BridgeMD
New treatment option for Epithelial Ovarian Cancer
Official title Phase III Trial of Stage I Ovarian Cancer After Surgery
ClinicalTrials.gov ID: NCT04063527
What this study is testing
What is adjuvant chemotherapy?
adjuvant chemotherapy is an investigational medicine, being studied as a potential treatment for epithelial ovarian cancer.
Also referred to as paclitaxel and carboplatin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older, women only
You may be able to join if
- Patients with a diagnosis of histopathologically epithelial ovarian cancer
- FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type)
- Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
- Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy)...
- Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been...
You likely can't join if
- FIGO Stages Ic(a), Ic(1) and Ic(2)
- Patients containing sarcoma elements
- Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
- Patients with serious complications
- Patients with active infection
- Patients with intestinal paralysis or intestinal obstruction
See the full eligibility criteria
- Patients with a diagnosis of histopathologically epithelial ovarian cancer
- FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type)
- Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
- Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum...
- Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed.
- Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached.
- Age: 20 or older
- Performance status (PS):0-1
- Case with initial therapy for postoperative primary lesion
- Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
- Reasonable organ function
- Patient must have signed informed consent.
- FIGO Stages Ic(a), Ic(1) and Ic(2)
- Patients containing sarcoma elements
- Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
- Patients with serious complications
- Patients with active infection
- Patients with intestinal paralysis or intestinal obstruction
- Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
- Patients with previous chemotherapy or radiation therapy
- Patients with serious drug hypersensitivity
- Patients with peripheral motor/sensory neuropathy [grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0]
- Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
- Patients with positive HBsAg. Patients with more than 2.1 log/copies ml based on fixed Hepatitis B virus (HBV)-DNA who are positive with either antigen-positive Hepatitis B (HBs), anti-hepatitis B core antigen or...
- Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
The study team makes the final eligibility decision.
Where it's taking place
- Nagakute-shi, Aichi-ken, Japan
- Seto-shi, Aichi-ken, Japan
- Toyoake-shi, Aichi-ken, Japan
- Hirosaki-shi, Aomori, Japan
- Kashiwa-shi, Chiba, Japan
- Onsen-gun, Ehime, Japan
- Fukuoka, Fukuoka, Japan
- Kurume-shi, Fukuoka, Japan
- Gifu, Gifu, Japan
- Maebashi, Gunma, Japan
- Ōta, Gunma, Japan
- Hatsukaichi-shi, Hiroshima, Japan
- Hiroshima, Hiroshima, Japan
- Miyoshi-shi, Hiroshima, Japan
- Hakodate-shi, Hokkaido, Japan
- Sapporo, Hokkaido, Japan
- Akashi-shi, Hyōgo, Japan
- Amagasaki-shi, Hyōgo, Japan
- Himeji-shi, Hyōgo, Japan
- Tsukuba, Ibaraki, Japan
+ 66 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nagakute-shi, Aichi-ken, Japan; Seto-shi, Aichi-ken, Japan; Toyoake-shi, Aichi-ken, Japan; Hirosaki-shi, Aomori, Japan; Kashiwa-shi, Chiba, Japan; Onsen-gun, Ehime, Japan and 80 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.