Overview

Adjuvant Chemotherapy of Three-step Regimen in Ovarian Cancer

Status:
Active, not recruiting
Trial end date:
2023-11-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Xiaohua Wu MD
Treatments:
Carboplatin
Cyclophosphamide
Etoposide
Etoposide phosphate
Criteria
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