CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03725254

Collaborator

(none)

180

Enrollment

Location

Arms

71.4

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Retroperitoneal Lymph Node Metastasis Para-aortic Lymph Node Metastasis	Procedure: lymphadenectomy Radiation: chemoradiotherapy	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Curative Chemoradiotherapy Versus Radical Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of Colorectal Cancer

Actual Study Start Date :

Oct 20, 2018

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: radical surgery In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.	Procedure: lymphadenectomy The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.
Experimental: radical chemoradiotherapy In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.	Radiation: chemoradiotherapy Radiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT).

Arm

Intervention/Treatment

Active Comparator: radical surgery

In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.

Procedure: lymphadenectomy

The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.

Experimental: radical chemoradiotherapy

In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.

Radiation: chemoradiotherapy

Radiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT).

Outcome Measures

Primary Outcome Measures

Progression-free survival [From date of randomization until the date of disease progressed for any reason, assessed up to 5 years]
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 [From date of randomization until the date of death from any cause, assessed up to 5 years]
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 [From date of randomization until the date of disease recurrece, assessed up to 5 years]
no recurrence of the retroperitoneal or paraaortic lymph node region.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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