search
Back to results

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

Primary Purpose

Adult Soft Tissue Sarcoma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Preoperative intensity modulated radiation therapy
Postoperative intensity modulated radiation therapy
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Soft Tissue Sarcoma focused on measuring Soft tissue sarcoma, Extremity, Preoperative radiotherapy, Postoperative radiotherapy

Eligibility Criteria

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

Inclusion Criteria:

  1. Histologically proven soft tissue sarcoma of the extremity or trunk following review by local reference pathologist.
  2. Deemed appropriate for preoperative or postoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist.
  3. Lesion is primary or locally recurrent. Patient may have undergone excisional biopsy with positive margins at a referring hospital and are eligible following discussion among the surgical oncologists and radiation oncologists that IMRT is an acceptable treatment for that case.
  4. Eastern Cooperative Oncology Group (ECOG) score 0-3
  5. Patient is aged 18years or older.
  6. Patient is able to provide informed consent
  7. Patient is available for treatment and follow-up.

Exclusion Criteria:

  1. Benign histology.
  2. Prior malignancy within the previous five years or concurrent malignancy with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix.
  3. Prior radiotherapy to the target site
  4. Planned chemotherapy for (neo)adjuvant treatment
  5. Conservative surgery to the target site
  6. Presence of regional nodal disease or unequivocal distant metastases.
  7. Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up.

Sites / Locations

  • Dana Farber Cancer InstituteRecruiting
  • Cleveland Clinic Taussig Cancer InstituteRecruiting
  • Oregon Health & Science UniversityRecruiting
  • Cliniques Universitaires Saint-LucRecruiting
  • The Ottawa Hospital Cancer CentreRecruiting
  • Mount Sinai HospitalRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • Hopital Maisonneuve-RosemontRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Preoperative Radiation Therapy (Arm A)

Postoperative Radiation Therapy (Arm B)

Arm Description

Preoperative intensity modulated radiation therapy followed by surgery

Surgery followed by postoperative intensity modulated radiation therapy

Outcomes

Primary Outcome Measures

Incidence of acute wound healing complications
Secondary operations required for wound treatment (debridement, secondary closure procedures such as rotationplasty, free flaps or skin grafts); Readmission to hospital for wound care; Invasive procedures required for wound care (drainage of hematoma, seroma or infected wound collection); Deep wound packing required at any time (deep packing defined as packing deep to dermis in an area of dehisced wound) to an area of the wound measuring at least 2 cm in length; Prolonged dressing changes, including packing of the wound for greater than six weeks from wound breakdown; Repeat surgery for revision of a split thickness skin graft or requirement for wet dressings for longer than four weeks. (It is permissible for a patient to protect a totally epithelialized skin graft with a dry dressing without declaring a major wound complication) Use of vacuum-assisted closure (VAC)

Secondary Outcome Measures

Acute Radiation Toxicity
Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
Late Radiation Toxicity- RTOG Late Radiation Morbidity
Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
Late Radiation Toxicity- Common Toxicity Criteria
Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0
Late Radiation Toxicity- Limb Edema
Peripheral limb edema will be documented according to the Late Limb Edema Scoring Criteria.
Limb Function
Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale.
Patient function
Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS)
Overall Survival
Overall patient survival in months during the study period
Local recurrence-free survival
Patient survival without a local recurrence in months during the study period.
Metastasis-free survival
Patient survival without systemic metastases in months during the study period.

Full Information

First Posted
September 18, 2015
Last Updated
September 10, 2020
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Princess Margaret Hospital, Canada
search

1. Study Identification

Unique Protocol Identification Number
NCT02565498
Brief Title
Preoperative vs Postoperative IMRT for Extremity/Truncal STS
Official Title
Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is designed to determine if preoperative image guided radiation therapy (IGRT) delivered using intensity modulated radiation therapy (IMRT) followed by surgery results in similar short-term wound healing complications as surgery followed by postoperative IGRT in patients with extremity or truncal soft tissue sarcoma. Half of the patients will receive preoperative radiotherapy, half will receive postoperative radiotherapy.
Detailed Description
Perioperative RT in addition to surgery is widely accepted as standard management for soft tissue sarcoma (STS) of the extremity and trunk. However, controversy remains as to whether RT should be delivered preoperatively or postoperatively. While both confer similar rates of local control, preoperative RT leads to a decrease in late tissue morbidities such as fibrosis, limb edema, joint stiffness and fracture as compared to postoperative RT. The reasons for this are likely multifactorial, but are in part related to total dose delivered (50 Gray (GY) preoperatively and 60-66 Gy postoperatively) and, based on a previous National Cancer Institute (Canada) Phase III randomized controlled trial, the much larger volume treated in the postoperative setting compared to that in the preoperative setting. The optimal radiation dose used in the postoperative setting is unknown but has been developed empirically and doses of 60-66 Gy are generally employed.However, investigators in Norway/Sweden and France have found equivalent local control rates for patients with negative surgical margins treated with 50 GY postoperativelyThe main concern with preoperative RT has centered on the risk of an increased rate of delayed wound healing and major wound complications. Although some studies suggest it may be possible to reduce the incidence of acute wound healing complications associated with pre-operative radiation than previously seen in the 2D RT era, this has yet to be tested in the phase III setting. IG-IMRT allows a much higher degree of conformality and accurate delivery of dose to the tumour while sparing surrounding normal tissue. This may allow similar rates of acute wound healing complications for pre- and postoperative RT in the treatment of STS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Soft Tissue Sarcoma
Keywords
Soft tissue sarcoma, Extremity, Preoperative radiotherapy, Postoperative radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative Radiation Therapy (Arm A)
Arm Type
Other
Arm Description
Preoperative intensity modulated radiation therapy followed by surgery
Arm Title
Postoperative Radiation Therapy (Arm B)
Arm Type
Experimental
Arm Description
Surgery followed by postoperative intensity modulated radiation therapy
Intervention Type
Radiation
Intervention Name(s)
Preoperative intensity modulated radiation therapy
Intervention Description
50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision
Intervention Type
Radiation
Intervention Name(s)
Postoperative intensity modulated radiation therapy
Intervention Description
Surgery followed by 50 Gy delivered in 25 fractions within 6 weeks of surgery for patients with negative margins; for patients with positive margins a boost of 16 Gy in 8 fractions will be added.
Primary Outcome Measure Information:
Title
Incidence of acute wound healing complications
Description
Secondary operations required for wound treatment (debridement, secondary closure procedures such as rotationplasty, free flaps or skin grafts); Readmission to hospital for wound care; Invasive procedures required for wound care (drainage of hematoma, seroma or infected wound collection); Deep wound packing required at any time (deep packing defined as packing deep to dermis in an area of dehisced wound) to an area of the wound measuring at least 2 cm in length; Prolonged dressing changes, including packing of the wound for greater than six weeks from wound breakdown; Repeat surgery for revision of a split thickness skin graft or requirement for wet dressings for longer than four weeks. (It is permissible for a patient to protect a totally epithelialized skin graft with a dry dressing without declaring a major wound complication) Use of vacuum-assisted closure (VAC)
Time Frame
120 days post surgery
Secondary Outcome Measure Information:
Title
Acute Radiation Toxicity
Description
Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria.
Time Frame
Once per week from the start of radiotherapy until its completion (5 weeks in total), then 1 week preop for Group 1; 4 weeks post completion of treatment for Group 2
Title
Late Radiation Toxicity- RTOG Late Radiation Morbidity
Description
Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the RTOG/EORTC Late Radiation Morbidity Scoring Scheme.
Time Frame
Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.
Title
Late Radiation Toxicity- Common Toxicity Criteria
Description
Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0
Time Frame
Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.
Title
Late Radiation Toxicity- Limb Edema
Description
Peripheral limb edema will be documented according to the Late Limb Edema Scoring Criteria.
Time Frame
Every 3 months, from 3 months postop for Group 1 and 3 months post RT for Group 2, for 2 years, then 4 monthly for 1 year, then 6 monthly to 5 years.
Title
Limb Function
Description
Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale.
Time Frame
Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.
Title
Patient function
Description
Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS)
Time Frame
Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.
Title
Overall Survival
Description
Overall patient survival in months during the study period
Time Frame
Surgery Date until 5 years postoperative or death, whichever occurs first
Title
Local recurrence-free survival
Description
Patient survival without a local recurrence in months during the study period.
Time Frame
Surgery date until 5 years postoperative or local recurrence, whichever occurs first.
Title
Metastasis-free survival
Description
Patient survival without systemic metastases in months during the study period.
Time Frame
Surgery date until 5 years postoperative or systemic recurrence, whichever occurs first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven soft tissue sarcoma of the extremity or trunk following review by local reference pathologist. Deemed appropriate for preoperative or postoperative radiotherapy and conservative surgery following patient assessment by a radiation oncologist and surgical oncologist. Lesion is primary or locally recurrent. Patient may have undergone excisional biopsy with positive margins at a referring hospital and are eligible following discussion among the surgical oncologists and radiation oncologists that IMRT is an acceptable treatment for that case. Eastern Cooperative Oncology Group (ECOG) score 0-3 Patient is aged 18years or older. Patient is able to provide informed consent Patient is available for treatment and follow-up. Exclusion Criteria: Benign histology. Prior malignancy within the previous five years or concurrent malignancy with the exception of adequately treated basal cell carcinoma of the skin or carcinoma in-situ of the cervix. Prior radiotherapy to the target site Planned chemotherapy for (neo)adjuvant treatment Conservative surgery to the target site Presence of regional nodal disease or unequivocal distant metastases. Other major medical illness deemed to preclude safe administration of protocol treatment or required follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anthony Griffin, MSc
Phone
(416) 586-5975
Email
anthony.griffin@sinaihealth.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Colleen Dickie, MSc
Phone
(416) 946-2000
Ext
3467
Email
colleen.dickie@rmp.uhn.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ferguson, MD, FRCSC
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Chung, MD
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katerina Bubelo
Phone
617-582-8340
Email
katerina_bubelo@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Patrick Boyle
Phone
617-582-8918
Email
pjboyle@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Baldini, MD
Facility Name
Cleveland Clinic Taussig Cancer Institute
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Rerko
Phone
216-445-0640
Email
rerkom@ccf.org
First Name & Middle Initial & Last Name & Degree
Chirag Shah, MD
First Name & Middle Initial & Last Name & Degree
Nathan Mesko, MD
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erh-Ting Hsu, PhD
Phone
503-494-5345
Email
hsuer@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Kenneth Gundle, MD
First Name & Middle Initial & Last Name & Degree
Arthur Hung, MD
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeyneb El Mouch
Phone
+32 2 764 25 60
Email
zeyneb.elmouch@uclouvain.be
First Name & Middle Initial & Last Name & Degree
Thomas Schubert, MD, PhD
First Name & Middle Initial & Last Name & Degree
Xavier Geets, MD, PhD
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yusra Al Mosuli
Phone
(613) 737-8920
Email
yalmosuli@ohri.ca
First Name & Middle Initial & Last Name & Degree
Jean-Michel Caudrelier, MD
First Name & Middle Initial & Last Name & Degree
Joel Werier, MD
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Griffin, MSc
Phone
(416) 586-5975
Email
anthony.griffin@sinaihealth.ca
First Name & Middle Initial & Last Name & Degree
Peter Ferguson, MD
First Name & Middle Initial & Last Name & Degree
Jay Wunder, MD
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Colleen Dickie, MSc
Phone
(416) 946-4501
Ext
3467
Email
colleen.dickie@rmp.uhn.on.ca
First Name & Middle Initial & Last Name & Degree
Anthony M Griffin, MSc
Phone
14165865975
Email
anthony.griffin@sinaihealth.ca
First Name & Middle Initial & Last Name & Degree
Peter Chung, MD
First Name & Middle Initial & Last Name & Degree
Brian O'Sullivan, MD
First Name & Middle Initial & Last Name & Degree
Charles Catton, MD
First Name & Middle Initial & Last Name & Degree
David Shultz, MD
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo St.-Yves, MSc
Phone
1-514-252-3400
Ext
4428
Email
hstyves.hmr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Janie Barry, MSc
Phone
1-514-252-3400
Ext
4428
Email
jbarry.hmr@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Nader Khaouam, MD
First Name & Middle Initial & Last Name & Degree
Sophie Mottard, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Preoperative vs Postoperative IMRT for Extremity/Truncal STS

We'll reach out to this number within 24 hrs