Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)

Sponsor
Shanghai Gynecologic Oncology Group
Study ID
NCT04515602
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Primary debulking surgery — PROCEDURE
    Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
  • Neoadjuvant chemotherapy — PROCEDURE
    3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
  • PARPi — DRUG
    For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.

Study Details

The purpose of this study is to answer the fundamental question 'The Optimal Timing of Surgery' in advanced ovarian cancer patients with different tumor burden, and to perform translational study.

Key Dates

First listed
Aug 17, 2020
Start date
Jan 31, 2021
Status verified
Aug 2020
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 Arm I (low/medium tumor burden)
    Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.
  • Active Comparator: Part 1 Arm II (low/medium tumor burden)
    Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.
  • Experimental: Part 2 Arm I (high tumor burden)
    Primary debulking surgery with a maximal cytoreduction of complete gross resection within 3 weeks after biopsy, followed by at least 6 cycles of adjuvant chemotherapy and maintenance therapy for patients with gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.
  • Active Comparator: Part 2 Arm II (high tumor burden)
    Neoadjuvant chemotherapy with 3 cycles of chemotherapy, then followed by interval debulking surgery. The maximal time interval between course 3 chemotherapy and IDS is 6 weeks. And then 3 cycles of adjuvant chemotherapy and maintenance therapy for patients with gBRCA/sBRCA mutation, CR/PR after platinum-based therapy.

Primary Outcome Measure

Overall survival [ Time Frame: Participants will be followed for at least 5 years after randomization ]

Central Contacts

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