Back to resultsCRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC
Primary Purpose
Colorectal Cancer, Retroperitoneal Lymph Node Metastasis, Para-aortic Lymph Node Metastasis
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
lymphadenectomy
chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Chemoradiotherapy, retroperitoneal lymphadenectomy, IMRT, SBRT
Eligibility Criteria
Inclusion Criteria:
- A medical history of colorectal cancer
- Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins.
- The treatment target is no evidence of disease (NED), including 3 cohorts:
A. Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED)
- ECOG PS 0-2
- Ability to follow the program during the study period
- Signing written informed consent
Exclusion Criteria:
- Retroperitoneal LN metastasis is above the level of the renal vein.
- Unable to reach NED.
- Previous pelvic radiotherapy, the field of irradiation overlaps with this time.
- Pregnancy or breastfeeding women.
- Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
- If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
- Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months
- Organ transplantation requires immunosuppressive therapy
- Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
- Subjects Blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets ≥ 100 × 109 / L; ALT, AST≤2.5 times normal upper limit; ALP≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum creatinine <1 times normal upper limit; serum albumin ≥30g/L
Sites / Locations
- Cancer Hospital, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
radical surgery
radical chemoradiotherapy
Arm Description
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
Outcomes
Primary Outcome Measures
Progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.
Secondary Outcome Measures
overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.
local control rate
no recurrence of the retroperitoneal or paraaortic lymph node region.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03725254
Brief Title
CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC
Official Title
Curative Chemoradiotherapy Versus Radical Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2018 (Actual)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to compare the effects of chemoradiation versus radical surgery in treating retro-peritoneal or para-aortic lymph node metastasis in colorectal cancer. By prolonging patients' progression-free survival, local control rate and overall survival, investigators can conclude the best regimen for colorectal cancer patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Retroperitoneal Lymph Node Metastasis, Para-aortic Lymph Node Metastasis
Keywords
Chemoradiotherapy, retroperitoneal lymphadenectomy, IMRT, SBRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
radical surgery
Arm Type
Active Comparator
Arm Description
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.
Arm Title
radical chemoradiotherapy
Arm Type
Experimental
Arm Description
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
Intervention Type
Procedure
Intervention Name(s)
lymphadenectomy
Intervention Description
The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.
Intervention Type
Radiation
Intervention Name(s)
chemoradiotherapy
Intervention Description
Radiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT).
Primary Outcome Measure Information:
Title
Progression-free survival
Description
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works. Also called PFS.
Time Frame
From date of randomization until the date of disease progressed for any reason, assessed up to 5 years
Secondary Outcome Measure Information:
Title
overall survival
Description
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works. Also called OS.
Time Frame
From date of randomization until the date of death from any cause, assessed up to 5 years
Title
local control rate
Description
no recurrence of the retroperitoneal or paraaortic lymph node region.
Time Frame
From date of randomization until the date of disease recurrece, assessed up to 5 years
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:
A medical history of colorectal cancer
Pathological or clinical diagnosis of retroperitoneal/para-vascular lymph node metastases, and located below the level of renal veins.
The treatment target is no evidence of disease (NED), including 3 cohorts:
A. Initial treatment (primary lesion + retroperitoneal LN oligometastasis); B. Postoperative retroperitoneal/paravascular LN oligometastase; C. Postoperative retroperitoneal/paravascular LN metastasis with other organ metastases (up to NED)
ECOG PS 0-2
Ability to follow the program during the study period
Signing written informed consent
Exclusion Criteria:
Retroperitoneal LN metastasis is above the level of the renal vein.
Unable to reach NED.
Previous pelvic radiotherapy, the field of irradiation overlaps with this time.
Pregnancy or breastfeeding women.
Those with other history of malignant disease in the last 5 years, except for cured skin cancer and cervical carcinoma in situ.
If there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance.
Clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring medication intervention, Or a history of myocardial infarction in the last 12 months
Organ transplantation requires immunosuppressive therapy
Severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases
Subjects Blood routine and biochemical indicators do not meet the following criteria: hemoglobin ≥ 90g / L; absolute neutrophil count (ANC) ≥ 1.5 × 109 / L; platelets ≥ 100 × 109 / L; ALT, AST≤2.5 times normal upper limit; ALP≤2.5 times normal upper limit; serum total bilirubin <1.5 times normal upper limit; serum creatinine <1 times normal upper limit; serum albumin ≥30g/L
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Zhu, MD
Phone
+86-2164175590
Ext
81607
Email
leo.zhu@126.com
Facility Information:
Facility Name
Cancer Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Zhu, MD
12. IPD Sharing Statement
Learn more about this trial
CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC
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