Spencer Ranyell Msb, Aguiar Junior Samuel, Ferreira Fabio O, Stevanato Filho Paulo R, Kupper Bruna Ec, Silva Maria Lg, Mello Celso A, Bezerra Tiago S, Lopes Ademar
Sarcoma and Colorectal Tumors, Pelvic Surgery Department, AC Camargo Cancer Center, São Paulo, Brazil.
Sarcoma and Colorectal Tumors, Radiation Therapy Department, AC Camargo Cancer Center, São Paulo, Brazil.
JMIR Res Protoc. 2017 May 25;6(5):e97. doi: 10.2196/resprot.6806.
Neoadjuvant radiotherapy (RT) and chemotherapy are applied to large, high-grade extremity soft tissue sarcomas to treat metastatic disease earlier and sterilize margins to perform R0 surgery. However, preoperative RT increases wound complication rates (rWC), delaying adjuvant chemotherapy or preventing it from being administered altogether. Hypofractionated neoadjuvant RT can be offered in this situation, concomitant to chemotherapy, allowing patients to receive chemotherapy as a preoperative treatment in less time with an acceptable rWC.
The objectives of this protocol are to maintain low rates of morbidity and mortality compared to literature data, improving survival rates and avoiding poor responders from receiving unnecessary adjuvant chemotherapy.
This noncontrolled, single-arm, phase 2 clinical trial recruited patients aged over 18 years with high-grade soft tissue sarcomas in the girdles or extremities. Three neoadjuvant chemotherapy (ifosfamide and doxorubicin) cycles were administered with 5 days of hypofractionated RT (25 Gy in 5 fractions) in the second cycle of doxorubicin only. Viable cell counts in the surgical specimen were measured, and patients in whom this value was less than 30% continued to receive an additional 3 full chemotherapy cycles as adjuvant treatment.
Primary endpoint will be disease-specific survival measured by the evaluation of local and distant recurrence after neoadjuvant treatment. The secondary endpoints will be wound complication and amputation rates and chemotherapy toxicity. We also will record the viable cell rates after the schema and correlate this with survival.
As seems with other solid tumors, hypofractionated RT has comparable efficacy and safety as conventional fractionation. This modality of treatment combined with chemotherapy could increase the pathological response rates and improve the outcomes of select patients.
ClinicalTrials.gov NCT02812654; https://clinicaltrials.gov/ct2/show/NCT02812654 (Archived by WebCite at http://www.webcitation.org/6qC3puBOy).
新辅助放疗（RT）和化疗应用于大型、高级别肢体软组织肉瘤，以便更早治疗转移性疾病并使切缘达到无菌状态，从而进行R0手术。然而，术前放疗会增加伤口并发症发生率（rWC），延迟辅助化疗或使其完全无法进行。在这种情况下，可以采用大分割新辅助放疗，并与化疗同时进行，使患者能够在更短时间内接受术前化疗，且伤口并发症发生率在可接受范围内。
本方案的目标是与文献数据相比，维持较低的发病率和死亡率，提高生存率，并避免无反应者接受不必要的辅助化疗。
这项非对照、单臂、2期临床试验招募了年龄超过18岁、患有骨盆带或肢体高级别软组织肉瘤的患者。仅在阿霉素的第二个周期给予三个新辅助化疗（异环磷酰胺和阿霉素）周期，并进行5天大分割放疗（25 Gy，分5次）。测量手术标本中的活细胞计数，该值小于30%的患者继续接受另外3个完整的化疗周期作为辅助治疗。
主要终点将是通过评估新辅助治疗后的局部和远处复发来衡量的疾病特异性生存。次要终点将是伤口并发症、截肢率和化疗毒性。我们还将记录方案实施后的活细胞率，并将其与生存情况相关联。
与其他实体瘤一样，大分割放疗与传统分割放疗具有相当的疗效和安全性。这种治疗方式与化疗相结合可以提高病理反应率，并改善部分患者的治疗效果。
ClinicalTrials.gov NCT02812654；https://clinicaltrials.gov/ct2/show/NCT02812654（由WebCite存档于http://www.webcitation.org/6qC3puBOy）。
