Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 13
- 主要终点
- Abdominopelvic recurrence-free survival (ARFS). .
研究概览
简要总结
The aim of the study is to collect prospective data on the treatment outcomes in patients with first localized, resectable recurrent retroperitoneal well-differentiated and/or dedifferentiated liposarcoma undergoing curative intent treatment. Patients enrolled in this study will form a validation cohort of the TARPSWG recurrent RPS nomogram. The treatment decision (surgery alone, or preoperative RT +/- chemotherapy followed by surgery) is per the institutional multidisciplinary team recommendation.
详细描述
This study is collecting participant data prospectively from hospital medical records. Participant details regarding diagnosis, treatments, outcomes, complications and survival status will be captured after patients are enrolled into the study and at specific time points though out the study. Participants will also be asked to complete quality of life questionnaires called the EORTC QLQ-C30 and the OLO-STO22 at 4 or 5 different time points which will take 15-20 minutes to complete. The overall duration of observation is from time of enrolment for 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult age ≥ 18 presenting with first recurrent well-differentiated and/or dedifferentiated liposarcoma of retroperitoneal space or pelvis after previous macroscopically complete resection (R0/R1 resection)
- •No distant metastasis on cross-sectional imaging of chest/abdomen/pelvis (CT and/or MRI) within 1 month to confirm the absence of metastatic disease
- •Previous histologically proven well-differentiated or dedifferentiated liposarcoma histology only
- •Sarcoma not originating from bone or abdominal or gynecological viscera
- •Tumor confirmed to be resectable with likely R0/R1 resection, and all disease must be deemed to be treatable by RT (joint decision by surgeon and radiation oncologist at a sarcoma multidisciplinary team meeting)
- •WHO performance status 0-2
- •American Society of Anaesthesiologist (ASA) score 1-3
- •No prior RT for the retroperitoneal liposarcoma
- •Prior systemic therapy is allowed
- •No concurrent active malignancy (except for low risk skin malignancy, low risk prostate carcinoma, low risk breast carcinoma including in situ disease)
- •Women of childbearing potential must have a negative pregnancy test within 3 weeks prior to the first day of study treatment
- •Patient deemed able to comply with study requirements according to investigator evaluation
- •Signed, IRB-approved written informed consent
排除标准
- •Unresectable disease or likely R2 resection as assessed by the multidisciplinary sarcoma team
- •Extent of recurrence where preoperative RT to all visible disease is not deemed to be feasible
- •Contradiction for RT such as history of bowel obstruction or mesenteric ischemia or severe chronic inflammatory bowel disease
- •Myxoid liposarcoma histology
研究组 & 干预措施
Surgery with preoperative radiotherapy
This includes patient who have had any chemotherapy.
Surgery without preoperative radiotherapy
This includes patients who had surgery alone, surgery with postoperative radiotherapy and/or any chemotherapy.
结局指标
主要结局
Abdominopelvic recurrence-free survival (ARFS). .
时间窗: Up to 5 years.
Defined as the time from the date of treatment start (either surgery, chemo or RT) for 1st recurrent LPS to the date of radiological abdominopelvic relapse or death whichever occurred first. Liver metastases will be regarded as distant metastatic events. rather than abdominopelvic relapse
次要结局
- Overall survival(Up to 5 years.)
- Cumulative incidence of 2nd local recurrence (in a competing risk framework)(Up to 5 years.)
- Cumulative incidence of distant metastases (in a competing risk framework).(Up to 5 years.)
- Cumulative incidence of in-field relapse for those who had preoperative radiotherapy (in a competing risk framework)(Up to 5 years.)
- Pathological response using the EORTC-STBSG criteria.(At surgical resection.)
- Radiology response to preoperative RT.(Within 4 weeks of surgery.)
- Local disease progression during preoperative radiotherapy.(During preoperative radiotherapy (for those patients that have preoperative radiotherapy))
- Distant disease progression during preoperative RT.(During preoperative radiotherapy (for those patients that have preoperative radiotherapy).)
- Toxicity of preoperative radiotherapy(From the start of preoperative radiotherapy up to one week prior to surgery)
- Surgical complication(Up to 60 days post surgery)
- Health related quality of life using the EORTC QLQ-C30 and the EORTC QLQ-STO22 assessment scales.(At registration, during the last week of RT treatment (preoperative RT patients only), within 2 weeks prior to surgery (for the preoperative RT patients), at 3 months and 12 months after surgery.)
- Unplanned R2 resection(At surgery)
- Stratified analysis of use of chemotherapy(Up to 5 years.)
- Validation of the recurrent RPS nomogram and the dynamic primary RPS nomogram(Up to 5 years.)