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

ConditionsEpithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorShanghai Gynecologic Oncology Group

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Females aged ≥ 18 years.

the patient has a pelvic mass, and

omental cake or other metastasis larger than 2 cm in the upper abdomen, or pathologic confirmed extra-abdominal metastasis (FIGO IV), and

preoperative CA125/CEA ratio > 25. If CA125/CEA ratio ≤ 25, imaging or endoscopy is obligatory to exclude a primary gastric, colon, or breast carcinoma.

Disqualifiers

Non-epithelial ovarian malignancies and borderline tumors.

Low grade ovarian cancer.

Mucinous ovarian cancer.

cPCI score > 8.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Primary debulking surgery

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

410 Participants
are divided into 4 treatment groups
Group A: Part 1 Arm I (low/medium tumor burden)Experimental treatment 2 interventions
Group B: Part 1 Arm II (low/medium tumor burden)Active comparator 2 interventions
Group C: Part 2 Arm I (high tumor burden)Experimental treatment 2 interventions
Group D: Part 2 Arm II (high tumor burden)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Time from randomization to the date of death from any cause or date of last contact

Time frame
Participants will be followed for at least 5 years after randomization

Secondary outcomes

1

Progression-free survival

Time from randomization to the date of first progressive disease or death, whichever occurs first or date of last contact

Time frame
Participants will be followed for at least 2 years after randomization
2

Post-operative complications

The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery

Time frame
Participants will be followed up to 3 months after randomization
3

Quality of life assessments

Quality of life (Qol) as measured by QOQ-C30

Time frame
Participants will be followed for at least 12 months or death after randomization, whichever came first
4

Quality of life assessments

Quality of life (Qol) as measured by FACT-O

Time frame
Participants will be followed for at least 12 months or death after randomization, whichever came first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Gynecologic Oncology Group

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University

Collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

Shanghai First Maternity and Infant Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: