Back to results

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

Primary Purpose

Radiotherapy, Colorectal Cancer, Liver Metastases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

adjuvant SBRT

Chemotherapy

About this trial

This is an interventional treatment trial for Radiotherapy focused on measuring Radiotherapy, Colorectal Cancer, Liver Metastases

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Biopsy proven unresectable metastatic colorectal cancer (CRC)
Primary resection of colorectal cancer (CRC)
Age≥18 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Absence of evidence of extra-hepatic diseases
1 to 3 liver metastases with an individual maximum diameter of up to 5 cm
Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed
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.
Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3.
Patients must provide verbal and written informed consent to participate in the study.
Absence of any severe pulmonary or cardiac diseases

Exclusion Criteria:

Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
Patients who are pregnant
Patients with severe organ dysfunction
History of liver radiotherapy
Unwillingness to participate or inability to comply with the protocol for the duration of the study
Participation in any investigational drug study within 3 months preceding the start of study treatment
Patients not suitable to take part in clinical trials judged by researches

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chemoradiotherapy

chemotherapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Disease free survival

Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival

Secondary Outcome Measures

Overall survival

To evaluate overall survival after consolidative SBRT in comparison to observation alone

Intrahepatic disease free survival

To evaluate Intrahepatic disease free survival after consolidative SBRT in comparison to observation alone

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.

Full Information

NCT ID

NCT03135652

First Posted

April 26, 2017

Last Updated

November 16, 2019

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT03135652

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2017 (Actual)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Radiotherapy, Colorectal Cancer, Liver Metastases

Keywords

Radiotherapy, Colorectal Cancer, Liver Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

adjuvant radiotherapy:SBRT chemotherapy:mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

chemoradiotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

chemotherapy

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

adjuvant SBRT

Other Intervention Name(s)

radiotherapy

Intervention Description

adjuvant SBRT of liver lesions

Intervention Type

Drug

Intervention Name(s)

Chemotherapy

Other Intervention Name(s)

neoadjuvant chemotherapy and adjuvant chemotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Disease free survival

Description

Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival

Description

To evaluate overall survival after consolidative SBRT in comparison to observation alone

Time Frame

5 years

Title

Intrahepatic disease free survival

Description

To evaluate Intrahepatic disease free survival after consolidative SBRT in comparison to observation alone

Time Frame

2 years

Title

Toxicities

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Biopsy proven unresectable metastatic colorectal cancer (CRC) Primary resection of colorectal cancer (CRC) Age≥18 years Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Absence of evidence of extra-hepatic diseases 1 to 3 liver metastases with an individual maximum diameter of up to 5 cm Metastatic liver lesions receiving R0 or R1 resection or radiofrequency ablation with visible tumor bed 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. Patients should have adequate bone marrow function as defined by peripheral granulocyte count of ≥1500/mm3. Patients must provide verbal and written informed consent to participate in the study. Absence of any severe pulmonary or cardiac diseases Exclusion Criteria: Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible Patients who are pregnant Patients with severe organ dysfunction History of liver radiotherapy Unwillingness to participate or inability to comply with the protocol for the duration of the study Participation in any investigational drug study within 3 months preceding the start of study treatment Patients not suitable to take part in clinical trials judged by researches

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tao Zhang, MD

Phone

862785871982

1277577866@qq.com

Facility Information:

Facility Name

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

City

Wuhan

State/Province

Hubei

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tao Zhang, MD, PHD

Phone

862785871982

1277577866@qq.com

First Name & Middle Initial & Last Name & Degree

Zhenyu Lin, MD

Phone

15827130393

tojilin@gmail.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

8608500

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

Results Reference

result

PubMed Identifier

27789196

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs