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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

Status

Not yet recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Primary debulking surgery

Neoadjuvant chemotherapy

PARPi

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

For Part 1:

Inclusion Criteria:

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:
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.
cPCI score ≤ 8.
Performance status (ECOG 0-2).
Good ASA score (1/2).
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.
Comply with the study protocol and follow-up.
Patients who have given their written informed consent.

Exclusion Criteria:

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.
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:

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.

Exclusion Criteria:

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.

Sites / Locations

Zhongshan Hospital Fudan University
Obstetrics & Gynecology Hospital of Fundan University
Shanghai First Maternity and Infant Hospital
Shanghai Jiao Tong University School of Medicine Xinhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Part 1 Arm I (low/medium tumor burden)

Part 1 Arm II (low/medium tumor burden)

Part 2 Arm I (high tumor burden)

Part 2 Arm II (high tumor burden)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Overall survival

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

Secondary Outcome Measures

Progression-free survival

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

Post-operative complications

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

Quality of life assessments

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

Quality of life assessments

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

Accumulating treatment-free survival

The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, regardless of the targeted therapy

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

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

Progression-free survival 2

Time from randomization to second progressive disease or death, which occurs first or date of last contact

Full Information

NCT ID

NCT04515602

First Posted

August 14, 2020

Last Updated

August 25, 2020

Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Obstetrics & Gynecology Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai First Maternity and Infant Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04515602

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 2021 (Anticipated)

Primary Completion Date

January 2028 (Anticipated)

Study Completion Date

January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Gynecologic Oncology Group

Collaborators

Obstetrics & Gynecology Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai First Maternity and Infant Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

410 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Part 1 Arm I (low/medium tumor burden)

Arm Type

Experimental

Arm Description

Arm Title

Part 1 Arm II (low/medium tumor burden)

Arm Type

Active Comparator

Arm Description

Arm Title

Part 2 Arm I (high tumor burden)

Arm Type

Experimental

Arm Description

Arm Title

Part 2 Arm II (high tumor burden)

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Primary debulking surgery

Other Intervention Name(s)

PDS

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Neoadjuvant chemotherapy

Other Intervention Name(s)

Neoadjuvant chemotherapy followed by interval debulking surgery, NACT-IDS

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

PARPi

Intervention Description

For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.

Primary Outcome Measure Information:

Title

Overall survival

Description

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 Outcome Measure Information:

Title

Progression-free survival

Description

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

Title

Post-operative complications

Description

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

Title

Quality of life assessments

Description

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

Title

Quality of life assessments

Description

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

Title

Accumulating treatment-free survival

Description

The overall survival time minus the total treatment time of surgery and chemotherapy after randomization, regardless of the targeted therapy

Time Frame

Participants will be followed for at least 5 years or death after randomization, whichever came first

Title

Time to first subsequent anticancer therapy

Description

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

Time Frame

Participants will be followed for at least 2 years or death after randomization, whichever came first

Title

Time to secondary subsequent anticancer therapy

Description

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

Time Frame

Participants will be followed for at least 5 years or death after randomization, whichever came first

Title

Progression-free survival 2

Description

Time from randomization to second progressive disease or death, which occurs first or date of last contact

Time Frame

Participants will be followed for at least 5 years or death after randomization, whichever came first

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

For Part 1: Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lina Shen, MD

Phone

86 21 64041990

shen.lina@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Tingyu Luan

Phone

86 21 64041990

luan.yuting@zs-hospital.sh.cn

Facility Information:

Facility Name

Zhongshan Hospital Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Obstetrics & Gynecology Hospital of Fundan University

City

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Wei Jiang, MD, PhD

Phone

86 21 33189900

Facility Name

Shanghai First Maternity and Infant Hospital

City

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xiaoqing Guo, MD, PhD

Phone

86 21 20261000

Facility Name

Shanghai Jiao Tong University School of Medicine Xinhua Hospital

City

Shanghai

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xipeng Wang, MD, PhD

Phone

86 21 25078999

12. IPD Sharing Statement

Plan to Share IPD

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

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