Phase II/III trial to evaluate the efficacy and safety of intraperitoneal chemotherapy using carboplatin.

JRCT ID: jRCTs031180141

Registered date:20/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: ovarian cancer, fallopian tube cancer, peritoneal cancer
• Date of first enrollment: 22/07/2010
• Target sample size: 655
• Countries of recruitment: USA,Japan,Singapore,Japan,Korea,Japan,Hong Kong,Japan,New Zealand,Japan
• Study type: Interventional
• Intervention(s): randomized assignment

Outcome(s)

• Primary Outcome: Progression-free survival

Secondary Outcome

Overall Survival
Safety (Toxicity)
QOL
Cost Effectiveness

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1) Patients assumed to have a stage II-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
2) Patients scheduled to undergo laparotomy (or laparoscopic exploratory surgery)
3) ECOG Performance Status: 0-2
4) Patients who provide consent for placement of the IP port system
5) Patients expected to receive the first protocol treatment within 8 weeks after the comprehensive staging surgery
6) Lab data and clinical examination indicate normal organ function
7) Patients expected to survive longer than 3 months from the start date of the protocol treatment
8) Patients aged 20 years and older at the time of tentative registration (with no upper age limit)
9) Patients who provide written informed consent for participation in this trial

Exclude criteria

1) Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary
peritoneal cancer
2) Patients who have received previous chemotherapy or radiation therapy to treat the current
disease
3) Patients who have a synchronous malignancy or who have been progression-free less than 5
years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the
skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are
eligible for the study)
4) Patients with serious medical complications, such as serious heart disease, cerebrovascular
accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis,
interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious
neurological disorder
5) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor
oil
6) Patients with a pleural effusion requiring continuous drainage
7) Patients with an active infection requiring antibiotics
8) Patients who are pregnant, nursing or of child-bearing potential
9) Patients with evidence upon physical examination of brain tumor and any brain metastases
10) Patients for whom completion of this study and/or follow-up is deemed inappropriate for any
reason
11) Patients with any signs/symptoms of interstitial pneumonia

Related Information

• Primary Sponsor: Fujiwara Keiichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Gynecologic Oncology Trial and Investigation Consortium,Japanese Gynecologic Oncology Group
• Secondary ID(s): UMIN000003670, NCT01506856