Phase III Trial of Stage I Ovarian Cancer After Surgery

Official title

Randomized Phase III Trial of the Need for Adjuvant Chemotherapy in Stage I Epithelial Ovarian Cancer After Comprehensive Staging Surgery

Overview

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

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.

Interventions

• Drug adjuvant chemotherapy
  combination of paclitaxel and carboplatin

Primary outcome measures

• Overall survival [Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months]

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]

Eligibility criteria

Inclusion 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 (\[Peritoneal biopsy\] 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.
• 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.

Exclusion criteria

• 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 anti-hepatitis B surface antigen.
• Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 98 centers

• Aichi Medical University Hospital — Nagakute-shi
• Tosei General Hospital — Seto-shi
• Fujita Health University Hospital — Toyoake-shi
• Hirosaki University School of Medicine & Hospital — Hirosaki-shi
• The Jikei University School of Medicine Kashiwa Hospital — Kashiwa-shi
• National Cancer Center Hospital East — Kashiwa-shi
• Ehime University Hospital — Onsen-gun
• Kyusyu Medical Center — Fukuoka
• … and 90 more centers

South Korea · 5 centers

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT04063527 · JGOG3020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗