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Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02634710
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Meena Bedi, Medical College of Wisconsin

Brief Summary:
This is a nonrandomized Phase II pilot protocol to determine the feasibility, toxicity and disease control (local control, overall and progression-free survival) using hypofractionated preoperative radiation therapy in patients with primary localized soft tissue sarcomas (STS).

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Radiation: Hypofractionated Radiation Therapy Not Applicable

Detailed Description:

BACKGROUND OVERVIEW: Hypofractionation has several potential advantages over conventional radiation. First, the biological equivalent dose to the tumor is higher with hypofractionation than it is with conventional radiation. In between radiation treatments there is repair of the radiation damaged cancer cells (on a cell survival curve this region of repair is referred to as the "shoulder" of the curve). Some cell lines are better at repair than others. Sarcoma is often referred to as a "radioresistant" tumor, which means that sarcoma cell lines have a larger capacity for radiation repair than do other cell lines. A treatment that can deliver a high dose in fewer fractions can potentially overcome some of this repair. There is a concept in radiation known as "biologically equivalent dose" (BED) which states that a higher dose per fraction results in more tumor kill than a lower dose per fraction. For example, radiation delivered to a total of 60 Gy in three 20 Gy fractions is the equivalent of 150 Gy in 2 Gy fractions.

BACKGROUND RATIONALE: It is important to conduct this study because hypofractionation not only decreases treatment package time and cost of care, but it also potentially improves patient convenience and quality of life and could impact radiologic and pathologic variables in a positive way by leading to more tumor cell kill. This could potentially change the paradigm of the current management of STS of the extremity and chest-wall.

HYPOTHESIS: Preoperative hypofractionated radiation therapy for localized soft tissue sarcomas (STS) will result in local control and toxicity similar to conventional fractionation with less cost, more patient convenience and decreased overall treatment time.

TREATMENT: Image-guided radiation therapy is mandatory. PREOPERATIVE: (1) Either 3D conformal radiotherapy or intensity modulated radiation therapy (IMRT). (2) A prescription dose of 35 Gy in 5 fractions given every other day with at least 48 hours in between each fraction will be prescribed to cover 95% of the planning target volume. TREATMENT SCHEDULE: Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Evaluating Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall
Study Start Date : February 23, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hypofractionated Radiation Therapy
Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given every other day. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
Radiation: Hypofractionated Radiation Therapy
Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.




Primary Outcome Measures :
  1. Local disease control assessed by physical examination [ Time Frame: 2 Years ]
    This measure will capture the number of subjects experiencing a recurrence of the primary lesion assessed by physical examination.

  2. Local disease control assessed by Magnetic Resonance Imaging (MRI) [ Time Frame: 2 years ]
    This measure is the number of subjects experiencing a recurrence of the primary lesion as assessed by MRI.


Secondary Outcome Measures :
  1. Number of Participants Experiencing a Serious Adverse Event [ Time Frame: Baseline (typically 2 to 4 weeks prior to surgery) and 4, 8, 12, 16, 20, and 24 months after surgery ]
    Adverse events will be assessed at specific times using the Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.

  2. Musculoskeletal Tumor Rating Scale (MSTS) Score [ Time Frame: Baseline (typically 2 to 4 weeks prior to surgery) and 4, 8, 12, 16, 20, and 24 months after surgery ]
    Toxicity will be assessed at specific times the Musculoskeletal Tumor Rating Scale. The MSTS evaluates: pain, function, emotional acceptance, hand positioning, dexterity and lifting ability, using a six-item Likert scale ranging from 0 (worst condition) to 5 (least condition). Subscores are added for a total score.

  3. Quality of Life Score [ Time Frame: Baseline (typically 2 to 4 weeks prior to surgery) and 4, 8, 12, 16, 20, and 24 months after surgery ]
    Quality of life will be assessed via the Functional Assessment of Cancer Therapy - General (FACT-G) forms and given at the specified time points above. The FACT-G questionnaire is a five-point, Likert scale with responses ranging from 0 (not at all) to 4 (very much). Subscale scores are added to achieve the total score.

  4. Disease-free survival [ Time Frame: 2 Years ]
    Disease‐free survival will measure the time in months from initiation of radiation therapy until documented recurrence of disease. Patients who are disease‐free and alive at the time of analysis will be censored at the time of their last follow‐up. Patients will be assessed for disease‐free survival at 2 years.

  5. Overall survival [ Time Frame: 2 Years ]
    Overall survival will measure the time from initiation of radiation therapy until documented death from any cause. Patients who are alive at the time of analysis will be censored at the time of their last follow‐up. Patients will be assessed for overall survival at 2 years.

  6. Radiologic changes due to hypofractionated radiation. [ Time Frame: 4 weeks after radiation therapy ]
    This measure will assess the presence or absence of enhancement of T2 imaging.

  7. Pathologic changes due to hypofractionated radiation. [ Time Frame: 2 weeks after surgery ]
    This measure will capture the fibrosis present in tissue specimens as a percent.



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
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • Core needle biopsy obtained
  • Pathologic confirmation of primary soft tissue sarcoma of the upper or lower extremity or chest-wall.
  • Stage I-III Soft Tissue Sarcoma of the extremity without evidence of metastatic disease
  • Medically operable
  • No prior radiotherapy to primary site or adjacent site that results in overlapping radiation fields.
  • MRI obtained of the affected extremity or chest-wall
  • CT chest acquired to assess distant disease
  • Karnofsky Performance Status (KPS) 60 or above
  • Informed consent obtained prior to study entry

Exclusion Criteria:

  • Patients who have metastatic disease
  • Pregnant women
  • Women of childbearing potential and male participants must practice adequate contraception.
  • Disease pathology other than sarcoma subtypes
  • Patients with a history of metastatic disease from a primary other than sarcoma
  • Patients who cannot undergo MRI as part of pre-treatment or treatment planning process
  • STS of non-extremity or chest-wall regions
  • Tumor size ≥ 20 cm maximal dimension

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 ClinicalTrials.gov identifier (NCT number): NCT02634710


Contacts
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Contact: Medical College of Wisconsin Clinical Cancer Center 414-805-8900 cccto@mcw.edu
Contact: Meena Bedi, MD 414-805-4400 mbedi@mcw.ed

Locations
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United States, Wisconsin
Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Meena Bedi, MD         
Contact: Cancer Center Clinical Trials    1-866-680-0505 ext 8900    cccto@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Meena Bedi, MD Medical College of Wisconsin

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Responsible Party: Meena Bedi, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02634710    
Other Study ID Numbers: 25722
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Meena Bedi, Medical College of Wisconsin:
soft tissue sarcoma
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms