Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation

Colorectal Cancer Clinical Trial

Official title:

Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03135652
• Other study ID #: CRLM-AR1
• Status: Withdrawn
• Phase: Phase 2
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Radiotherapy

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