Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjuvant Chemotherapy of Three-step Regimen in Ovarian Cancer (ACTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02562365
Recruitment Status : Active, not recruiting
First Posted : September 29, 2015
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaohua Wu MD, Fudan University

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Etoposide, Cyclophosphamide, Carboplatin Phase 2

Detailed Description:

More than 70 percent of ovarian cancer patients were diagnosed in the advanced stage. Currently the 5-year disease free survival (DFS) of stageⅢC-Ⅳovarian cancer patients was about 10 percent after first line chemotherapy. Dr Cai shumo developed adjuvant chemotherapy of "three steps" (ACTS) for advanced ovarian cancer after cytoreductive surgery, based on his 60+ years experience on gynecologic oncology. After the first step 6-8 cycle paclitaxel plus carboplatin chemotherapy, the chemo-sensative cancer cells were killed, but resistant/dormancy cell remained. The second step chemotherapy which is 6 cycle CTX+VP-16 every 4weeks, using different mechanism to kill cancer cells, may decrease the rate of recurrence within 6 month after first step chemotherapy, prolong platinum-free duration and also with acceptable side effects. After second step chemotherapy, in absence of 6 months platinum treatment, the previous G0 dormancy cell may become flexible to platinum treatment. Therefore, in the third step chemotherapy, CTX+CBP is used in every 8 week for 6 cycles. Comparing to using targeted therapy for maintaining therapy, the ACTS cost less.

In the previous observation study(CHINA ONCOLOGY 2013 Vol.23 No.12 p980), In study arm A, the patients received three-step chemotherapy after primary debulking surgery, step one with paclitaxel plus carboplatin (TC regimen), every 3 weeks for 6 to 8 cycles; step two with etoposide plus cyclophosphamide, every 4 weeks for 6 cycles; step three with carboplatin plus cyclophosphamide every eight weeks for six cycles. In control arm B, investigators retrospectively analysed 51 cases withⅢC-Ⅳstage ovarian cancer, who had completely response after standard chemotherapy with six to eight cycles of TC after primary surgery during 2007. Investigators compared the 5-year DFS between the two arms. Results: The 5-year DFS of 15 cases in arm A was 80%(12/15), which was signiifcantly higher than that of arm B (5.9%, 3/51, P<0.01). Therefore we start this randomized open control clinic trial to evaluated the effect of ACTS on overall survival and its safety.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2015
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2023


Arm Intervention/treatment
Experimental: A: three steps chemotherapy
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
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
Other Name: VP-16,CTX,CBP

No Intervention: B: Follow-up
No interevention



Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]

Secondary Outcome Measures :
  1. Progression-Free-Survival [ Time Frame: 5 year ]
  2. Health-related quality of life [ Time Frame: 5 year ]
    FACT-O 4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562365


Locations
Layout table for location information
China, Shanghai
Wu Xiaohua
Shanghai, Shanghai, China, 200023
Sponsors and Collaborators
Xiaohua Wu MD
Investigators
Layout table for investigator information
Principal Investigator: Xiaohua WU, PhD & MD Fudan university shanghai cancer center, Deparment of gynecologic oncology
Layout table for additonal information
Responsible Party: Xiaohua Wu MD, Fudan University Shanghai cancer center, Fudan University
ClinicalTrials.gov Identifier: NCT02562365    
Other Study ID Numbers: FUSCC-OC1501
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Keywords provided by Xiaohua Wu MD, Fudan University:
adjuvent chemotherapy
ovarian cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclophosphamide
Carboplatin
Etoposide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors