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

NCT ID: NCT03135652

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2023-06-01

Brief 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.

Detailed 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.

Conditions

Radiotherapy; Colorectal Cancer; Liver Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemoradiotherapy

radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Group Type: EXPERIMENTAL

adjuvant SBRT

Intervention Type: RADIATION

adjuvant SBRT of liver lesions

Chemotherapy

Intervention Type: DRUG

mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

chemotherapy

chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Interventions

adjuvant SBRT

adjuvant SBRT of liver lesions

Intervention Type: RADIATION

Chemotherapy

mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment

Intervention Type: DRUG

Other Intervention Names

radiotherapy; neoadjuvant chemotherapy and adjuvant chemotherapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Tao Zhang

Chief of Gastrointestinal Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

References

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 de Chirurgie. Cancer. 1996 Apr 1;77(7):1254-62.

Reference Type: RESULT

PMID: 8608500 (View on PubMed)

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 JV. Local consolidative therapy versus maintenance therapy or observation for patients with oligometastatic non-small-cell lung cancer without progression after first-line systemic therapy: a multicentre, randomised, controlled, phase 2 study. Lancet Oncol. 2016 Dec;17(12):1672-1682. doi: 10.1016/S1470-2045(16)30532-0. Epub 2016 Oct 24.

Reference Type: RESULT

PMID: 27789196 (View on PubMed)

Other Identifiers

CRLM-AR1

Identifier Type: -

Identifier Source: org_study_id