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

NCT04520074 | Recruiting Phase 3

• 1 other identifier: FDUSCC-ACTS2
• Study Type: interventional
• Target: 590
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ovarian Cancer

Keywords

adjuvent chemotherapy, ovarian cancer, maitainance therapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival (PFS)

  three year

Secondary Outcomes (3)

• overall survival (OS)

  five year

• Health-related quality of life questionnaire

  three year

• Adverse Events (AE)

  three year

Study Arms (2)

Follow-up

NO INTERVENTION

No interevention

three steps chemotherapy

EXPERIMENTAL

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

Interventions

Etoposide, Cyclophosphamide, Carboplatin/Cisplatin DRUG

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

three steps chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Wu Xiaohua

Shanghai, Shanghai Municipality, 200023, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Etoposide; Cyclophosphamide; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Central Study Contacts

zhong zheng, dr

CONTACT

862164175590; alizheng@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of gynecologic oncology, Fudan University shanghai cancer center

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: October 8, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)