Neoadjuvant irradiation of retroperitoneal soft tissue sarcoma with ions (Retro-Ion): study protocol for a randomized phase II pilot trial.

BACKGROUND: Following surgery for soft tissue sarcoma of the retroperitoneum, the predominant pattern of failure is local recurrence, which remains the main cause of death. Radiotherapy is utilized to reduce recurrence rates but the efficacy of this strategy has not been definitely established. As treatment tolerability is more favorable with preoperative radiotherapy, normofractionated neoadjuvant treatment is the current approach. The final results of the prospective, randomized STRASS (EORTC 62092) trial, which compared the efficacy of this combined treatment to that of surgery alone, are still awaited; preliminary results presented at the 2019 ASCO Annual Meeting indicated that combined treatment is associated with better local control in patients with liposarcoma (74.5% of the cohort, 11% benefit in abdominal progression free survival after 3 years, p = 0.049). Particles allow better sparing of surrounding tissues at risk, e.g., bowel epithelium, and carbon ions additionally offer biologic advantages and are preferred in slow growing tumors. Furthermore, hypofractionation allows for a significantly shorter treatment interval with a lower risk of progression during radiotherapy. METHODS AND DESIGN: We present a prospective, randomized, monocentric phase II trial. Patients with resectable or marginally resectable, histologically confirmed soft tissue sarcoma of the retroperitoneum will be randomized between neoadjuvant proton or neoadjuvant carbon ion radiotherapy in active scanning beam application technique (39 Gy [relative biological effectiveness, RBE] in 13 fractions [5-6 fractions per week] in each arm). The primary objective is the safety and feasibility based on the proportion of grade 3-5 toxicity (CTCAE, version 5.0) in the first 12 months after surgery or discontinuation of treatment for any reason related to the treatment. Local control, local progression-free survival, disease-free survival, overall survival, and quality of life are the secondary endpoints of the study. DISCUSSION: The aim of this study is to confirm that hypofractionated, accelerated preoperative radiotherapy is safe and feasible. The rationale for the use of particle therapy is the potential for reduced toxicity. The data will lay the groundwork for a randomized phase III trial comparing hypofractionated proton and carbon ion irradiation with regard to local control. TRIAL REGISTRATION: ClinicalTrials.gov NCT04219202 . Retrospectively registered on January 6, 2020.

Comparison of the Rubin dermal suspension sutures and total parenchymal reshaping technique with a traditional inverted T-scar reduction mammaplasty technique using a superior pedicle.

UNLABELLED: Adipose patients, especially after massive weight loss, pose a challenge to the breast surgeon due to the major loss of volume and the inelasticity of the skin. Rubin described a suitable mammaplasty technique for these patients involving dermal suspension sutures and total parenchymal reshaping. With this technique, the tissue of the prominent axillary skin fold typically found in patients with massive weight loss is used to increase the upper pole volume of the breast. To prove the effectiveness of this technique, the current study compared it with a traditional inverted T-scar technique using a superior pedicle, as described by Höhler. This technique usually is used for a different patient clientele that requires reduction mammaplasty. However, because none of the difficult aforementioned preconditions are found in this clientele, it leads to the best possible outcome and represents the authors' internal "gold standard" for mammaplasty against which all other techniques must be compared. This study retrospectively analyzed the complication rate, lift effect, and upper pole fullness by chart analysis and photometric analysis of 21 Höhler and 24 Rubin mammaplasties. Despite the more challenging patient clientele in the Rubin groups, both therapies achieved a similar lift effect without significant differences (Höhler 4.8 ± 3.3 cm vs Rubin 6 ± 4 cm). In both groups, the upper pole area increased significantly. The ratio of upper pole-to-lower pole area increased from 1.31 preoperatively to 2.1 postoperatively in the Rubin group, suggesting a redistribution of tissue in favor of the upper pole, and it increased from 1.18 to 1.69 in the Höhler group, indicating an even greater increase in upper pole volume in the Rubin group. In conclusion, the technique described by Rubin, despite the dramatically more difficult soft tissue condition of the patients with massive weight loss, results in an outcome similar to that of a traditional reduction mammaplasty technique in terms of increased upper pole volume. It is suitable and preferable for patients who have a lateral axillary roll deformity and can be applied safely for these patients without increasing the complication rate. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.