Epithelial Ovarian CancerPhase 3NCT04515602
Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer (FOCUS)
A Phase 3 study testing Primary debulking surgery, Neoadjuvant chemotherapy and PARPi in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 4 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Primary debulking surgery, Neoadjuvant chemotherapy and PARPi
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 4 sitesChina
- Study dates
- Jan 2021to Jan 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females aged ≥ 18 years.
- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma (diagnosis by biopsy or core needle biopsy*, laparoscopic biopsy is not recommended). * If core needle biopsy could not be performed, patients should satisfy the following conditions:
- 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.
- cPCI score ≤ 8.
Show all 23Show fewer
- Performance status (ECOG 0-2).
- Good ASA score (1/2).
- Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery:
- white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
- serum creatinine <1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement,
- serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.
- Comply with the study protocol and follow-up.
- Patients who have given their written informed consent.
- Females aged ≥ 18 years, and < 70 years.
- Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal carcinoma.
- cPCI score ≥ 10.
- For FIGO IVB patients, abdominal lesions should be confined to one lobe of liver parenchyma metastasis or splenic metastasis. All extra-abdominal metastases should be resectable, such as inguinal lymph nodes, solitary supraclavicular, retrocrural or paracardial nodes.
- Good performance status (ECOG 0-1).
- Good ASA score (1/2).
- Adequate bone marrow, renal and hepatic function to receive chemotherapy and subsequent surgery.
- Comply with the study protocol and follow-up.
- Patients who have given their written informed consent.
Who cannot join
- Non-epithelial ovarian malignancies and borderline tumors.
- Low grade ovarian cancer.
- Mucinous ovarian cancer.
- cPCI score > 8.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
Show all 17Show fewer
- Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
- For Part 2:
- Non-epithelial ovarian malignancies and borderline tumors.
- Low grade ovarian cancer.
- Mucinous ovarian cancer.
- Clear cell carcinoma.
- cPCI score < 8.
- Lung metastasis, diffused pleural metastasis, bone metastasis, metastasis of mediastinal lymph node, internal mammary node, or multiple extra-peritoneal lymph nodes.
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ or breast carcinoma (without any signs of relapse or activity).
- Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol.
- Other conditions, such as religious, psychological and other factors, that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Obstetrics & Gynecology Hospital of Fundan University
Shanghai
Wei Jiang, MD, PhD, 86 21 33189900
Shanghai First Maternity and Infant Hospital
Shanghai
Xiaoqing Guo, MD, PhD, 86 21 20261000
Shanghai Jiao Tong University School of Medicine Xinhua Hospital
Shanghai
Xipeng Wang, MD, PhD, 86 21 25078999
About this study
Official title: Stratified Evaluation and Prediction of Survival Benefit for PDS or NACT-IDS in Advanced Ovarian Cancer, A Randomized, Phase 3 Trial After the SUNNY Study
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.
Read the detailed description
OBJECTIVES: Compare the efficacy and safety in patients with advanced ovarian cancer treated with NACT-IDS versus PDS, among different tumor burden groups. Compare survival benefit of PARPi therapy in patients treated with PDS or NACT-IDS.
OUTLINE: This is a randomized phase III multicenter study. Patients will receive upfront maximal cytoreductive surgery followed by at least 6 cycles of adjuvant chemotherapy or 3 cycles of neoadjuvant chemotherapy followed by interval debulking surgery, and then at least 3 cycles of adjuvant chemotherapy, and maintenance therapy of PARP inhibitor for patients with gBRCA/sBRCA mutation who had a complete or partial clinical response after platinum-based chemotherapy. Patients are followed every 3 months within the first 5 years, and then every 6 months.
PROJECTED ACCRUAL: A total of 410 patients will be accrued for this study within 3 years.
- Being tested
- Primary debulking surgery, Neoadjuvant chemotherapy, PARPi
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary debulking surgeryProcedure or surgery
Also called PDS
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 chemotherapyProcedure or surgery
Also called Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS
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.
PARPiDrug
For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Arm I (low/medium tumor burden) | Experimental | 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. Receives: Procedure: Primary debulking surgery; Drug: PARPi |
| Part 1 Arm II (low/medium tumor burden) | Active comparator | 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. Receives: Procedure: Neoadjuvant chemotherapy; Drug: PARPi |
| Part 2 Arm I (high tumor burden) | Experimental | 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. Receives: Procedure: Primary debulking surgery; Drug: PARPi |
| Part 2 Arm II (high tumor burden) | Active comparator | 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. Receives: Procedure: Neoadjuvant chemotherapy; Drug: PARPi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from randomization to the date of death from any cause or date of last contact
Measured: Participants will be followed for at least 5 years after randomization
Secondary outcomes (8)
Progression-free survival
Time from randomization to the date of first progressive disease or death, whichever occurs first or date of last contact
Measured: Participants will be followed for at least 2 years after randomization
Post-operative complications
The surgical complications will be evaluated at 30-day, 60-day, 90-day after upfront cytoreductive surgery or interval debulking surgery
Measured: Participants will be followed up to 3 months after randomization
Quality of life assessments
Quality of life (Qol) as measured by QOQ-C30
Measured: Participants will be followed for at least 12 months or death after randomization, whichever came first
Quality of life assessments
Quality of life (Qol) as measured by FACT-O
Measured: Participants will be followed for at least 12 months or death after randomization, whichever came first
Accumulating treatment-free survival
The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, regardless of the targeted therapy
Measured: Participants will be followed for at least 5 years or death after randomization, whichever came first
Time to first subsequent anticancer therapy
Time from the date of randomization to the starting date of the first subsequent anticancer therapy or death, whichever occurs first or date of last contact
Measured: Participants will be followed for at least 2 years or death after randomization, whichever came first
Time to secondary subsequent anticancer therapy
Time from the date of randomization to the starting date of the second subsequent anticancer therapy or death, whichever occurs first or date of last contact
Measured: Participants will be followed for at least 5 years or death after randomization, whichever came first
Progression-free survival 2
Time from randomization to second progressive disease or death, which occurs first or date of last contact
Measured: Participants will be followed for at least 5 years or death after randomization, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study startJan 2021 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Collaborators
- Obstetrics & Gynecology Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai First Maternity and Infant Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04515602
- Sponsor's protocol ID
- FOCUS
- Other IDs
- SOC-4, SGOG-OV6
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No