小児および成人の胚細胞腫瘍患者に対する積極的監視、ブレオマイシン、エトポシド、カルボプラチンまたはシスプラチンによる治療

基本情報

NCT ID: NCT03067181
ステータス: 募集中
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 1,780
治験依頼者名: Children's Oncology Group

概要

This phase III trial studies how well active surveillance help doctors to monitor subjects with low risk germ cell tumors for recurrence after their tumor is removed. When the germ cell tumor has spread outside of the organ in which it developed, it is considered metastatic. Chemotherapy drugs, such as bleomycin, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The trial studies whether carboplatin or cisplatin is the preferred chemotherapy to use in treating metastatic standard risk germ cell tumors.

対象疾患

Childhood Extracranial Germ Cell TumorExtragonadal Embryonal CarcinomaGerm Cell TumorMalignant Germ Cell TumorMalignant Ovarian TeratomaStage I Ovarian ChoriocarcinomaStage I Ovarian Embryonal Carcinoma AJCC v6 and v7Stage I Ovarian Yolk Sac Tumor AJCC v6 and v7Stage I Testicular Choriocarcinoma AJCC v6 and v7Stage I Testicular Embryonal Carcinoma AJCC v6 and v7Stage I Testicular Seminoma AJCC v6 and v7Stage I Testicular Yolk Sac Tumor AJCC v6 and v7Stage II Ovarian ChoriocarcinomaStage II Ovarian Embryonal Carcinoma AJCC v6 and v7Stage II Ovarian Yolk Sac Tumor AJCC v6 and v7Stage II Testicular Choriocarcinoma AJCC v6 and v7Stage II Testicular Embryonal Carcinoma AJCC v6 and v7Stage II Testicular Yolk Sac Tumor AJCC v6 and v7Stage III Ovarian ChoriocarcinomaStage III Ovarian Embryonal Carcinoma AJCC v6 and v7Stage III Ovarian Yolk Sac Tumor AJCC v6 and v7Stage III Testicular Choriocarcinoma AJCC v6 and v7Stage III Testicular Embryonal Carcinoma AJCC v6 and v7Stage III Testicular Yolk Sac Tumor AJCC v6 and v7Stage IV Ovarian ChoriocarcinomaStage IV Ovarian Embryonal Carcinoma AJCC v6 and v7Stage IV Ovarian Yolk Sac Tumor AJCC v6 and v7Testicular Mixed Choriocarcinoma and Embryonal CarcinomaTesticular Mixed Choriocarcinoma and TeratomaTesticular Mixed Choriocarcinoma and Yolk Sac Tumor

介入

Computed Tomography(PROCEDURE)

Best Practice(OTHER)

Biopsy Procedure(PROCEDURE)

Biospecimen Collection(PROCEDURE)

Bleomycin Sulfate(BIOLOGICAL)

Carboplatin(DRUG)

Cisplatin(DRUG)

Etoposide(DRUG)

Magnetic Resonance Imaging(PROCEDURE)

Pharmacogenomic Study(OTHER)

Pulmonary Function Test(PROCEDURE)

Quality-of-Life Assessment(OTHER)

Questionnaire Administration(OTHER)

依頼者（Sponsor）

National Cancer Institute (Nci)(NIH)

Children's Oncology Group(NETWORK)

実施施設 (17)

Kyushu Univeristy

Higashiku, Fukuoka, Japan(RECRUITING)

兵庫県立こども病院

Kobe, Hyōgo, Japan(RECRUITING)

東北大学病院

Sendai, Aoba-ku, Japan(RECRUITING)

筑波大学附属病院

Tsukuba, Ibaraki, Japan(RECRUITING)

神奈川県立こども医療センター

Yokohama, Kanagawa, Japan(RECRUITING)

兵庫医科大学病院

Nishinomiya, Hyogo, Japan(SUSPENDED)

新潟県立がんセンター新潟病院

Niigata, Chuo-ku, Japan(RECRUITING)

京都府立医科大学附属病院

Kyoto, Japan(RECRUITING)

埼玉県立小児医療センター

Chuo-ku, Saitama, Japan(RECRUITING)

大阪市立総合医療センター

Osaka, Japan(RECRUITING)

広島大学病院

Hiroshima, Japan(RECRUITING)

慶應義塾大学病院

Shinjuku-ku, Tokyo, Japan(RECRUITING)

Kokuritsu Seiiku Medical Research Center Hospital

Tokyo, Japan(RECRUITING)

国立研究開発法人国立がん研究センター中央病院

Tokyo, Japan(RECRUITING)

北海道大学病院

Sapporo, Hokkaido, Japan(RECRUITING)

千葉大学医学部附属病院

Chiba-sgi, Chiba, Japan(RECRUITING)

埼玉医科大学国際医療センター

Saitama, Japan(RECRUITING)