Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer (HIPECStomach)
調査の概要
詳細な説明
The gastric carcinoma is one of the four most common tumors occurring worldwide. The advanced phase is characterized by metastasis and poses a very poor prognosis for survival. In 20%-30% of gastric carcinomas the tumor spreads into the abdominal cavity, which leads to metastases in the wall of the peritoneal cavity. This is known as peritoneal carcinomatosis and its five-year survival rate is less than 2%. Even after R0 resection of a localized gastric carcinoma the five-year survival rate is only 40%, not least of all because relapses in the form of peritoneal metastases are a common occurrence.
Patients with gastric carcinoma and not yet diagnosed with metastases, but who show free tumor cells in cytology in preoperative laparoscopy before neoadjuvant chemotherapy and gastrectomy, have an 80% risk of developing peritoneal carcinomatosis within one year, which stands in strong contrast to the 40% risk for patients with negative cytology.
In the study presented here (group A) therapeutic hyperthermic intraperitoneal chemoperfusion (HIPEC, in the literature also known as HIIC (heated intraoperative intraperitoneal chemotherapy) or IPHC (intraperitoneal chemohyperthermia)) with mitomycin c and cisplatin will be administered following gastrectomy in patients with a gastric carcinoma with free tumor cells in cytology diagnosed in the preoperative laparoscopy in comparison to (group B) solely gastrectomy in patients with a gastric carcinoma and also with free tumor cells diagnosed in cytology in the preoperative laparoscopy.
A randomization will be performed between group A and B. Patients with gastric carcinoma (TNM Stage ≥ T2<T4) without proven metastases (TNM stage M0), with and without involved regional lymph nodes (TNM stage +N/-N) and positive cytology in preoperative abdominal lavage will be included. Exclusion criteria are extended disease or inoperable tumor.
This study is already permitted by the local ethic commission and the German Federal Institute for Drugs and Medical Devices (BfArM) (EudraCT-Nr.: 2011-004405-25 / Study code: HIPEC_Stomach) and was initiated in August 2012.
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
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-
BW
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Tuebingen、BW、ドイツ、72076
- University of Tuebingen
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Histologically proven gastric adenocarcinoma: uT1,uT2, uT3, Nx, M0
- No prior chemotherapy
- Patients of full age, independent of gender ECOG ≤ 2
- No dissemination of the tumor confirmed by CT of the lung and the abdomen.
- Signed Consent form of the Patient agreeing to investigations
- Leucocytes > 3.000/µl
- Thrombocytes > 100.000/µl
- Creatinine ≤ 1.5mg/dl and or Clearance > 60 ml/min
- informed consent of the patient
- normal ejection-fraction of the heart
Exclusion Criteria:
- Dissemination of the tumor or non-resectable primary tumor
- Malignant secondary disease < 5 years in the past (Exception: in-situ-carcinoma of the cervix and appropriately treated basal cell carcinoma of the skin)
- Patient not of full age
- Inflammatory chronic bowel disease
- Inclusion of the patient in a different study
- Pregnancy or lactation
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：positive cytology with HIPEC
gastric cancer cytology positive with HIPEC Mytomycin and cisplatin intraoperative
|
HIPEC with mytomycin and cisplatin
他の名前：
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|
介入なし：positive cytology without HIPEC
gastric cancer cytology positive without HIPEC
|
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介入なし：negative cytology without HIPEC
gastric cancer with negative cytology
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Peritoneal Carcinosis Free Survival
時間枠：5 Years
|
Three patients were enrolled in the study.
No study results because no patient has received study drug.
|
5 Years
|
|
Disease Free Survival
時間枠：5 years
|
No study results because no patient has received study drug.
|
5 years
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Procedure Related Complication
時間枠：60 days
|
No study results because no patient has received study drug.
|
60 days
|
|
Kinetics of Mitomycin and Cisplatin
時間枠：24 hours after application
|
24 hours after application
|
協力者と研究者
捜査官
- 主任研究者：Alfred Königsrainer, MD、University Hospital Tuebingen
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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