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

NCT03725254 | Unknown Phase 2

• 1 other identifier: FDRT-008
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Chemoradiotherapy; retroperitoneal lymphadenectomy; IMRT; SBRT

Outcome Measures

Primary Outcomes (1)

• 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 (2)

• overall survival

  From date of randomization until the date of death from any cause, assessed up to 5 years

• local control rate

  From date of randomization until the date of disease recurrece, assessed up to 5 years

Study Arms (2)

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

lymphadenectomy PROCEDURE

The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.

radical surgery

chemoradiotherapy RADIATION

Radiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT).

radical chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lymph Node Excision; Chemoradiotherapy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Ji Zhu, MD

CONTACT

+86-2164175590; leo.zhu@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: October 31, 2018
• Study Start: October 20, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2024
• Last Updated: January 23, 2019

Record last verified: 2018-10

Locations

CN (1)