CRT Versus Surgery for Retroperitoneal or Paraaortic Lymph Node Recurrence of CRC
NCT ID: NCT03725254
Last Updated: 2019-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
180 participants
INTERVENTIONAL
2018-10-20
2024-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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radical surgery
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical surgery.
lymphadenectomy
The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.
radical chemoradiotherapy
In this arm, patients with retroperitoneal or paraaortic lymph node recurrence will receive radical chemoradiotherapy.
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).
Interventions
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lymphadenectomy
The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhu Ji
professor
Locations
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Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Ji Zhu, MD
Role: primary
Other Identifiers
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FDRT-008
Identifier Type: -
Identifier Source: org_study_id
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