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

Phase 2

Recruiting

• Conditions: Colorectal Cancer; Retroperitoneal Lymph Node Metastasis; Para-aortic Lymph Node Metastasis
• Interventions: Radiation: chemoradiotherapy; Procedure: lymphadenectomy

• Registration Number: NCT03725254
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-10
• Study Start: 2018-10-20
• Study First Submitted QC: 2018-10-27
• Study First Posted: 2018-10-31
• Last Update Submitted: 2019-01-19
• Last Update Posted: 2019-01-23
• Primary Completion: 2021-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
radical chemoradiotherapy	chemoradiotherapy	In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
radical surgery	lymphadenectomy	In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Cancer Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China