Clinical trial NCT03725254: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Retroperitoneal Lymph Node Metastasis
Para-aortic Lymph Node Metastasis
Keywords: Chemoradiotherapy
retroperitoneal lymphadenectomy
IMRT
SBRT
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Progression-free survival
timeFrame: From date of randomization until the date of disease progressed for any reason, assessed up to 5 years
Secondary outcomes:
measure: overall survival
timeFrame: From date of randomization until the date of death from any cause, assessed up to 5 years
measure: local control rate
timeFrame: From date of randomization until the date of disease recurrece, assessed up to 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital, Fudan University
state: Shanghai
Study officials:
References: