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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Retroperitoneal Lymph Node Metastasis; Para-aortic Lymph Node Metastasis
• Intervention / Treatment: Procedure: lymphadenectomy; Radiation: chemoradiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Cancer Hospital, FuDan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization until the date of disease progressed for any reason, assessed up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From date of randomization until the date of death from any cause, assessed up to 5 years
local control rate	no recurrence of the retroperitoneal or paraaortic lymph node region.	From date of randomization until the date of disease recurrece, assessed up to 5 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 20, 2018
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 27, 2018
• First Posted (ACTUAL): October 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 19, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: IMRT; SBRT; Chemoradiotherapy; retroperitoneal lymphadenectomy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease Attributes; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Recurrence; Lymphatic Metastasis
• Other Study ID Numbers: FDRT-008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No