Adjuvant Chemotherapy of Three-step Regimen in Ovarian Cancer

NCT02562365 | Unknown Phase 2

• 1 other identifier: FUSCC-OC1501
• Study Type: interventional
• Target: 130
• 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 6-8cycle of TP chemotherapy. 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.

Conditions

Ovarian Cancer

Keywords

adjuvent chemotherapy; ovarian cancer

Outcome Measures

Primary Outcomes (1)

• overall survival

  5 year

Secondary Outcomes (2)

• Progression-Free-Survival

  5 year

• Health-related quality of life

  5 year

Study Arms (2)

A: 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

B: Follow-up

NO INTERVENTION

No interevention

Interventions

Etoposide, Cyclophosphamide, Carboplatin DRUG

CTX 400mg（250mg/m2）+VP-16 100mg (70mg/m2)d1-d3 iv 4w/6cycles , CBP(AUC=5)+CTX 600mg(400mg/m2)d1-d2 iv 8w/6cycles

Also known as: VP-16,CTX,CBP

A: three steps chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients 18-70 years of age.
• ECOG 0-2
• Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer
• FIGO2014 stage IIIC/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,clear cell carcinoma, low grade carcinoma

Sponsors & Collaborators

• Xiaohua Wu MD: lead

Study Sites (1)

Wu Xiaohua

Shanghai, Shanghai Municipality, 200023, China

Location

Related Publications (1)

• Zheng Z, Wang H, Yang H, Tang J, Cheng X, Zhang M, Ren Y, Chen X, Ju X, Xu L, Wu X. Efficacy of Maintenance Therapy With Adjuvant Chemotherapy of Three Steps in Patients Newly Diagnosed With Advanced Ovarian Cancer: A Phase II Randomised Clinical Trial. BJOG. 2025 Jun;132(Suppl 4):52-61. doi: 10.1111/1471-0528.18178. Epub 2025 Apr 28.

  PMID: 40292604 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Etoposide; Cyclophosphamide; Carboplatin

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

Study Officials

• Xiaohua WU, PhD & MD

  Fudan university shanghai cancer center, Deparment of gynecologic oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fudan University Shanghai cancer center

Study Record Dates

• First Submitted: September 27, 2015
• First Posted: September 29, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

CN (1)