Phase III Trial of Stage I Ovarian Cancer After Surgery

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат adjuvant chemotherapy
  combination of paclitaxel and carboplatin

Первичные конечные точки

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

Вторичные конечные точки (1)

• Relapse-free survival [Срок оценки: 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]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Япония · 98 центров

• 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
• … и ещё 90 центров

South Korea · 5 центров

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT04063527 · JGOG3020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗