Malignant Neoplasm of ColorectumPhase 2NCT02830139
Radical Colorectal Resection and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Colorectal Cancer
A Phase 2 study testing Hyperthermic intraperitoneal chemotherapy (HIPEC), Radical colorectal resection and Oxaliplatin , Capecitabine in people with Malignant Neoplasm of Colorectum, run by Wuhan University at 1 site in China.
Trial summary
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasm of Colorectum
- What is being tested?
- Hyperthermic intraperitoneal chemotherapy (HIPEC), Radical colorectal resection and Oxaliplatin , Capecitabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to 15 Mar 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histological proved diagnosis of locally advanced colorectal cancer.
- No evidence of distant metastases or peritoneal metastases.
- Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
- Eligible for radical colorectal resection with lymphadenectomy.
- Have not received cytotoxic chemotherapy or radiotherapy.
- Written informed consent is obtained prior to commencement of trial treatment.
Who cannot join
- Existence of distant metastasis or peritoneal metastasis during surgery (M1).
- Any previous chemotherapy or radiotherapy
- Active systemic infections
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.
Read the detailed description
To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
- Conditions
- Malignant Neoplasm of Colorectum
- Being tested
- Hyperthermic intraperitoneal chemotherapy (HIPEC), Radical colorectal resection, Oxaliplatin , Capecitabine, Normal saline , Cisplatin , 5-Fu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperthermic intraperitoneal chemotherapy (HIPEC)Procedure or surgery
Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.
Radical colorectal resectionProcedure or surgery
radical colorectal resection with lymphadenectomy
Oxaliplatin , CapecitabineDrug
XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Normal saline , Cisplatin , 5-FuDrug
| Study group | Role | What they receive |
|---|---|---|
| Radical colorectal resection without HIPEC | Sham comparator | Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX) Receives: Procedure: Radical colorectal resection; Drug: Oxaliplatin , Capecitabine; Drug: Normal saline , Cisplatin , 5-Fu |
| Radical colorectal resection with HIPEC | Experimental | Patients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX) Receives: Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC); Procedure: Radical colorectal resection; Drug: Oxaliplatin , Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
From the date of surgery to the date of death or to the end of follow-up
Measured: 5 years
Secondary outcomes (5)
progression-free survival
Measured: 5 years
distant metastasis rate
Measured: 5 years
peritoneal metastasis rate
Measured: 5 years
local recurrence rate
Measured: 5 years
complication rate
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 posted12 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of ColorectumStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bin Xiong, MD, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830139
- Sponsor's protocol ID
- WuhanU_HIPEC_colon
- Status last verified
- Mar 2020
- First submitted
- 8 Jul 2016
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in the Treatment of Locally Advanced Colorectal Cancer During Radical Colorectal Resection
- ClinicalTrials.gov ID
- NCT02830139
- Acronym / sponsor ID
- WuhanU_HIPEC_colon
- Conditions
- Malignant Neoplasm of Colorectum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 12 Jul 2016 (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 efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced colorectal cancer is not definite. The hypothesis of the trial is that radical colorectal resection plus HIPEC is superior to only radical colorectal resection in terms of overall survival.
Detailed description
To determine the efficacy of HIPEC in the treatment of locally advanced colorectal cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical colorectal resection with lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical colorectal resection with lymphadenectomy. Patients in both groups receive 8 cycles of postoperative chemotherapy (XELOX) and are followed up for 5 years or until death.
The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical colorectal resection without HIPEC | Sham comparator | Procedure: Radical colorectal resection, Drug: Oxaliplatin , Capecitabine, Drug: Normal saline , Cisplatin , 5-FuPatients will be treated with a radical colorectal resection for locally advanced colorectal cancer and postoperative chemotherapy (XELOX) |
| Radical colorectal resection with HIPEC | Experimental | Procedure: Hyperthermic intraperitoneal chemotherapy (HIPEC), Procedure: Radical colorectal resection, Drug: Oxaliplatin , CapecitabinePatients will be treated with a radical colorectal resection for locally advanced colorectal cancer and HIPEC with paclitaxel and 5-Fu and postoperative chemotherapy (XELOX) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histological proved diagnosis of locally advanced colorectal cancer.
- No evidence of distant metastases or peritoneal metastases.
- Preoperative examination (CT/MRI) demonstrated resectable colorectal cancer with T3-T4 stage.
- Eligible for radical colorectal resection with lymphadenectomy.
- Have not received cytotoxic chemotherapy or radiotherapy.
Key exclusion criteria (5 listed)
- Existence of distant metastasis or peritoneal metastasis during surgery (M1).
- Any previous chemotherapy or radiotherapy
- Active systemic infections
- Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial.
- Female patients who are pregnant or breast feeding
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 |
|---|---|---|
| Hyperthermic intraperitoneal chemotherapy (HIPEC)Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery. | Procedure or surgery | Radical colorectal resection with HIPEC |
| Radical colorectal resectionradical colorectal resection with lymphadenectomy | Procedure or surgery | Radical colorectal resection with HIPEC, Radical colorectal resection without HIPEC |
| Oxaliplatin , CapecitabineXELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14. | Drug | Radical colorectal resection with HIPEC, Radical colorectal resection without HIPEC |
| Normal saline , Cisplatin , 5-Fu | Drug | Radical colorectal resection without HIPEC |
Primary outcome
overall survival
Time frame: 5 years
From the date of surgery to the date of death or to the end of follow-up
5 secondary outcomes
progression-free survival
Time frame: 5 years
distant metastasis rate
Time frame: 5 years
peritoneal metastasis rate
Time frame: 5 years
local recurrence rate
Time frame: 5 years
complication rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
Related trials for Malignant Neoplasm of Colorectum
Recruiting
ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study
Colorectal Neoplasm, Endoscopic Mucosal Resection
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 Hyperthermic intraperitoneal chemotherapy (HIPEC), Radical colorectal resection and Oxaliplatin , Capecitabine in people with Malignant Neoplasm of Colorectum, run by Wuhan 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 18 Mar 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 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall survival (time frame: 5 years). 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 18 Mar 2020.