Prospective Study Evaluating the Treatment Outcomes for Localised Recurrent, Resectable Retroperitoneal Liposarcoma

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Abdominopelvic recurrence-free survival (ARFS). . [Срок оценки: Up to 5 years.]

Вторичные конечные точки (12)

• Overall survival [Срок оценки: Up to 5 years.]
• Cumulative incidence of 2nd local recurrence (in a competing risk framework) [Срок оценки: Up to 5 years.]
• Cumulative incidence of distant metastases (in a competing risk framework). [Срок оценки: Up to 5 years.]
• Cumulative incidence of in-field relapse for those who had preoperative radiotherapy (in a competing risk framework) [Срок оценки: Up to 5 years.]
• Pathological response using the EORTC-STBSG criteria. [Срок оценки: At surgical resection.]
• Radiology response to preoperative RT. [Срок оценки: Within 4 weeks of surgery.]
• Local disease progression during preoperative radiotherapy. [Срок оценки: During preoperative radiotherapy (for those patients that have preoperative radiotherapy)]
• Distant disease progression during preoperative RT. [Срок оценки: During preoperative radiotherapy (for those patients that have preoperative radiotherapy).]
• Toxicity of preoperative radiotherapy [Срок оценки: From the start of preoperative radiotherapy up to one week prior to surgery]
• Surgical complication [Срок оценки: Up to 60 days post surgery]
• Health related quality of life using the EORTC QLQ-C30 and the EORTC QLQ-STO22 assessment scales. [Срок оценки: 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 [Срок оценки: At surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• Pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 4 центра

• Emory Winship Cancer Institute — Atlanta
• Brigham and Women's Hospital — Boston
• OSU James Hospital — Columbus
• MD Anderson Cancer Center — Houston

Австралия · 3 центра

• Chris O'Brien Lifehouse — Camperdown
• Prince of Wales Hospital — Randwick
• Peter MacCallum Cancer Centre — Melbourne

Бельгия · 1 центр

• UZ Leuven — Leuven

Бразилия · 1 центр

• A.C.Camargo Cancer Center - Fundacao Antonio Prudente — Liberdade

Канада · 1 центр

• The Princess Margaret Cancer Centre — Toronto

Франция · 1 центр

• Institut Curie Hospital — Paris

Нидерланды · 1 центр

• The Netherlands Cancer Institute — Amsterdam

Польша · 1 центр

• Maria Sklodowska-Curie National Research Institute of Oncology — Warsaw

Идентификаторы

NCT: NCT07377747 · X23-0316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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