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Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

NCT02828618Active, Not RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

AGO Study Group

Enrollment

797

Start Date

2016-07-01

Completion Date

2025-02-01

Study Type

INTERVENTIONAL

Official Title

Trial on Radical Upfront Surgery in Advanced Ovarian Cancer

Interventions

PDS (Primary Debulkdung Surgery)6 cycles of standard chemotherapyTiming of surgery after 3 cycles of standard NACTIDSIDS3 cycles of standard chemotherapy

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Outcome Measures

Primary Outcomes

overall survival (OS)

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).