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Phase III Trial of Stage I Ovarian Cancer After Surgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04063527
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : August 30, 2019
Korean Gynecologic Oncology Group
Information provided by (Responsible Party):
Japanese Gynecologic Oncology Group

Brief Summary:
To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Drug: adjuvant chemotherapy Phase 3

Detailed Description:

Based on the following adjustment factors, patients will be randomly assigned in a 1:1 ratio to adjuvant chemotherapy or observation groups.

  1. Histologic type: clear cell adenocarcinoma/mucinous adenocarcinoma vs. serous adenocarcinoma/other histologic types
  2. Facility where a subject is enrolled
  3. International Federation of Gynecology and Obstetrics(FIGO) clinical staging: Stage Ia/ Ib vs. Stage Ic(b)

Group A: adjuvant chemotherapy group (standard treatment group):

While one of the following treatments will be performed, the number of cycles is entrusted to the treatment policy of each facility.

Paclitaxel plus Carboplatin (TC) therapy; Paclitaxel (PTX) 175 mg/m2 + Carboplatin(CBDCA) area under curve(AUC) 6 q3weeks day1, 3 to 6 cycles Docetaxel plus Carboplatin (DC) therapy; Docetaxel(DTX) 70 mg/m2 + CBDCA AUC 6 q3weeks day1, 3 to 6 cycles

After the start of TC therapy, switching from PTX to DTX due to an adverse event is permitted.

Group B: observation group (study treatment group): Observation only, no adjuvant chemotherapy administered.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery
Actual Study Start Date : July 20, 2012
Estimated Primary Completion Date : October 1, 2029
Estimated Study Completion Date : February 1, 2030

Arm Intervention/treatment
Active Comparator: Standard therapy
combination of paclitaxel and carboplatin
Drug: adjuvant chemotherapy
combination of paclitaxel and carboplatin
Other Name: paclitaxel and carboplatin

No Intervention: Observation

Primary Outcome Measures :
  1. Overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 60 months ]
    1. In surviving patients, cut off will be on the last date the patient is confirmed to be alive.
    2. If a patient is lost to follow-up, cut off will be on the last date the patient is confirmed to be alive before being lost to follow-up.

Secondary Outcome Measures :
  1. Relapse-free survival [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months ]
    1. If relapse is diagnosed through imaging, it is considered an event on the "test date" on which a "definite diagnosis" is obtained and not the test date that showed a "suspected relapse on an image." If a relapse is clinically diagnosed, not just through imaging, it is considered an event on the date on which relapse is diagnosed.
    2. Progression observed by CA-125 only shall not be handled as an event in this study.

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.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients with a diagnosis of histopathologically epithelial ovarian cancer
  2. 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)
  3. Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
  4. 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] see details below), retroperitoneal lymph node dissection (see details below [Retroperitoneal lymph node dissection]).

    However, for the following cases, it is eligible as a condition to record on the official document.

    • 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.
  5. Age: 20 or older
  6. Performance status (PS):0-1
  7. Case with initial therapy for postoperative primary lesion
  8. Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
  9. Reasonable organ function
  10. Patient must have signed informed consent.

Exclusion Criteria:

  1. FIGO Stages Ic(a), Ic(1) and Ic(2)
  2. Patients containing sarcoma elements
  3. Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography and CT
  4. Patients with serious complications
  5. Patients with active infection
  6. Patients with intestinal paralysis or intestinal obstruction
  7. Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
  8. Patients with previous chemotherapy or radiation therapy
  9. Patients with serious drug hypersensitivity
  10. Patients with peripheral motor/sensory neuropathy [grade2,3,4 Common Terminology Criteria for Adverse Events (CTCAE) 4.0]
  11. Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
  12. 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 anti-hepatitis B surface antigen.
  13. Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

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 identifier (NCT number): NCT04063527

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Contact: Hiroshi Tanabe, M.D. 81-4-7133-1111

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Sponsors and Collaborators
Japanese Gynecologic Oncology Group
Korean Gynecologic Oncology Group
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Study Chair: Hiroshi Tanabe, M.D. National Cancer Center Hospital East

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Responsible Party: Japanese Gynecologic Oncology Group Identifier: NCT04063527    
Other Study ID Numbers: JGOG3020
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Japanese Gynecologic Oncology Group:
epithelial ovarian cancer
FIGO stage I
staging surgery
adjuvant chemotherapy
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action