RadiotherapyPhase 2NCT03135652
Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation
A Phase 2 study testing adjuvant SBRT and Chemotherapy in people with Radiotherapy and Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Radiotherapy, Colorectal Cancer, Liver Metastases
- What is being tested?
- adjuvant SBRT and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 1 Jun 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
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.
Read the 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
- Being tested
- adjuvant SBRT, Chemotherapy
- Keywords
- Radiotherapy, Colorectal Cancer, Liver Metastases
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adjuvant SBRTRadiation
Also called radiotherapy
adjuvant SBRT of liver lesions
ChemotherapyDrug
Also called neoadjuvant chemotherapy and adjuvant chemotherapy
mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
| Study group | Role | What they receive |
|---|---|---|
| chemoradiotherapy | Experimental | radiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment Receives: Radiation: adjuvant SBRT; Drug: Chemotherapy |
| chemotherapy | Active comparator | chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival
Measured: 2 years
Secondary outcomes (3)
Overall survival
To evaluate overall survival after consolidative SBRT in comparison to observation alone
Measured: 5 years
Intrahepatic disease free survival
To evaluate Intrahepatic disease free survival after consolidative SBRT in comparison to observation alone
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Aug 2017
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2023 (estimated)
Why it stopped: Inadequate patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RadiotherapyStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- adjuvant radiotherapy:SBRT chemotherapy:mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao Zhang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135652
- Sponsor's protocol ID
- CRLM-AR1
- Status last verified
- Dec 2023
- First submitted
- 26 Apr 2017
- Last updated
- 3 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8608500Gomez 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.
PubMed 27789196
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consolidative Radiotherapy for Colorectal Cancer Liver Metastases Receiving Surgery or Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT03135652
- Acronym / sponsor ID
- CRLM-AR1
- Conditions
- Radiotherapy, Colorectal Cancer, Liver Metastases
- Keywords
- Radiotherapy, Colorectal Cancer, Liver Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Inadequate patient enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- adjuvant radiotherapy:SBRT chemotherapy:mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab
| Arm | Type | Receives |
|---|---|---|
| chemoradiotherapy | Experimental | Radiation: adjuvant SBRT, Drug: Chemotherapyradiotherapy: adjuvant SBRT of liver lesions; chemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment |
| chemotherapy | Active comparator | Drug: Chemotherapychemotherapy: mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adjuvant SBRTAlso: radiotherapyadjuvant SBRT of liver lesions | Radiation | chemoradiotherapy |
| ChemotherapyAlso: neoadjuvant chemotherapy and adjuvant chemotherapymFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment | Drug | chemoradiotherapy, chemotherapy |
Primary outcome
Disease free survival
Time frame: 2 years
Evaluate the effect of consolidative SBRT of liver lesions versus observation on disease free survival
3 secondary outcomes
Overall survival
Time frame: 5 years
Intrahepatic disease free survival
Time frame: 2 years
Toxicities
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Results publication: PubMed 8608500Nordlinger 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 publication: PubMed 27789196Gomez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing adjuvant SBRT and Chemotherapy in people with Radiotherapy and Colorectal Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03135652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.