Metastatic Colorectal CancerPhase 2MCRC-LC1NCT03142282
Consolidative Radiotherapy Plus Maintenance Chemotherapy for Metastatic Colorectal Cancer
A Phase 2 study testing maintenance chemotherapy and Consolidative Radiotherapy in people with Metastatic Colorectal Cancer and Radiotherapy, 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 of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastatic Colorectal Cancer, Radiotherapy
- What is being tested?
- maintenance chemotherapy and Consolidative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Aug 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have biopsy proven unresectable MCRC.
- Patients must have received induction chemotherapy for 3-6 months, and achieved stable disease or a partial response.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
- Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
- Patients who previously received radiotherapy to the primary site will be ineligible if there is CT evidence of disease progression within the past 3 months.
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- Patients must have a Karnofsky Performance Scores (KPS) >60
- Aspartate aminotransferase, alanine aminotransferase \& Alkaline phosphates must be ≤ 2.5 times the upper limit of normal (ULN). 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 should have adequate renal function (serum creatinine ≤1.5 times the ULN).
- Females of childbearing potential should have a negative pregnancy test.
- Patients who would be receiving radiation for lung lesions who are known or suspected by the treating radiation oncologist to have compromised lung function must have a documented forced expiratory volume in 1 second (FEV1) ≥ 1 litre.
- Patients must provide verbal and written informed consent to participate in the study.
- Total bilirubin: within normal institutional limits
Who cannot join
- Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- Patients with serious, uncontrolled, concurrent infection(s).
- Significant weight loss (>10%) in the prior 3 months.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
- Patients with more than 5 discrete metastatic lesions.
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
- Patients who are pregnant. Patients with reproductive capability will need to use adequate contraception during the time of participation in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Tao Zhang, MD, PHD, 862785871982, 1277577866@qq.com
Zhenyu Lin, MD, 15827130393, tojilin@gmail.com
About this study
Official title: Maintenance Chemotherapy Versus Consolidative Radiotherapy Plus Maintenance Chemotherapy for Unresectable Metastatic Colorectal Cancer: A Randomized Phase II Trial
This study is a randomized phase II trial of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC).
Read the detailed description
Prior to accrual on the trial, patients with unresectable metastatic colorectal cancer will be treated with palliative chemotherapy. And patients who achieve a partial response or stable disease by imaging criteria will receive maintenance chemotherapy. In our study, these group patients will be randomized to maintenance chemotherapy or consolidative radiotherapy to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of palliative and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.
- Conditions
- Metastatic Colorectal Cancer, Radiotherapy
- Being tested
- maintenance chemotherapy, Consolidative Radiotherapy
- Keywords
- maintenance treatment
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance chemotherapyDrug
National Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) suggested maintenance chemotherapy regimens: xeloda, bevacizumab
Consolidative RadiotherapyRadiation
Stereotacticbodyradiationtherapy (SBRT) or intensity modulated radiation therapy (IMRT) for metastatic sites (less than 5)
| Study group | Role | What they receive |
|---|---|---|
| Maintenance chemotherapy | Active comparator | FDA approved drugs for the study population: Bevacizumab, Xeloda Receives: Drug: maintenance chemotherapy |
| Radiotherapy | Experimental | consolidative radiotherapy plus maintenance chemotherapy Receives: Radiation: Consolidative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Evaluate the effect of consolidative radiotherapy with or without maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival
Measured: 2 years
Secondary outcomes (3)
Actuarial rate in-field local control
To describe the actuarial rate in-field local control and rate of out-of-field disease progression
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
Overall survival
To evaluate overall survival after consolidative radiotherapy followed by maintenance chemotherapy in comparison to maintenance chemotherapy alone.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start1 Jan 2019 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2024 (estimated)
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 Metastatic Colorectal CancerStudies 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
- Radiation: SBRT or IMRT Drug: Maintenance chemotherapy
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
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
- Investigators
- Tao Zhang, MD,PHD, Study chair, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan 430022, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142282
- Sponsor's protocol ID
- MCRC-LC1
- Acronym
- MCRC-LC1
- Status last verified
- Sep 2018
- First submitted
- 26 Apr 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Kohne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Osterlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taieb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.
PubMed 27380959Gomez 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 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintenance Chemotherapy Versus Consolidative Radiotherapy Plus Maintenance Chemotherapy for Unresectable Metastatic Colorectal Cancer: A Randomized Phase II Trial
- ClinicalTrials.gov ID
- NCT03142282
- Acronym / sponsor ID
- MCRC-LC1 / MCRC-LC1
- Conditions
- Metastatic Colorectal Cancer, Radiotherapy
- Keywords
- maintenance treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 5 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 of maintenance chemotherapy versus consolidative radiotherapy plus maintenance chemotherapy for patients with unresectable metastatic colorectal cancer (MCRC).
Detailed description
Prior to accrual on the trial, patients with unresectable metastatic colorectal cancer will be treated with palliative chemotherapy. And patients who achieve a partial response or stable disease by imaging criteria will receive maintenance chemotherapy. In our study, these group patients will be randomized to maintenance chemotherapy or consolidative radiotherapy to all sites of disease (followed by maintenance chemotherapy at the medical oncologist's discretion). Choices of palliative and maintenance chemotherapy will be determined by the medical oncologist based on clinical appropriateness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Radiation: SBRT or IMRT Drug: Maintenance chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Maintenance chemotherapy | Active comparator | Drug: maintenance chemotherapyFDA approved drugs for the study population: Bevacizumab, Xeloda |
| Radiotherapy | Experimental | Radiation: Consolidative Radiotherapyconsolidative radiotherapy plus maintenance chemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients must have biopsy proven unresectable MCRC.
- Patients must have received induction chemotherapy for 3-6 months, and achieved stable disease or a partial response.
- Age ≥ 18 years
- Patients must have measurable disease at baseline.
- Patients can have up to only 5 discrete active extracranial lesions (≤3 in the liver and ≤3 in the lung) identified by position-emission tomography (PET) scan and also seen on correlative plain film, CT scan, or MRI within 8 weeks prior to the initiation of radiotherapy.
Key exclusion criteria (8 listed)
- Patients with either untreated brain metastases or brain metastases treated within the past three months are ineligible
- Patients with serious, uncontrolled, concurrent infection(s).
- Significant weight loss (>10%) in the prior 3 months.
- Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cancers.
- Patients with more than 5 discrete metastatic lesions.
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 |
|---|---|---|
| maintenance chemotherapyNational Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) suggested maintenance chemotherapy regimens: xeloda, bevacizumab | Drug | Maintenance chemotherapy |
| Consolidative RadiotherapyStereotacticbodyradiationtherapy (SBRT) or intensity modulated radiation therapy (IMRT) for metastatic sites (less than 5) | Radiation | Radiotherapy |
Primary outcome
Progression free survival
Time frame: 2 years
Evaluate the effect of consolidative radiotherapy with or without maintenance chemotherapy versus maintenance chemotherapy alone on progression free survival
3 secondary outcomes
Actuarial rate in-field local control
Time frame: 2 years
Toxicities
Time frame: 2 years
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Results publication: PubMed 27380959Van Cutsem E, Cervantes A, Adam R, Sobrero A, Van Krieken JH, Aderka D, Aranda Aguilar E, Bardelli A, Benson A, Bodoky G, Ciardiello F, D'Hoore A, Diaz-Rubio E, Douillard JY, Ducreux M, Falcone A, Grothey A, Gruenberger T, Haustermans K, Heinemann V, Hoff P, Kohne CH, Labianca R, Laurent-Puig P, Ma B, Maughan T, Muro K, Normanno N, Osterlund P, Oyen WJ, Papamichael D, Pentheroudakis G, Pfeiffer P, Price TJ, Punt C, Ricke J, Roth A, Salazar R, Scheithauer W, Schmoll HJ, Tabernero J, Taieb J, Tejpar S, Wasan H, Yoshino T, Zaanan A, Arnold D. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer. Ann Oncol. 2016 Aug;27(8):1386-422. doi: 10.1093/annonc/mdw235. Epub 2016 Jul 5.
- 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.
- Individual participant dataSharing planned: No
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CRC
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.
Tao Zhang, MD,PHD study chair
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology , Wuhan 430022, China.
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 maintenance chemotherapy and Consolidative Radiotherapy in people with Metastatic Colorectal Cancer and Radiotherapy, 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 14 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Sep 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Zhang, MD,PHD (862785871982, 1277577866@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression 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 NCT03142282, 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 7 Sep 2018.