Clinical trial NCT04845490: Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Colorectal Cancer
Chemotherapy Effect
Surgery
Metastasis
Survival
Keywords: advanced colorectal cancer
hyperthermic intraperitoneal chemotherapy
mitomycin
lobaplatin
prognosis
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We divide patients into 3 groups randomly. drug group 1: Radical Surgery + HIPEC (mitomycin) + mFOLFOX6/XELOX regimen; drug group 2: Radical Surgery + HIPEC (lobaplatin) + mFOLFOX6/XELOX regimen; control group: Radical Surgery + HIPEC (no drug) + mFOLFOX6/XELOX regimen
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: peritoneal metastasis
timeFrame: 3-year
measure: overall survival
timeFrame: 3-year
Secondary outcomes:
measure: Number of participants with immunosuppression events as assessed by blood immunological indicators
timeFrame: up to 4 weeks
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: up to 4 weeks
measure: The positive rate of cancer cells of participants by exfoliative cytology examination
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Wuhan Union Hospital, China
name: Kaixiong Tao, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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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 Intraoperative Hyperglycemia and Postoperative Complications. Ann Surg Oncol. 2020 Dec;27(13):4874-4882. doi: 10.1245/s10434-020-08330-y. Epub 2020 Apr 19.