Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

NCT03127072 | Unknown Phase 4 DMC

• 1 other identifier: RFACRLM
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.

Conditions

Colorectal Cancer Liver Metastasis

Keywords

colorectal cancer; liver metastasis; Radiofrequency Ablation; chemotherapy; target therapy

Outcome Measures

Primary Outcomes (1)

• Overall survival in subjects receiving RFA plus chemotherapy ± target therapy compared to chemotherapy ± target therapy alone was assessed from the date of study entry until death from the disease.

  3 years

Secondary Outcomes (1)

• The differences in the incidence or severity of adverse events in the RFA plus chemotherapy ± target therapy arm compared to the chemotherapy ± target therapy only arm were was assessed by of complications after therapy.

  30 days post therapy

Study Arms (2)

Arm A

EXPERIMENTAL

RFA plus chemotherapy ± target therapy

Device: Radiofrequency Ablation (RFA); Drug: chemotherapy ± target therapy

Arm B

ACTIVE COMPARATOR

chemotherapy ± target therapy

Drug: chemotherapy ± target therapy

Interventions

Radiofrequency Ablation (RFA) DEVICE

The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue

Arm A

chemotherapy ± target therapy DRUG

chemotherapy ± target therapy

Arm A; Arm B

Eligibility Criteria

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

You may qualify if:

• All patients must meet the following criteria:
• Patients must have incurable CRLM
• Patients must have no more than 10 liver metastases (LMs) remaining after surgical resection, with diameter less than 5cm
• Patients is medically eligible to receive RFA, as determined by the MDT (multidisciplinary team)
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
• Age \> 18 years
• Subject life expectancy \> 3 months
• Platelets \> 100×103/mm3
• Total bilirubin \<1.5mg/dl
• Creatinine level \< 2.0 mg/dl
• All patients must sign an informed consent form

You may not qualify if:

• The CRLM is amenable to curative surgical therapy
• Uncorrectable coagulopathy
• Subject is pregnant, nursing, or wishes to become pregnant during the study
• Other serious medical condition (uncontrolled infection, uncontrolled cardiac disease) would preclude study treatment or impact survival
• Current or planned treatment with any experimental chemotherapy or target drugs

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan hosptial, Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Radiofrequency Ablation

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)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Jianmin Xu, PhD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Jianmin Xu, PhD

CONTACT

+86-13501984869; xujmin@aiiyun.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 19, 2017
• First Posted: April 25, 2017
• Study Start: April 30, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2021
• Last Updated: April 25, 2017

Record last verified: 2017-04

Locations

CN (1)