Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Colorectal Cancer Clinical Trial

— WUHIPEC02  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04845490
• Other study ID #: UHCT-IEC-SOP-016-21-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: September 1, 2026

Study information

• Verified date: April 2021
• Source: Wuhan Union Hospital, China
• Contact: Kaixiong Tao, Professor
• Phone: +86- 027-85351662
• Email: kaixiongtao[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been more than 20 years for CRS + HIPEC applying in treatment of patients with colorectal cancer peritoneal metastasis. While, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion for local advanced colorectal cancer patients. Thus, This study aim to compare the efficacy of Mitomycin and Lobaplatin in the treatment of advanced colorectal cancer patients with radical surgery combined with HIPEC. We plan to recruit 201 patients and divide into 3 groups, 2 drug groups and 1 control group, radomly. all patients with advanced co cancer receive radical surgery + HIPEC + mFOLFOX6/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Mitomycin, Lobaplatin and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Colorectal Cancer
• Colorectal Neoplasms
• Fever
• Hyperthermia
• Metastasis
• Surgery
• Survival

Intervention

Drug:
• Mitomycin
Mitomycin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
• Lobaplatin
Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Lobaplatin 50mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

References & Publications (6)

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

Outcome

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