Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis (IPHC)
Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial
OBJECTIVES:
- Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery.
All patients in both groups receive the standard conventional chemotherapy after surgery.
Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.
調査の概要
状態
詳細な説明
DISEASE CHARACTERISTICS:
- Histologically confirmed peritoneal carcinomatosis with the following histologies:
- Primary peritoneal mesothelioma
- Adenocarcinoma of gastrointestinal tract origin
- Confined to peritoneal cavity
- Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit
- Must not have failed prior intraperitoneal platinum therapy
- Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy
PATIENT CHARACTERISTICS:
Age:
- 20 to 70 years old
Performance status:
- KPS>50
Life expectancy:
- More than 8 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 80,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT no greater than 2 times ULN
- Liver enzymes no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No significant irreversible cardiac ischemia
- No significant changes in ECG recording
Pulmonary:
- FEV_1 at least 1.2 liters
- Maximum voluntary ventilation at least 50% expected
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent medical problems that would preclude surgery
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Hubei
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Wuhan、Hubei、中国、430071
- 募集
- Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
-
コンタクト:
- Yan Li, M.D., Ph.D
- 電話番号:3152 +86-27-67813152
- メール:liyansd2@163.com
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コンタクト:
- Yonemura Yutaka, M.D., Ph.D
- 電話番号:+81-072-433-2131
- メール:y.yonemura@coda.ocn.ne.jp
-
副調査官:
- Guo-Liang Yang, M.D
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副調査官:
- Fu-Lin Cheng, M.D.
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主任研究者:
- Yan Li, M.D., Ph.D
-
副調査官:
- Mao-Hui Feng, M.D., Ph.D
-
副調査官:
- Shibo Masaya, M.D.
-
-
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:
- Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- Gastric cancer or colorectal cancer with malignant ascites
- Karnofsky Performance Scale(KPS)>50
Exclusion Criteria:
- Age less than 20 years old, or beyond 70 years old
- Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis
- Bilirubin greater than 3 times upper limit of normal (ULN)
- AST and ALT greater than 5 times ULN
- Liver enzymes greater than 3 times ULN
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:A
cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy.
|
Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.
他の名前:
|
アクティブコンパレータ:B
cytoreductive surgery alone, postoperative chemotherapy.
|
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
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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 |
時間枠 |
---|---|
overall survival time
時間枠:from operation to death due to cancer recurrence
|
from operation to death due to cancer recurrence
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
perioperative morbidity and mortality
時間枠:Within 30 days postoperation
|
Within 30 days postoperation
|
協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Yan Li, M.D., Ph.D、Cancer Center of Wuhan University
- 主任研究者:Yonemura Yutaka, MD, PhD、NPO Organization to Support Peritoneal Dissemination Treatment
出版物と役立つリンク
一般刊行物
- Yang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19.
- Wu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
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 (見積もり)
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
本研究に関する用語
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