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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative Radiation Therapy (Arm A) | Other | Preoperative intensity modulated radiation therapy followed by surgery |
|
| Postoperative Radiation Therapy (Arm B) | Experimental | Surgery followed by postoperative intensity modulated radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative intensity modulated radiation therapy | Radiation | 50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute wound healing complications |
| 120 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Radiation Toxicity | Acute radiation skin toxicity will be documented according to the Radiotherapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Ferguson, MD, FRCSC | MOUNT SINAI HOSPITAL | Principal Investigator |
| Peter Chung, MD | Princess Margaret Cancer Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Cleveland Clinic Taussig Cancer Institute |
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| 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. |
|
| 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. |
| 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 | Late radiation morbidity to skin, subcutaneous tissue, bone and joints will be documented according to the Common Toxicity Criteria v4.0 | 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 | Peripheral limb edema will be documented according to the Late Limb Edema Scoring 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. |
| Limb Function | Limb function will be documented according to the Musculoskeletal Tumor Society Rating Scale. | Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop. |
| Patient function | Patient function will be documented according to the patient completed Toronto Extremity Salvage Score (TESS) | Within 14 days of randomization, then at 3 and 6 months, 1, 2, 3 and 5 years postop. |
| Overall Survival | Overall patient survival in months during the study period | Surgery Date until 5 years postoperative or death, whichever occurs first |
| Local recurrence-free survival | Patient survival without a local recurrence in months during the study period. | Surgery date until 5 years postoperative or local recurrence, whichever occurs first. |
| Metastasis-free survival | Patient survival without systemic metastases in months during the study period. | Surgery date until 5 years postoperative or systemic recurrence, whichever occurs first. |
| Cleveland |
| Ohio |
| 44195 |
| United States |
| Oregon Health & Science University | Portland | Oregon | 97239-3098 | United States |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium |
| The Ottawa Hospital Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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