Trial on Radical Upfront Surgery in Advanced Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 797
- 试验地点
- 20
- 主要终点
- overall survival (OS)
研究概览
简要总结
This study consists of three parts, whereas Part 1 and Part 2 are performed in Germany only, and Part 3 is a multinational trial.
All patients with suspicion of advanced ovarian cancer are detected in the participating study centers in a pre-screening. The study centers will register all patients with suspected ovarian cancer in a screening log. After the patients have given informed consent, they can be enrolled in different parts of the study.
TRUST-Trial: This part compares two strategies in the therapy of advanced ovarian cancer. En detail, this part of the trial will evaluate if one of two strategies of timing surgery within the therapeutic procedures may show any significant advances in terms of overall survival over the other.
详细描述
Both randomised groups are treated with surgery for complete resection following guideline recommendations and including median laparotomy, complete adhesiolysis, hysterectomy, bilateral salpingo-oophorectomy, omentectomy and (partial) resection of all affected organs (e.g. small or large bowel, peritoneum, spleen, pancreas, peritoneum, urinary tract etc.) as well as pelvic and paraaortic lymphadenectomy if indicated. Patients with significant pleural effusion (>500 mL in the right chest or any pleural effusion in the left chest, assessed either through ultrasound or CT scan) need to undergo video assisted thoracoscopy or open assessment of the pleura prior or during debulking surgery to detect and if possible remove intrathoracic disease.
Group 1: Primary debulking surgery Patients allocated to the primary debulking group undergo surgery followed by 6 cycles of platinum and taxane based chemotherapy.
Recommended systemic treatment Group 1:
It is recommended to start systemic treatment after sufficient regeneration from surgery [45], which will be ideally 2 to 6 weeks (but at the latest 8 weeks) after surgery. The following treatments are recommended:
- Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21 / bevacizumab 15mg/KG q21, 6 cycles followed by bevacizumab maintenance therapy for a total of 15 months or until disease progression.
- Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21, 6 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible. Maintenance/consolidation therapy inside prospective trials or according to national standard treatments is allowed. Additional treatment outside prospective studies is not recommended.
- Carboplatin AUC 5 - 6, q21 , 6 cycles in the case of contraindications of combination chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis)
- •Females aged ≥ 18 years
- •Patients who have given their written informed consent
- •Good performance status (ECOG 0/1)
- •Good ASA score (1/2)
- •Preoperative CA 125/CEA ratio ≥ 25 (if CA-125 is elevated)*
- •If <25 and/or biopsy with non-serous, non-endometroid histology, esophago-gastro-duodenoscopy (EGD) and colonoscopy mandatory to exclude gastrointestinal primary cancer
- •Assessment of an experienced surgeon, that based on all available information, the patient can undergo the procedure and the tumor can potentially be completely resected
- •Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. This ANC cannot have been induced or supported by granulocyte colony stimulating factors.
- •Platelet count ≥ 100 x 109/L.
- •Renal function: Serum-Creatinine ≤ 1.5 x institutional upper limit normal (ULN).
- •Hepatic function:
- •Bilirubin ≤ 1.5 x ULN.
- •SGOT ≤ 3 x ULN
- •Alkaline phosphatase ≤ 2.5 x ULN.
- •Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1.
排除标准
- •Non epithelial ovarian malignancies and borderline tumors
- •Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity.
- •Recurrent ovarian cancer
- •Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy
- •Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis
- •Clinical relevant dysfunctions of blood clotting (including drug induced)
- •Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator)
- •Pregnancy
- •Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent
- •Any reasons interfering with regular follow-up
研究组 & 干预措施
Arm I PDS and chemotherapy
PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy
干预措施: PDS (Primary Debulkdung Surgery) (Procedure)
Arm I PDS and chemotherapy
PDS with maximum effort to achieve the goal of complete gross resection then followed by 6 cycles of standard chemotherapy
干预措施: 6 cycles of standard chemotherapy (Procedure)
Arm II Timing of surgery after 3 cycles of SOC CTX
3 cycles of standard NACT followed by IDS with maximum effort to achieve the goal of complete gross resection followed by 3 more cycles (for a total of 6) of standard chemotherapy
干预措施: Timing of surgery after 3 cycles of standard NACT, IDS (Procedure)
Arm II Timing of surgery after 3 cycles of SOC CTX
3 cycles of standard NACT followed by IDS with maximum effort to achieve the goal of complete gross resection followed by 3 more cycles (for a total of 6) of standard chemotherapy
干预措施: IDS (Procedure)
Arm II Timing of surgery after 3 cycles of SOC CTX
3 cycles of standard NACT followed by IDS with maximum effort to achieve the goal of complete gross resection followed by 3 more cycles (for a total of 6) of standard chemotherapy
干预措施: 3 cycles of standard chemotherapy (Drug)
结局指标
主要结局
overall survival (OS)
时间窗: Patients will be followed up for a minimum of 5 years after registration/randomisation or until death
To compare the overall survival (OS) after primary debulking surgery (PDS) versus interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) in patients with FIGO (2014) stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma. The primary endpoint overall survival time is calculated from the date of randomization until the date of death from any cause or date of last contact (censored observation).
次要结局
- Progression-free survival (PFS)(Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
- Documentation of surgical complications(Patients will be followed up for 1 year after surgery or until death)
- Progression-free survival 2 (PFS2)(Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
- Time to first subsequent anticancer therapy or death (TFST)(Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
- Time to second subsequent anticancer therapy or death (TSST)(Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)
- Quality of life (QoL)(Patients will be followed up for a minimum of 5 years after registration/randomisation or until death)