Preoperative vs Postoperative IMRT for Extremity/Truncal STS

Titre officiel

Phase III Study of Preoperative vs Postoperative Intensity Modulated Radiation Therapy For Truncal/Extremity Soft Tissue Sarcoma

Sommaire:

Cette étude a été conçue pour déterminer si des procédures préopératoires de radiothérapie guidée par imagerie (IGRT) effectuées par radiothérapie à modulation d'intensité (IMRT) et suivies d'une intervention chirurgicale entraînent les mêmes problèmes de guérison des plaies à court terme qu'une intervention chirurgicale suivie d'une IGRT postopératoire chez des patients atteints d'un sarcome des tissus mous des extrémités des membres ou du tronc. La radiothérapie sera préopératoire pour la moitié des patients et postopératoire pour l'autre.

Description de l'essai

Primary Outcome:

• Incidence of acute wound healing complications

Secondary Outcome:

• Acute Radiation Toxicity
• Late Radiation Toxicity- RTOG Late Radiation Morbidity
• Late Radiation Toxicity- Common Toxicity Criteria
• Late Radiation Toxicity- Limb Edema
• Limb Function
• Patient function
• Overall Survival
• Local recurrence-free survival
• Metastasis-free survival

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 centreed 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.

Voir cet essai sur ClinicalTrials.gov