Colorectal Cancer Clinical Trial
— WUHIPEC02Official title:
Comparative Study on the Efficacy of Mitomycin and Lobaplatin in the Treatment of Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with hyperthermic intraperitoneal chemotherapy
Status | Not yet recruiting |
Enrollment | 201 |
Est. completion date | September 1, 2026 |
Est. primary completion date | September 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed; 2. Aged 18-75 years; 3. Male or non-pregnant or lactating women; 4. Pathological diagnosis of colorectal adenocarcinoma; 5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (AJCC Version 8, 2018); 6. Normal function of major organs; 7. Routine blood examinations meeting the following criteria: A. HB = 90 g/L; B. ANC = 1.5 x 10 9 /L; C. PLT = 125 × 10 9 /L; 8. Chemistry indexs meeting the following criteria: A. TBIL < 1.5ULN; B. ALT and AST < 2.5ULN; ALB > 30 g/L C. serum Cr = 1.25 ULN or endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); 9. ECOG score 0-1; Exclusion Criteria: 1. A history of other malignant tumors within 5 years; 2. Distant metastasis found during surgery; 3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs; 4. Suffering from epilepsy or other mental illness, unable to control behavior; 5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease; 6. Pregnant or lactating women. 7. Receiving anti-cancer drug therapy from other clinical trials. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Wuhan Union Hospital, China |
Hompes D, Tiek J, Wolthuis A, Fieuws S, Penninckx F, Van Cutsem E, D'Hoore A. HIPEC in T4a colon cancer: a defendable treatment to improve oncologic outcome? Ann Oncol. 2012 Dec;23(12):3123-3129. doi: 10.1093/annonc/mds173. Epub 2012 Jul 25. — View Citation
Razenberg LG, van Gestel YR, Creemers GJ, Verwaal VJ, Lemmens VE, de Hingh IH. Trends in cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for the treatment of synchronous peritoneal carcinomatosis of colorectal origin in the Netherlands — View Citation
Segelman J, Granath F, Holm T, Machado M, Mahteme H, Martling A. Incidence, prevalence and risk factors for peritoneal carcinomatosis from colorectal cancer. Br J Surg. 2012 May;99(5):699-705. doi: 10.1002/bjs.8679. Epub 2012 Jan 27. — View Citation
Torphy RJ, Stewart C, Sharma P, Halpern AL, Oase K, Herter W, Bartsch C, Friedman C, Del Chiaro M, Schulick RD, Gleisner A, McCarter MD, Ahrendt SA. Dextrose-Containing Carrier Solution for Hyperthermic Intraperitoneal Chemotherapy: Increased Intraoperati — View Citation
Wisselink DD, Braakhuis LLF, Gallo G, van Grevenstein WMU, van Dieren S, Kok NFM, de Reuver PR, Tanis PJ, de Hingh IHJT. Systematic review of published literature on oxaliplatin and mitomycin C as chemotherapeutic agents for hyperthermic intraperitoneal chemotherapy in patients with peritoneal metastases from colorectal cancer. Crit Rev Oncol Hematol. 2019 Oct;142:119-129. doi: 10.1016/j.critrevonc.2019.06.014. Epub 2019 Jul 9. — View Citation
Yan TD, Cao CQ, Munkholm-Larsen S. A pharmacological review on intraperitoneal chemotherapy for peritoneal malignancy. World J Gastrointest Oncol. 2010 Feb 15;2(2):109-16. doi: 10.4251/wjgo.v2.i2.109. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | peritoneal metastasis | peritoneal metastasis-free survival (pRFS) | 3-year | |
Primary | overall survival | overall survival (OS) | 3-year | |
Secondary | Number of participants with immunosuppression events as assessed by blood immunological indicators | Before and After Hyperthermic Intraperitoneal Chemotherapy, collect 5mL blood samples of patients for detecting immunological indicators such as CD3, CD4 and CD8 lymphocyte population; Interferon-?; tumor necrosis factor (TNF)-a; interleukin-2, 4, 8, 10, etc | up to 4 weeks | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | postoperative adverse events (referring to CTCAE 5.0 [including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events]) was analyzed | up to 4 weeks | |
Secondary | The positive rate of cancer cells of participants by exfoliative cytology examination | According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed. | 1 week |
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