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Spots Global Cancer Trial Database for Preoperative vs Postoperative IMRT for Extremity/Truncal STS

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Trial Identification

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 ID: NCT02565498

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio, United States

Oregon Health & Science University, Portland, Oregon, United States

Cliniques Universitaires Saint-Luc, Brussels, , Belgium

The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada

Mount Sinai Hospital, Toronto, Ontario, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada

Contact Details

Name: Peter Ferguson, MD, FRCSC

Affiliation: MOUNT SINAI HOSPITAL

Role: PRINCIPAL_INVESTIGATOR

Name: Peter Chung, MD

Affiliation: Princess Margaret Cancer Centre

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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