Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 297 for:    colon cancer AND Capecitabine AND chemotherapy

HIPEC and Systemic Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398512
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bin Xiong, MD, Wuhan University

Brief Summary:
The prognosis of patients with unresectable peritoneal metastases from colorectal cancer is poor. These patients may obtain survival benefit from radical colorectal resection and cytoreductive surgery (CRS). The response rates of previous conversion therapy are low. Hyperthermic intraperitoneal chemoperfusion (HIPEC) and systemic chemotherapy are effective methods of reducing peritoneal cancer index (PCI) levels. The purpose of this study is to investigate the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer.

Condition or disease Intervention/treatment Phase
Peritoneal Metastases From Colorectal Cancer Procedure: exploratory laparoscopy or laparotomy Procedure: HIPEC Drug: Systemic chemotherapy Not Applicable

Detailed Description:
To determine the efficacy and safety of HIPEC and systemic chemotherapy in the conversion therapy of peritoneal metastases from colorectal cancer, patients undergo HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Conversion Therapy Using Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) and Systemic Oxaliplatin/Capecitabine Chemotherapy in Unresectable Peritoneal Metastases From Colorectal Cancer
Estimated Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental
HIPEC with Raltitrexed at the time of fist surgery and twice repeat within one week after the surgery, following 3 cycles of 3-week Oxaliplatin/Capecitabine chemotherapy. The second surgery, exploratory laparoscopy or laparotomy, is carried out one week later after the series of systemic chemotherapy.
Procedure: exploratory laparoscopy or laparotomy
Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery

Procedure: HIPEC
Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.

Drug: Systemic chemotherapy
Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week




Primary Outcome Measures :
  1. radical resection rate [ Time Frame: 3 months ]
    The rate between the number of patients with radically resectable peritoneal metastases and those with unresectable peritoneal metastases


Secondary Outcome Measures :
  1. the Peritoneal Cancer Index score [ Time Frame: 3 months ]
    The score range from 0 to 39, higher values represent a worse outcome

  2. overall survival [ Time Frame: 3 years ]
    The overall survival time

  3. complication rate [ Time Frame: 3 years ]
    The rate of adverse complication



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological proved diagnosis of colorectal cancer.
  • Unresectable peritoneal metastases and primary tumor proved at surgery.
  • No evidence of distant metastases.
  • Have not received radiotherapy, chemotherapy or immunotherapy.
  • ECOG score: 0~2.
  • Written informed consent is obtained prior to commencement of trial treatment.

Exclusion Criteria:

  • Existence of distant metastasis outside the abdomen.
  • Any previous radiotherapy, chemotherapy or immunotherapy.
  • Active systemic infections.
  • Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
  • Female patients who are pregnant or breast feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398512


Contacts
Layout table for location contacts
Contact: Bin Xiong +86 27 67813152 jyn1983@163.com

Locations
Layout table for location information
China, Hubei
Wuhan University Recruiting
Wuhan, Hubei, China
Contact: Bin Xiong    +86 27 67813152    jyn1983@163.com   
Sponsors and Collaborators
Wuhan University

Layout table for additonal information
Responsible Party: Bin Xiong, MD, Zhongnan Hospital, Wuhan University
ClinicalTrials.gov Identifier: NCT03398512     History of Changes
Other Study ID Numbers: WuhanU_Peritoneal M_colon
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Capecitabine
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents