Stratified Evaluation of PDS and NACT-IDS in Ovarian Cancer

Brief Title

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

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

Brief 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.

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.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Overall survival

Secondary Outcome

 Progression-free survival

Condition

Epithelial Ovarian Cancer

Intervention

Primary debulking surgery

Study Arms / Comparison Groups

 Part 1 Arm I (low/medium tumor burden)

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

January 2021

Completion Date

January 2028

Primary Completion Date

January 2028

Eligibility Criteria

For Part 1:

Inclusion Criteria:

1. Females aged ≥ 18 years.

2. 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:

1. the patient has a pelvic mass, and

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

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

3. cPCI score ≤ 8.

4. Performance status (ECOG 0-2).

5. Good ASA score (1/2).

6. Adequate bone marrow, renal and hepatic function to receive chemotherapy and
subsequent surgery:

1. white blood cells >3,000/µL, absolute neutrophil count ≥1,500/µL, platelets
≥100,000/µL, hemoglobin ≥9 g/dL,

2. 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,

3. serum bilirubin <1.25 x UNL, AST(SGOT) and ALT(SGPT) <2.5 x UNL.

7. Comply with the study protocol and follow-up.

8. Patients who have given their written informed consent.

Exclusion Criteria:

1. Non-epithelial ovarian malignancies and borderline tumors.

2. Low grade ovarian cancer.

3. Mucinous ovarian cancer.

4. cPCI score > 8.

5. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
or breast carcinoma (without any signs of relapse or activity).

6. Any other concurrent medical conditions contraindicating surgery or chemotherapy that
could compromise the adherence to the protocol.

7. 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:

Inclusion Criteria:

1. Females aged ≥ 18 years, and < 70 years.

2. Pathologic confirmed stage IIIC and IV epithelial ovarian cancer, fallopian tube
cancer or primary peritoneal carcinoma.

3. cPCI score ≥ 10.

4. 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.

5. Good performance status (ECOG 0-1).

6. Good ASA score (1/2).

7. Adequate bone marrow, renal and hepatic function to receive chemotherapy and
subsequent surgery.

8. Comply with the study protocol and follow-up.

9. Patients who have given their written informed consent.

Exclusion Criteria:

1. Non-epithelial ovarian malignancies and borderline tumors.

2. Low grade ovarian cancer.

3. Mucinous ovarian cancer.

4. Clear cell carcinoma.

5. cPCI score < 8.

6. Lung metastasis, diffused pleural metastasis, bone metastasis, metastasis of
mediastinal lymph node, internal mammary node, or multiple extra-peritoneal lymph
nodes.

7. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
or breast carcinoma (without any signs of relapse or activity).

8. Any other concurrent medical conditions contraindicating surgery or chemotherapy that
could compromise the adherence to the protocol.

9. Other conditions, such as religious, psychological and other factors, that could
interfere with provision of informed consent, compliance to study procedures, or
follow-up.

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 86 21 64041990, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04515602

Organization ID

FOCUS

Secondary IDs

SOC-4

Responsible Party

Sponsor

Study Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

 Obstetrics & Gynecology Hospital of Fudan University

Study Sponsor

, ,

Verification Date

August 2020