NCT04520074RecruitingPhase 3
Adjuvant Chemotherapy of Three-step Regimen in BRCA1/2 Wide Type Ovarian Cancer (ACTS-2)
A Phase III,Randomized, Multi-center, Open Label Study of Adjuvant Chemotherapy of Three-step Regimens (ACTS) in BRCA1/2 Wide-type Stage III and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
Source: ClinicalTrials.gov · Last updated 27 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 590 (estimated)
- First submitted
- 18 Aug 2020
- Start date
- 8 Oct 2021
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Fudan University
- Diseases
- Ovarian cancer
- NCT number
- NCT04520074
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 590
- From 8 Oct 2021 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
- Receipt of pelvic or abdominal radiotherapy
Other illness
- Any uncontrolled medical condition that may put the patient at high risk during treatment .
- Severe heart/ lung/ liver/ kidney failure.
- uncontroled or active infection disease.
Other
- Primary or secondary immune deficiency.
- Legal incompetence, limited legal competence, or detainment in an institution for official or legal reasons.
- Mucinous adenocarcinoma, low grade carcinoma
Who the study is looking for
- 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.
- Tumor BRCA1/2 wilde type (qualified center test)
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wu Xiaohua Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.