CRT Versus Surgery for Retroperitoneal or Paraaortic Lymp... | NCT03725254

NCT03725254

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lymphadenectomy	Procedure	The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.	radical surgery

Outcomes Module

Primary Outcomes

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 Outcomes

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

Eligibility Module

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

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D008197	Lymph Node Excision
D059248	Chemoradiotherapy

ID	Term
D013514	Surgical Procedures, Operative
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy