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

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Fudan University

Status and phase

Enrolling
Phase 2

Conditions

Para-aortic Lymph Node Metastasis
Retroperitoneal Lymph Node Metastasis
Colorectal Cancer

Treatments

Radiation: chemoradiotherapy
Procedure: lymphadenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT03725254
FDRT-008

Details and patient eligibility

About

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.

Enrollment

180 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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:

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

180 participants in 2 patient groups

radical surgery
Active Comparator group
Description:
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.
Treatment:
Procedure: lymphadenectomy
radical chemoradiotherapy
Experimental group
Description:
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
Treatment:
Radiation: chemoradiotherapy

Trial contacts and locations

0

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Central trial contact

Ji Zhu, MD

Data sourced from clinicaltrials.gov

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