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

NCT04845490 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: UHCT-IEC-SOP-016-21-02
• Study Type: interventional
• Target: 201
• Locations: 0 countries
• Sites: N/A

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

Conditions

Colorectal Cancer; Chemotherapy Effect; Surgery; Metastasis; Survival

Keywords

advanced colorectal cancer; hyperthermic intraperitoneal chemotherapy; mitomycin; lobaplatin; prognosis

Outcome Measures

Primary Outcomes (2)

• peritoneal metastasis

  peritoneal metastasis-free survival (pRFS)

  3-year

• overall survival

  overall survival (OS)

  3-year

Secondary Outcomes (3)

• Number of participants with immunosuppression events as assessed by blood immunological indicators

  up to 4 weeks

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

  up to 4 weeks

• The positive rate of cancer cells of participants by exfoliative cytology examination

  1 week

Study Arms (3)

Drug group 1

EXPERIMENTAL

hyperthermic intraperitoneal chemotherapy (HIPEC) (with Mitomycin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Drug: Mitomycin

Drug group 2

EXPERIMENTAL

hyperthermic intraperitoneal chemotherapy (HIPEC) (with lobaplatin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Drug: Lobaplatin

Control group

NO INTERVENTION

hyperthermic intraperitoneal therapy (HIPET) (no drug) : Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: no drug. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Interventions

Mitomycin DRUG

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).

Drug group 1

Lobaplatin DRUG

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).

Drug group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
• Aged 18-75 years;
• Male or non-pregnant or lactating women;
• Pathological diagnosis of colorectal adenocarcinoma;
• Clinical diagnosis of T3 stage or above without distant metastasis and can be given radical surgery (AJCC Version 8, 2018);
• Normal function of major organs;
• 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;
• 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);
• ECOG score 0-1;

You may not qualify if:

• A history of other malignant tumors within 5 years;
• Distant metastasis found during surgery;
• Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
• Suffering from epilepsy or other mental illness, unable to control behavior;
• Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
• Pregnant or lactating women.
• Receiving anti-cancer drug therapy from other clinical trials.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Related Publications (6)

• 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.

  PMID: 31400583 BACKGROUND

• 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.

  PMID: 21160929 BACKGROUND

• 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.

  PMID: 22831982 RESULT

• 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.

  PMID: 22287157 RESULT

• 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. Eur J Surg Oncol. 2015 Apr;41(4):466-71. doi: 10.1016/j.ejso.2015.01.018. Epub 2015 Jan 29.

  PMID: 25680955 RESULT

• 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.

  PMID: 32306237 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Mitomycin; lobaplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Kaixiong Tao, Professor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaixiong Tao, Professor

CONTACT

+86- 027-85351662; kaixiongtao@hust.edu.cn

Cuanqing Wu, Doctor

CONTACT

+86-13995598966; linyaomt@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the choice of HIPEC drugs is unknown to patients with advanced colorectal cancer, but known to doctors, investigators and outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 15, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 21, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: we would like to share IPD to other researchers 1 years after clinical trial finished
• Access Criteria: all data should not been used for commercial purpose and other private purpose and only for academic research