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A Phase II, Randomized Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in Stage IIIc andStage IV Epithelial Ovarian, Fallopian Tube, andPrimary Peritoneal Cancer (EOC, FTC, PPC)

A Phase II, Randomized Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in Stage IIIc andStage IV Epithelial Ovarian, Fallopian Tube, andPrimary Peritoneal Cancer (EOC, FTC, PPC)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15007154
Enrollment
Unknown
Registered
2015-09-27
Start date
2015-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epithelial Ovarian, Fallopian Tube, andPrimary Peritoneal Cancer

Interventions

A:Adjuvant Chemotherapy of Three-step Regimens (ACTS)

Sponsors

Dept. gynecologic oncology,fudan university shanghai cancer center
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Female patients 18-70 years of age; 2. ECOG 0-2; 3. Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer; 4. FIGO2014 stage IIIC/IV; 5. Patients should have received optimal cytoreductive surgery with residual tumor =9 g/dL White blood cell count >=3.0*10^9/L Absolute neutrophil count >=1.5*10^9/L Platelet count >=100 *10^9/L AST (SGOT)/ALT (SGPT) <=2.5 ULN Bilirubin <1.5*ULN Creatinine <1.5*ULN; 8. Ability andwillingness to give written informed consent.

Exclusion criteria

Exclusion criteria: 1. Primary or secondary immune deficiency; 2. Any uncontrolled medical condition that may put the patient at high risk during treatment; 3. Receipt of any other investigational medicinal product within the last 30 days before randomization; 4. 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; 5. Severe heart/ lung/ liver/ kidney failure; 6. uncontroled or active infection disease; 7. Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons; 8. Receipt of pelvic or abdominal radiotherapy.

Design outcomes

Primary

MeasureTime frame
overall survival;

Secondary

MeasureTime frame
PFS;PFS (CA125);safety;quality of life;

Countries

China

Contacts

Public ContactXiaohua Wu
docwuxh@yahoo.com+86 021-64175590-81007

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026