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Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy (WUHIPEC02)

Primary Purpose

Colorectal Cancer, Chemotherapy Effect, Surgery

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Mitomycin

Lobaplatin

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring advanced colorectal cancer, hyperthermic intraperitoneal chemotherapy, mitomycin, lobaplatin, prognosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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;

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Drug group 1

Drug group 2

Control group

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

peritoneal metastasis

peritoneal metastasis-free survival (pRFS)

overall survival

overall survival (OS)

Secondary Outcome Measures

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-γ; tumor necrosis factor (TNF)-α; interleukin-2, 4, 8, 10, etc

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

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.

Full Information

NCT ID

NCT04845490

First Posted

April 6, 2021

Last Updated

February 18, 2022

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04845490

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

September 1, 2023 (Anticipated)

Study Completion Date

September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Chemotherapy Effect, Surgery, Metastasis, Survival

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

Masking

Participant

Masking Description

the choice of HIPEC drugs is unknown to patients with advanced colorectal cancer, but known to doctors, investigators and outcomes assessors.

Allocation

Randomized

Enrollment

201 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug group 1

Arm Type

Experimental

Arm Description

Arm Title

Drug group 2

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Mitomycin

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Lobaplatin

Intervention Description

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).

Primary Outcome Measure Information:

Title

peritoneal metastasis

Description

peritoneal metastasis-free survival (pRFS)

Time Frame

3-year

Title

overall survival

Description

overall survival (OS)

Time Frame

3-year

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

up to 4 weeks

Title

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

Description

postoperative adverse events (referring to CTCAE 5.0 [including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events]) was analyzed

Time Frame

up to 4 weeks

Title

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

Description

According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed.

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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; Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kaixiong Tao, Professor

Phone

+86- 027-85351662

kaixiongtao@hust.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Cuanqing Wu, Doctor

Phone

+86-13995598966

linyaomt@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaixiong Tao, Professor

Organizational Affiliation

Wuhan Union Hospital, China

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

we would like to share IPD to other researchers 1 years after clinical trial finished

IPD Sharing Time Frame

we would like to share IPD to other researchers 1 years after clinical trial finished

IPD Sharing Access Criteria

all data should not been used for commercial purpose and other private purpose and only for academic research

Citations:

PubMed Identifier

31400583

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.

Results Reference

background

PubMed Identifier

21160929

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.

Results Reference

background

PubMed Identifier

22831982

Citation

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.

Results Reference

result

PubMed Identifier

22287157

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.

Results Reference

result

PubMed Identifier

25680955

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

Results Reference

result

PubMed Identifier

32306237

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.

Results Reference

result

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

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