Colorectal CancerNCT01978249
A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
A study testing Systemic chemotherapy and primary tumor resection (PTR) in people with Colorectal Cancer, run by Yonsei University at 12 sites in South Korea.
Trial summary
Short description for lay public, include brief statement of the study hypothesis Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Systemic chemotherapy and primary tumor resection (PTR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Sep 2013to Nov 2015
- Phase
- Interventional
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age : between 20 and 90 years old
- Histologically confirmed adenocarcinoma of the colon or the upper rectum
- Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions.
- Patients with no primary cancer related symptoms.
- ECOG performance status of 0 - 2
- Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
- ASA score of < 3
- An informed consent form has been signed by the patient.
Who cannot join
- The patient received adjuvant chemotherapy within the past 6 months.
- The patient received chemotherapy for metastatic colon cancer.
- The patient was planning to have curative surgery for the metastatic lesions.
- The primary cancer is unresectable.
- Patients with peritoneal carcinomatosis.
- Patients with mid and low rectal cancer (< 10cm)
Show all 13Show fewer
- Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
- ASA score of > 4
- The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
- Patients with an active infection, which need antibiotic therapy, during the randomization period.
- Pregnant or breastfeeding women
- Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period).
- Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
Yeongnam University Hospital
Daegu, Gyeongsang-do
Kyungpook National University Hospital
Daegu
Chonnam National University Hospital
Gwangju, Jeonlla Nam-do
Wonkwang University Hospital
Iksan, Jeollabukdo
National Cancer Center
Ilsan, Gyeonggi-do
Gachon University, Gil Hospital
Incheon, Gyeonggi-do
Seoul National University, Bundang Hospital
Seongnam-si, Gyeonggi-do
Department of Surgery, Yonsei University College of Medicine
Seoul, 120-752
Asan Medical Center
Seoul
Seoul National University Hospital
Seoul
Yonsei University, Gangnam Severance Hospital
Seoul
About this study
Short description for lay public, include brief statement of the study hypothesis
- Conditions
- Colorectal Cancer
- Being tested
- Systemic chemotherapy, primary tumor resection (PTR)
- Keywords
- Colorectal cancer, Primary tumor resection, Chemotherapy, Overall survival, Quality of life
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic chemotherapyProcedure or surgery
primary tumor resection (PTR)Procedure or surgery
primary tumor resection (PTR) using open or laparoscopy or robotic surgery
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy first without primary tumor resection | Experimental | Patients will receive chemotherapy first without primary tumor resection. Receives: Procedure: Systemic chemotherapy |
| Primary tumor resection followed by chemotherapy | Active comparator | Patients will receive primary tumor resection followed by chemotherapy. Receives: Procedure: primary tumor resection (PTR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
Comparison of the overall survival between patients who underwent primary tumor resection followed by chemotherapy and patients who received chemotherapy without primary tumor resection in stage IV colorectal cancer patients with unresectable metastasis.
Measured: 2 years after allocation
Secondary outcomes (1)
Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group.
Measured: 2 years after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Because of the difficulties of participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978249
- Sponsor's protocol ID
- 4-2013-0277
- Status last verified
- Aug 2018
- First submitted
- 31 Oct 2013
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim CW, Baek JH, Choi GS, Yu CS, Kang SB, Park WC, Lee BH, Kim HR, Oh JH, Kim JH, Jeong SY, Ahn JB, Baik SH. The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial. Trials. 2016 Jan 19;17:34. doi: 10.1186/s13063-016-1164-0.
PubMed 26782254
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
- ClinicalTrials.gov ID
- NCT01978249
- Acronym / sponsor ID
- 4-2013-0277
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, Primary tumor resection, Chemotherapy, Overall survival, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of the difficulties of participant enrollment.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 7 Nov 2013 (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.
Short description for lay public, include brief statement of the study hypothesis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy first without primary tumor resection | Experimental | Procedure: Systemic chemotherapyPatients will receive chemotherapy first without primary tumor resection. |
| Primary tumor resection followed by chemotherapy | Active comparator | Procedure: primary tumor resection (PTR)Patients will receive primary tumor resection followed by chemotherapy. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age : between 20 and 90 years old
- Histologically confirmed adenocarcinoma of the colon or the upper rectum
- Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions.
- Patients with no primary cancer related symptoms.
- ECOG performance status of 0 - 2
Key exclusion criteria (13 listed)
- The patient received adjuvant chemotherapy within the past 6 months.
- The patient received chemotherapy for metastatic colon cancer.
- The patient was planning to have curative surgery for the metastatic lesions.
- The primary cancer is unresectable.
- Patients with peritoneal carcinomatosis.
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 |
|---|---|---|
| Systemic chemotherapy | Procedure or surgery | Chemotherapy first without primary tumor resection |
| primary tumor resection (PTR)primary tumor resection (PTR) using open or laparoscopy or robotic surgery | Procedure or surgery | Primary tumor resection followed by chemotherapy |
Primary outcome
Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
Time frame: 2 years after allocation
Comparison of the overall survival between patients who underwent primary tumor resection followed by chemotherapy and patients who received chemotherapy without primary tumor resection in stage IV colorectal cancer patients with unresectable metastasis.
1 secondary outcome
Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group.
Time frame: 2 years after allocation
Results and safety
The study was stopped early (reason given: Because of the difficulties of participant enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
- Derived from this study: PubMed 26782254Kim CW, Baek JH, Choi GS, Yu CS, Kang SB, Park WC, Lee BH, Kim HR, Oh JH, Kim JH, Jeong SY, Ahn JB, Baik SH. The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial. Trials. 2016 Jan 19;17:34. doi: 10.1186/s13063-016-1164-0.
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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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic chemotherapy and primary tumor resection (PTR) in people with Colorectal Cancer, run by Yonsei University at 12 sites 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
Are results available for this study?
The study was stopped early (reason given: Because of the difficulties of participant enrollment.). Results are not available in the source record.
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?
Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection (time frame: 2 years after allocation). 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 NCT01978249, which also lists 1 linked publication.
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 14 Aug 2018.