Preoperative vs Postoperative IMRT for Extremity/Truncal STS

NCT02565498 | Active Not Recruiting Phase 3

• 1 other identifier: OCREB # 15-070
• Study Type: interventional
• Target: 210
• Locations: 3 countries
• Sites: 8

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.

Conditions

Adult Soft Tissue Sarcoma

Keywords

Soft tissue sarcoma; Extremity; Preoperative radiotherapy; Postoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

• 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)

  120 days post surgery

Secondary Outcomes (9)

• Acute Radiation Toxicity

  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

• Late Radiation Toxicity- RTOG Late Radiation Morbidity

  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.

• Late Radiation Toxicity- Common Toxicity Criteria

  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.

• Late Radiation Toxicity- Limb Edema

  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.

• Limb Function

  Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop.

Study Arms (2)

Preoperative Radiation Therapy (Arm A)

OTHER

Preoperative intensity modulated radiation therapy followed by surgery

Radiation: Preoperative intensity modulated radiation therapy

Postoperative Radiation Therapy (Arm B)

EXPERIMENTAL

Surgery followed by postoperative intensity modulated radiation therapy

Radiation: Postoperative intensity modulated radiation therapy

Interventions

Preoperative intensity modulated radiation therapy RADIATION

50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision

Preoperative Radiation Therapy (Arm A)

Postoperative intensity modulated radiation therapy RADIATION

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.

Postoperative Radiation Therapy (Arm B)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (8)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Location

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Peter Ferguson, MD, FRCSC

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Peter Chung, MD

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: October 1, 2015
• Study Start: June 1, 2016
• Primary Completion: October 1, 2024
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); US (3); CA (4)