NCT02828618

Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 797 (actual)
• Sponsor: AGO Study Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: 1. Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study 2. 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. 3. 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. 4. Carboplatin AUC 5 - 6, q21 , 6 cycles in the case of contraindications of combination chemotherapy Group 2: Interval debulking surgery Patients allocated to the interval debulking surgery group undergo biopsy to confirm ovarian cancer and then 3 cycles of neoadjuvant preoperative platinum and taxane based chemotherapy. Then interval debulking surgery is performed followed by 3 cycles of postoperative platinum and taxane based chemotherapy Recommended systemic treatment Group 2: It is recommended to start systemic treatment as soon as possible after biopsy confirmation of ovarian cancer. The following treatments are recommended for neoadjuvant chemotherapy: 1. Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study 2. Carboplatin AUC5-6 / paclitaxel 175 mg/m² q21, 3 cycles. Substitution of paclitaxel by docetaxel (75mg/m²) in cases of contraindications to paclitaxel is possible. 3. Carboplatin AUC 5-6, q21 , 3 cycles in the case of contraindications of combination chemotherapy It is recommended to start postoperative chemotherapy after sufficient regeneration from interval debulking surgery, which will be ideally 2 to 6 weeks after surgery. The following treatments are recommended: 1. Participation in a prospective randomized trial, as long as participation is possible in case of randomization in either arm of the current study 2. Carboplatin AUC 5-6 / paclitaxel 175 mg/m² q21 / bevacizumab 15mg/KG q21, 3 cycles followed by bevacizumab maintenance therapy for a total of 15 months or until disease progression. 3. Carboplatin AUC5-6 / paclitaxel 175 mg/m² q21, 3 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. 4. Carboplatin AUC 5-6, q21 , 3 cycles in the case of contraindications of combination chemotherapy

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	PDS (Primary Debulkdung Surgery)	PDS with maximum effort to achieve the goal of complete gross resection
PROCEDURE	6 cycles of standard chemotherapy	6 cycles of standard chemotherapy after Primary Debuling Surgery
PROCEDURE	Timing of surgery after 3 cycles of standard NACT, IDS	Timing of surgery after 3 cycles of standard NACT
PROCEDURE	IDS	IDS with maximum effort to achieve the goal of complete gross resection after NACT
DRUG	3 cycles of standard chemotherapy	3 more cycles (for a total of 6) of standard chemotherapy after IDS

Timeline

• Start date: 2016-07-01
• Primary completion: 2025-02-01
• Completion: 2025-12-01
• First posted: 2016-07-11
• Last updated: 2025-10-03

Locations

20 sites across 8 countries: United States, Austria, Denmark, France, Germany, Italy, Sweden, United Kingdom