorts:
• Age \> 18
• Patients of child-bearing age must agree to contraception until radiosurgery has been completed.
• Note that patients with metastatic disease are eligible for protocol
• Cohort 1: Soft tissue sarcoma (of any histology subtype) in patients that are -planned to have pre-operative radiation followed by surgical resection
• Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip)
• Patient performance status and co-morbid conditions to allow for surgical resection
• Cohort 2: soft tissue sarcoma (of any histologic subtype) post-resection with no further plans for additional surgery.
• Patients must have high risk feature requiring post-operative radiation which can include Large tumor (\> 5 cm), High grade, Previous unplanned, non, oncologic surgery, Close margins
• Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip)
• Cohort 3: soft tissue sarcoma (of any histologic subtype) that is not amenable to surgical resection for any reason
• Anatomical site to include upper extremity (including shoulder) and lower extremity (including hip and pelvis)
• Patients cannot have planned surgical resection
• Note that retroperitoneal sarcomas are not eligible

You may not qualify if:

• Tumors that do not fit criteria for any of the above cohorts

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

MD Anderson Cancer Center at Cooper

Camden, New Jersey, 08103, United States

Location

Related Publications (1)

• Kubicek GJ, Kim TW, Gutowski CJ, Kaden M, Eastwick G, Khrizman P, Xu Q, Lackman R. Preoperative Stereotactic Body Radiation Therapy for Soft-Tissue Sarcoma: Results of Phase 2 Study. Adv Radiat Oncol. 2021 Nov 20;7(2):100855. doi: 10.1016/j.adro.2021.100855. eCollection 2022 Mar-Apr.

  PMID: 35387414 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: March 11, 2016
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

US (1)