Clinical trial · Interventional
Adjuvant Chemotherapy of Three-step Regimen in Ovarian Cancer
A Phase II,Randomized Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in Stage IIIc and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoposide, Cyclophosphamide, Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: three steps chemotherapy
- description
- 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.
- interventionNames
- Drug: Etoposide, Cyclophosphamide, Carboplatin
- type
- NO_INTERVENTION
- label
- B: Follow-up
- description
- No interevention
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 5 year
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. 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,clear cell carcinoma, low grade carcinoma
References
Publications (1)
- DERIVEDZheng 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