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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.
Studie Overzicht
Toestand
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
-
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Hubei
-
Wuhan, Hubei, China, 430071
- Werving
- Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
-
Contact:
- Yan Li, M.D., Ph.D
- Telefoonnummer: 3152 +86-27-67813152
- E-mail: liyansd2@163.com
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Contact:
- Yonemura Yutaka, M.D., Ph.D
- Telefoonnummer: +81-072-433-2131
- E-mail: y.yonemura@coda.ocn.ne.jp
-
Onderonderzoeker:
- Guo-Liang Yang, M.D
-
Onderonderzoeker:
- Fu-Lin Cheng, M.D.
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Hoofdonderzoeker:
- Yan Li, M.D., Ph.D
-
Onderonderzoeker:
- Mao-Hui Feng, M.D., Ph.D
-
Onderonderzoeker:
- Shibo Masaya, M.D.
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
Andere namen:
|
Actieve vergelijker: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
overall survival time
Tijdsspanne: from operation to death due to cancer recurrence
|
from operation to death due to cancer recurrence
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
perioperative morbidity and mortality
Tijdsspanne: Within 30 days postoperation
|
Within 30 days postoperation
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Yan Li, M.D., Ph.D, Cancer Center of Wuhan University
- Hoofdonderzoeker: Yonemura Yutaka, MD, PhD, NPO Organization to Support Peritoneal Dissemination Treatment
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Pathologische processen
- Neoplasmata per histologisch type
- Neoplasmata per site
- Neoplasmata, glandulair en epitheel
- Peritoneale ziekten
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Maag Ziekten
- Colon Ziekten
- Darmziekten
- Intestinale neoplasmata
- Rectale ziekten
- Neoplastische processen
- Abdominale neoplasmata
- Adenoom
- Neoplasmata, mesotheliaal
- Neoplasmata
- Maagneoplasmata
- Carcinoom
- Colorectale neoplasmata
- Neoplasma metastase
- Peritoneale neoplasmata
- Mesothelioom
- Moleculaire mechanismen van farmacologische werking
- Nucleïnezuursyntheseremmers
- Enzymremmers
- Antineoplastische middelen
- Alkyleringsmiddelen
- Antibiotica, antineoplastiek
- Cisplatine
- Mitomycinen
- Mitomycine
Andere studie-ID-nummers
- WUCC-0701
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