Colorectal CancerPhase 3IOCCRCNCT01465451
Intra-operative Chemotherapy With 5-FU for Colorectal Cancer Patients Receiving Curative Resection: Efficacy and Safety
A Phase 3 study testing curative resection for colorectal cancer and intra-operative 5-FU chemotherapy in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- curative resection for colorectal cancer and intra-operative 5-FU chemotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 695 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2019
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed as adenocarcinoma of colon and rectum
- age 18-75 years
- eligible for curative surgical resection
- performance score: ECOG 0-1
- normal blood cells counts: WBC ≥ 4.0×10*9/L，PLT ≥ 100×10*9/L
- normal blood chemistry test: ALT/AST ≤ 2.5 ULN, TBil ≤ 1.5 ULN, BUN ≤ 1.5 ULN,Cr ≤ 1.5 ULN
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- normal ECG
- no history of other malignant tumors
- no concomitant anti-cancer therapy
Who cannot join
- clinical bowel obstruction
- anticipated into another clinical trial within three months
- uncontrolled infection, serious internal medical diseases
- Pregnant or lactating women
- mentally abnormal patients
- patients known allergic to 5-FU
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery, 14Th Floor, Main Building, Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510060
About this study
Official title: A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer
The purpose of this study is to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.
- Conditions
- Colorectal Cancer
- Being tested
- curative resection for colorectal cancer, intra-operative 5-FU chemotherapy
- Keywords
- colorectal cancer, curative resection, intra-operative chemotherapy, 5-fluorouracil, chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curative resection for colorectal cancerProcedure or surgery
Also called curative resection for colorectal cancer.
right hemicolectomy for right colon cancer, transverse colectomy for transverse colon cancer, left hemicolectomy for left colon cancer, sigmoid colectomy for sigmoid colon cancer, and anterior resection or abdominal-perineal resection for rectal cancer.
intra-operative 5-FU chemotherapyDrug
Also called intra-operative 5-FU chemotherapy for colorectal cancer
5-FU, 1000 mg/m2, injection into bowel lumen at the beginning of resection 5-FU, 200 mg/m2, injection into portal vein via mesentery vein at the end of tumor removal and bowel reconstruction.
5-FU, 300 mg/m2, left in abdominal cavity before incision closure. surgical procedures will be the same as described in ARM A.
| Study group | Role | What they receive |
|---|---|---|
| ARM A- surgery alone | Active comparator | all cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy. Receives: Procedure: curative resection for colorectal cancer |
| ARM B surgery plus chemotherapy | Experimental | all cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation. Receives: Procedure: curative resection for colorectal cancer; Drug: intra-operative 5-FU chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
Measured: 3 years
Secondary outcomes (2)
disease-free survival
5 years survival of recurrence-free, metastasis-free, and death-free survival after randomization.
Measured: 5 years
safety profiles
complete blood cells counts, blood chemistry testing, all 28-day mortality after operation, all surgery-related complications
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
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 Sun Yat-sen 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 695 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHI-ZHONG PAN, Sun Yat-sen University
- Investigators
- zhizhong pan, MD, PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465451
- Sponsor's protocol ID
- SYSU 5010-2010016 IOCCRC
- Acronym
- IOCCRC
- Status last verified
- Aug 2016
- First submitted
- 1 Nov 2011
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang RX, Lin JZ, Lei J, Chen G, Li LR, Lu ZH, Ding PR, Huang JQ, Kong LH, Wang FL, Li C, Jiang W, Ke CF, Zhou WH, Fan WH, Liu Q, Wan DS, Wu XJ, Pan ZZ. Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC). J Cancer Res Clin Oncol. 2017 Dec;143(12):2581-2593. doi: 10.1007/s00432-017-2489-0. Epub 2017 Aug 28.
PubMed 28849265
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Single-center,Randomized,Controlled Phase III Clinical Study Comparing Efficacy and Safety of Intraoperative Chemotherapy With 5-Fluorouracil Plus Curative Resection Versus Surgery Alone for Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01465451
- Acronym / sponsor ID
- IOCCRC / SYSU 5010-2010016 IOCCRC
- Conditions
- Colorectal Cancer
- Keywords
- colorectal cancer, curative resection, intra-operative chemotherapy, 5-fluorouracil, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 695 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Nov 2011 (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 to investigate efficacy and safety of intra-operative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection. The hypothesis is intra-operative intervention might be the best timing for cancer cells killing by cytotoxic agents, when most of residual cancer cells may get a rapid growth after tumor debulking and may become more chemotherapy-sensitive. A three-step procedure is designed for intra-operative chemotherapy with 5-FU of 1500 mg/m2, including step 1 of intraluminal 5-FU injection with 1000 mg/m2 at beginning of resection, step 2 of 200mg/m2 5-FU injection into portal vein system via mesentery vein after tumor removal and finish of bowel reconstruction, and step 3 of 300mg/m2 5-FU left into the abdominal cavity before incision closure. The controlled arm receive curative resection only. All the other treatments will stick to the guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM A- surgery alone | Active comparator | Procedure: curative resection for colorectal cancerall cases will receive standard surgical procedures of curative resection for colorectal cancer, without intra-operative chemotherapy. |
| ARM B surgery plus chemotherapy | Experimental | Procedure: curative resection for colorectal cancer, Drug: intra-operative 5-FU chemotherapyall cases will receive standard surgical procedures described as arm A. In addition, all cases will receive 5-FU chemotherapy during operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- histologically confirmed as adenocarcinoma of colon and rectum
- age 18-75 years
- eligible for curative surgical resection
- performance score: ECOG 0-1
- normal blood cells counts: WBC ≥ 4.0×10*9/L，PLT ≥ 100×10*9/L
Key exclusion criteria (6 listed)
- clinical bowel obstruction
- anticipated into another clinical trial within three months
- uncontrolled infection, serious internal medical diseases
- Pregnant or lactating women
- mentally abnormal patients
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 |
|---|---|---|
| curative resection for colorectal cancerAlso: curative resection for colorectal cancer.right hemicolectomy for right colon cancer, transverse colectomy for transverse colon cancer, left hemicolectomy for left colon cancer, sigmoid colectomy for sigmoid colon cancer, and anterior resection or abdominal-perineal resection for rectal cancer. | Procedure or surgery | ARM A- surgery alone, ARM B surgery plus chemotherapy |
| intra-operative 5-FU chemotherapyAlso: intra-operative 5-FU chemotherapy for colorectal cancer5-FU, 1000 mg/m2, injection into bowel lumen at the beginning of resection 5-FU, 200 mg/m2, injection into portal vein via mesentery vein at the end of tumor removal and bowel reconstruction. 5-FU, 300 mg/m2, left in abdominal cavity before incision closure. surgical procedures will be the same as described in ARM A. | Drug | ARM B surgery plus chemotherapy |
Primary outcome
disease-free survival
Time frame: 3 years
3 years survival of recurrence-free, metastasisi-free, death-free after randomization.
2 secondary outcomes
disease-free survival
Time frame: 5 years
safety profiles
Time frame: 28 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Derived from this study: PubMed 28849265Zhang RX, Lin JZ, Lei J, Chen G, Li LR, Lu ZH, Ding PR, Huang JQ, Kong LH, Wang FL, Li C, Jiang W, Ke CF, Zhou WH, Fan WH, Liu Q, Wan DS, Wu XJ, Pan ZZ. Safety of intraoperative chemotherapy with 5-FU for colorectal cancer patients receiving curative resection: a randomized, multicenter, prospective, phase III IOCCRC trial (IOCCRC). J Cancer Res Clin Oncol. 2017 Dec;143(12):2581-2593. doi: 10.1007/s00432-017-2489-0. Epub 2017 Aug 28.
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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.
zhizhong pan, MD, PhD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing curative resection for colorectal cancer and intra-operative 5-FU chemotherapy in people with Colorectal Cancer, run by Sun Yat-sen University 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 9 inclusion and 6 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 11 Aug 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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: 3 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 NCT01465451, 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 11 Aug 2016.