Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)

July 25, 2022 updated by: Xiaohua Wu MD, Fudan University

A Phase III,Randomized, Multi-center, Open Label Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in BRCA1/2 Wide-type Stage III and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)

Ovarian cancer was mostly diagnosed at late stage (III/IV) with high rate of recurrence after first line of therapy by optimal cytoreductive sugery and 6cycle of TP chemotherapy. There is no standard maintainance therapy for BRCA1/2 wide-type ovarian cancer. We developed an adjuvant chemotherapy of "three steps" (ACTS). It is adding CTX+VP-16(second step) 6cycle and CTX+CBP(third steps) to firstline chemotherapy (first step). The aim of this study is to verify the effectivity and safety of ACTS in BRCA1/2 wide-type ovarian cancer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

More than 70 percent of ovarian cancer patients were diagnosed in the advanced stage. Currently the 5-year disease free survival (DFS) of stageⅢ-Ⅳovarian cancer patients was about 10 percent after first line chemotherapy. Dr Cai shumo developed adjuvant chemotherapy of "three steps" (ACTS) for advanced ovarian cancer after cytoreductive surgery, based on his 60+ years experience on gynecologic oncology. After the first step 6-8 cycle paclitaxel plus carboplatin chemotherapy, the chemo-sensative cancer cells were killed, but resistant/dormancy cell remained. The second step chemotherapy which is 6 cycle CTX+VP-16 every 4weeks, using different mechanism to kill cancer cells, may decrease the rate of recurrence within 6 month after first step chemotherapy, prolong platinum-free duration and also with acceptable side effects. After second step chemotherapy, in absence of 6 months platinum treatment, the previous G0 dormancy cell may become flexible to platinum treatment. Therefore, in the third step chemotherapy, CTX+CBP is used in every 8 week for 6 cycles. Comparing to using targeted therapy for maintaining therapy, the ACTS cost less.

In the previous observation study(CHINA ONCOLOGY 2013 Vol.23 No.12 p980), In study arm A, the patients received three-step chemotherapy after primary debulking surgery, step one with paclitaxel plus carboplatin (TC regimen), every 3 weeks for 6 to 8 cycles; step two with etoposide plus cyclophosphamide, every 4 weeks for 6 cycles; step three with carboplatin plus cyclophosphamide every eight weeks for six cycles. In control arm B, investigators retrospectively analysed 51 cases withⅢC-Ⅳstage ovarian cancer, who had completely response after standard chemotherapy with six to eight cycles of TC after primary surgery during 2007. Investigators compared the 5-year DFS between the two arms. Results: The 5-year DFS of 15 cases in arm A was 80%(12/15), which was signiifcantly higher than that of arm B (5.9%, 3/51, P<0.01). Therefore we start this randomized open control clinic trial to evaluated the effect of ACTS on overall survival and its safety.

In2015, we launched ACTS study (NCT02562365), and the primary results showed benefit of ACTS on PFS and acceptable AE. Currently, PARP inhibit was shown to be effective in maintainance therapy in ovarian cancer especially approve for BRCA1/2 mutated pateints. However there is no standard maintainance therapy for BRCA1/2 wide-type ovarian cancer. Here we started ACTS-2 study to verify the effectivity and safety of ACTS in BRCA1/2 wide-type ovarian cancer patients.

Study Type

Interventional

Enrollment (Anticipated)

590

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: zhong zheng, dr
  • Phone Number: 66073 862164175590
  • Email: alizheng@126.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200023
        • Recruiting
        • Wu Xiaohua
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female patients 18-75 years of age.
  • ECOG 0-2
  • Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer
  • FIGO2018 stage III/IV,
  • Patients should have received optimal cytoreductive surgery with residual tumor ≤ 1cm and no more than 9 cycle paclitaxel + platinum chemotherapy achieved complete remission (accessed ) and normal CA125.
  • No more than 8 months after the last chemotherapy.
  • Adequate bone marrow and hepatic function at Screening:
  • Hemoglobin ≥9 g/dL
  • White blood cell count ≥3.0 × 109/L
  • Absolute neutrophil count ≥1.5 × 109/L
  • Platelet count ≥100 × 109/L
  • AST (SGOT)/ALT (SGPT) ≤2.5 ULN
  • Bilirubin <1.5 × ULN
  • Creatinine <1.5 × ULN.
  • Ability and willingness to give written informed consent.
  • Tumor BRCA1/2 wilde type (qualified center test)

Exclusion Criteria:

  • Primary or secondary immune deficiency.
  • Any uncontrolled medical condition that may put the patient at high risk during treatment .
  • Receipt of any other investigational medicinal product within the last 30 days before randomization.
  • Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, Ductal Carcinoma in Situ (DCIS), stage 1 grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥ 5 years.
  • Severe heart/ lung/ liver/ kidney failure.
  • uncontroled or active infection disease.
  • Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
  • Receipt of pelvic or abdominal radiotherapy
  • Mucinous adenocarcinoma, low grade carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Follow-up
No interevention
Experimental: three steps chemotherapy
Cyclophosphamide 400mg（250mg/m2）+Etoposide 100mg (70mg/m2)d1-d3 iv 4w/6cycles , followed by Carboplatin (AUC=5)+Cyclophosphamide 600mg(400mg/m2)d1-d2 iv 8w/6cycles.
Drug: Etoposide, Cyclophosphamide, Carboplatin/Cisplatin
CTX 400mg（250mg/m2）+VP-16 100mg (70mg/m2)d1-d3 iv 4w/6cycles , CBP(AUC=5) d1/CDDP 30mg/m2 d1-d2+CTX 600mg(400mg/m2)d1-d2 iv 8w/6cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free-Survival (PFS)
Time Frame: three year
three year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival (OS)
Time Frame: five year
five year
Health-related quality of life questionnaire
Time Frame: three year
three year
Adverse Events (AE)
Time Frame: three year
three year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Anticipated)

September 1, 2027

Study Completion (Anticipated)

September 1, 2030

Study Registration Dates

First Submitted

August 18, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 20, 2020

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDUSCC-ACTS2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

data is available per require after approved by ethics broad.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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