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Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis

Primary Purpose

Rectal Neoplasm With Metastasis to the Liver

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
simultaneous resection of liver metastasis and the rectal primary tumor
staged resection of liver metastasis and the rectal primary tumor
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Neoplasm With Metastasis to the Liver focused on measuring rectal neoplasms, liver metastasis, surgery, simultaneous resection, staged resection

Eligibility Criteria

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

Inclusion Criteria:

  • age>=18 and <= 75 years
  • resectable primary rectal tumor
  • remnant liver volume >= 60%
  • without other organ metastasis or peritoneum metastasis
  • without contradiction of cardiac and pulmonary diseases
  • American Society of Anesthesiologists (ASA) class I - II
  • Histologically proved rectal adenocarcinoma

Exclusion Criteria:

  • age > 75 years
  • unresectable primary rectal tumor
  • remnant liver volume < 60%
  • with other organ metastasis or peritoneum metastasis
  • with contradiction of cardiac and pulmonary diseases
  • Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy
  • Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
  • Multiple colorectal tumors or other schedules needing for synchronous colon surgery
  • Co-existent inflammatory bowel disease
  • Pregnancy or lactation
  • Patients received treatment other than preoperative radio- or chemoradiotherapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    simultaneous resection of liver metastasis and the rectal primary tumor

    staged resection of the liver metastasis and the rectal primary tumor

    Outcomes

    Primary Outcome Measures

    Severe complication rate after resection of primary and metastatic lesions
    Grade of III-V complication rate according to Clavien-Dindo

    Secondary Outcome Measures

    Disease free survival
    Disease free survival after the last resection of primary and metastatic lesions
    Overall survival
    Overall survival after the last resection of primary and metastatic lesions
    Post-operative mortality
    any death occured within 90 days after the last resection of primary and metastatic lesions
    Cost of hospitalization
    any cost during the resection of primary and metastatic lesions
    Complication rate after resection of primary and metastatic lesions
    All grade of complication rate according to Clavien-Dindo
    Postoperative hospital stay
    The postoperative hospital stay is defined as the number of date from the first day after operation to discharge

    Full Information

    First Posted
    May 12, 2008
    Last Updated
    July 2, 2022
    Sponsor
    Fudan University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00677586
    Brief Title
    Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis
    Official Title
    Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2010 (Actual)
    Primary Completion Date
    December 31, 2020 (Actual)
    Study Completion Date
    July 1, 2022 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to investigate the safety and efficacy of simultaneous liver resections compared to staged hepatectomies of rectal cancer with liver metastasis and to compare the short and long-term survival between the two groups.
    Detailed Description
    The optimal surgical strategy for treatment of patients with resectable synchronous rectal liver metastases remains controversial. To answer whether synchronous rectal cancer liver metastases (SLM) should be resected simultaneously with primary cancer or should be delayed, We conducted a randomized, controlled trial to compare the safety and efficacy of simultaneous versus delayed resection of the rectum and liver. Patients with rectal cancer and resectable SLM were randomly assigned to either simultaneous or delayed resection of the metastases. The primary outcome was the rate of major complications (Clavien-Dindo grade≥III) within 30 days following surgery. Secondary outcomes included disease-free and overall survival. A consecutive patients of rectal cancer with liver metastasis from ZhongShan hospital, Fudan university were enrolled and randomly assigned to simultaneous liver resections and staged hepatectomies. Post-operative complications, peri-operative mortality, long-term survival were compared.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Neoplasm With Metastasis to the Liver
    Keywords
    rectal neoplasms, liver metastasis, surgery, simultaneous resection, staged resection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Rectal cancer patients with synchronous resectable liver metastasis were randomized to simultaneous resection of primary and metastatic lesions or staged resection
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    simultaneous resection of liver metastasis and the rectal primary tumor
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    staged resection of the liver metastasis and the rectal primary tumor
    Intervention Type
    Procedure
    Intervention Name(s)
    simultaneous resection of liver metastasis and the rectal primary tumor
    Intervention Description
    simultaneous resection of liver metastasis and the rectal primary tumor
    Intervention Type
    Procedure
    Intervention Name(s)
    staged resection of liver metastasis and the rectal primary tumor
    Intervention Description
    Patients received resection of the rectal tumor. 1 months later received resection of liver metastasis
    Primary Outcome Measure Information:
    Title
    Severe complication rate after resection of primary and metastatic lesions
    Description
    Grade of III-V complication rate according to Clavien-Dindo
    Time Frame
    30 days after surgery
    Secondary Outcome Measure Information:
    Title
    Disease free survival
    Description
    Disease free survival after the last resection of primary and metastatic lesions
    Time Frame
    3 years
    Title
    Overall survival
    Description
    Overall survival after the last resection of primary and metastatic lesions
    Time Frame
    3 years
    Title
    Post-operative mortality
    Description
    any death occured within 90 days after the last resection of primary and metastatic lesions
    Time Frame
    90 days after surgery
    Title
    Cost of hospitalization
    Description
    any cost during the resection of primary and metastatic lesions
    Time Frame
    2 months
    Title
    Complication rate after resection of primary and metastatic lesions
    Description
    All grade of complication rate according to Clavien-Dindo
    Time Frame
    30 days after surgery
    Title
    Postoperative hospital stay
    Description
    The postoperative hospital stay is defined as the number of date from the first day after operation to discharge
    Time Frame
    30 days after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age>=18 and <= 75 years resectable primary rectal tumor remnant liver volume >= 60% without other organ metastasis or peritoneum metastasis without contradiction of cardiac and pulmonary diseases American Society of Anesthesiologists (ASA) class I - II Histologically proved rectal adenocarcinoma Exclusion Criteria: age > 75 years unresectable primary rectal tumor remnant liver volume < 60% with other organ metastasis or peritoneum metastasis with contradiction of cardiac and pulmonary diseases Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery Multiple colorectal tumors or other schedules needing for synchronous colon surgery Co-existent inflammatory bowel disease Pregnancy or lactation Patients received treatment other than preoperative radio- or chemoradiotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    jianmin xu, MD, PHD
    Organizational Affiliation
    department of general surgery, zhongshan hospital, fudan university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Simultaneous Versus Staged Resection for Initially Resectable Synchronous Rectal Cancer Liver-limited Metastasis

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