Rectal Cancer, MetastaticPhase 2NCT03022734
Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis
A Phase 2 study testing chemotherapy and radiotherapy in people with Rectal Cancer, Metastatic, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rectal Cancer, Metastatic
- What is being tested?
- chemotherapy and radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Jun 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
- over 19 years
- Eastern Cooperative Oncology Group 0-1
- Proper organ function
- more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
- Who should sign on the Informed consent form before participate the trial.
Who cannot join
- Metastasis in other organ except liver
- Chronic active hepatitis or cirrhosis
- History of treatment for metastatic colorectal cancer
- Subject pregnant or breast feeding
- Uncontrolled disease
- Have had adjuvant therapy
Show all 10Show fewer
- Uncontrolled peripheral nerve infection
- Alcoholic or drug addict
- Subject currently is enrolled in or ≤30 days from ending other clinical trial.
- History of other type of cancer except resolved from skin cancer and cervical cancer.
Trial locations and contacts
1 site in 1 country.
Sang Joon Shin contact
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
Sang Joon Shin, 82-2-2228-8130
About this study
Official title: A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.
- Conditions
- Rectal Cancer, Metastatic
- Being tested
- chemotherapy, radiotherapy
- Medical subject headings
- Rectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemotherapyDrug
cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)
radiotherapyRadiation
After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy with radiotherapy | Experimental | Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy Receives: Drug: chemotherapy; Radiation: radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection (R0) rate for rectal and liver lesions
Measured: after surgical resection, an average of 24 weeks
Secondary outcomes (1)
Response rate (RECIST V1.1)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startSep 2016
- Primary completionJan 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer, MetastaticStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Joon Shin, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03022734
- Sponsor's protocol ID
- 4-2016-0410
- Status last verified
- Jan 2020
- First submitted
- 10 Jan 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
- ClinicalTrials.gov ID
- NCT03022734
- Acronym / sponsor ID
- 4-2016-0410
- Conditions
- Rectal Cancer, Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 16 Jan 2017 (estimated)
- 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.
The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy with radiotherapy | Experimental | Drug: chemotherapy, Radiation: radiotherapyCetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis
- over 19 years
- Eastern Cooperative Oncology Group 0-1
- Proper organ function
- more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1)
Key exclusion criteria (10 listed)
- Metastasis in other organ except liver
- Chronic active hepatitis or cirrhosis
- History of treatment for metastatic colorectal cancer
- Subject pregnant or breast feeding
- Uncontrolled disease
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 |
|---|---|---|
| chemotherapycetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) | Drug | chemotherapy with radiotherapy |
| radiotherapyAfter FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days. | Radiation | chemotherapy with radiotherapy |
Primary outcome
complete resection (R0) rate for rectal and liver lesions
Time frame: after surgical resection, an average of 24 weeks
1 secondary outcome
Response rate (RECIST V1.1)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Sang Joon Shin contact
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 chemotherapy and radiotherapy in people with Rectal Cancer, Metastatic, run by Yonsei University at 1 site in South Korea.
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 6 inclusion and 10 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 13 Jan 2020. 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 South Korea. 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 Sang Joon Shin (82-2-2228-8130), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete resection (R0) rate for rectal and liver lesions (time frame: after surgical resection, an average of 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2020.