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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03135652
Other study ID # CRLM-AR1
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date August 1, 2017
Est. completion date June 1, 2023

Study information

Verified date December 2023
Source Wuhan Union Hospital, China
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized phase II trial to evaluate the efficacy of adjuvant consolidative radiotherapy in colorectal cancer liver metastasis (CRLM) patients after chemotherapy combined with surgical resection or radiofrequency ablation of liver lesions.


Description:

Liver metastases are detected in 40-50% of patients diagnosed with colorectal cancer. Local treatments like surgical resection or radiofrequency ablation result in 5-year survival of 35%. However, relapse still occurs in 70% of patients. Stereotactic body radiotherapy (SBRT) has emerged as a valid treatment not only to provide excellent symptom palliation, but also is effective in local control of metastatic lesions and improves survival. The potential efficacy of SBRT as adjuvant radiotherapy in CRLM patients after surgical resection or radiofrequency ablation is still unknown.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 1, 2023
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Biopsy proven unresectable metastatic colorectal cancer (CRC) 2. Primary resection of colorectal cancer (CRC) 3. Age=18 years 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 5. Absence of evidence of extra-hepatic diseases 6. 1 to 3 liver metastases with an individual maximum diameter of up to 5 cm 7. Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed 8. Aspartate aminotransferase, alanine aminotransferase & alkaline phosphates must be = 2.5 times of the upper limit of normal. Total bilirubin must be within the limit of normal. 9. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of =1500/mm3. 10. Patients must provide verbal and written informed consent to participate in the study. 11. Absence of any severe pulmonary or cardiac diseases Exclusion Criteria: 1. Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible 2. Patients who are pregnant 3. Patients with severe organ dysfunction 4. History of liver radiotherapy 5. Unwillingness to participate or inability to comply with the protocol for the duration of the study 6. Participation in any investigational drug study within 3 months preceding the start of study treatment 7. Patients not suitable to take part in clinical trials judged by researches

Study Design


Intervention

Radiation:
adjuvant SBRT
adjuvant SBRT of liver lesions
Drug:
Chemotherapy
mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Locations

Country Name City State
China Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (2)

Gomez DR, Blumenschein GR Jr, Lee JJ, Hernandez M, Ye R, Camidge DR, Doebele RC, Skoulidis F, Gaspar LE, Gibbons DL, Karam JA, Kavanagh BD, Tang C, Komaki R, Louie AV, Palma DA, Tsao AS, Sepesi B, William WN, Zhang J, Shi Q, Wang XS, Swisher SG, Heymach J — View Citation

Nordlinger B, Guiguet M, Vaillant JC, Balladur P, Boudjema K, Bachellier P, Jaeck D. Surgical resection of colorectal carcinoma metastases to the liver. A prognostic scoring system to improve case selection, based on 1568 patients. Association Francaise d — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Disease free survival Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival 2 years
Secondary Overall survival To evaluate overall survival after consolidative SBRT in comparison to observation alone 5 years
Secondary Intrahepatic disease free survival To evaluate Intrahepatic disease free survival after consolidative SBRT in comparison to observation alone 2 years
Secondary Toxicities Acute toxicity was scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v3.0 criteria during and up to 3 months after radiotherapy. Late toxicity was graded using the Radiation Therapy Oncology Group (RTOG)/European Organisation for the Research and Treatment of Cancer (EORTC) criteria. 2 years
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