Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4NCT02179489
Surgery With HIPEC in Treating Patients With a High Risk of Developing Colorectal Peritoneal Carcinomatosis
A study testing Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC in people with Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 and Peritoneal Carcinomatosis, run by Zhejiang University at 9 sites in China.
Trial summary
Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, Peritoneal Carcinomatosis
- What is being tested?
- Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 271 participants
- Where
- 9 sitesChina
- Study dates
- 1 Nov 2014to 30 Nov 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with the following history:
- Histologically-proven colorectal adenocarcinoma
- Presenting at the time of resection of the primary with one of the following 5 criteria (criteria indicating a high risk of developing PC) :
- Minimal PC, resected at the same time as the primary
- Rupture of the primary tumour inside the peritoneal cavity,
- Intraoperative rupture of the primary tumour during surgery
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- Histologically-proven T4 colorectal adenocarcinoma
- Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
- Chemotherapy with FOLFOX4, mFOLFOX6, CapeOx or Capecitabine(the current standard treatment; it can be modified in the future in the two groups, if the standard is modified)
- Given on an intent-to-treat basis (it can be stopped prematurely for miscellaneous reasons)
- Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy
- Patients with the following general characteristics:
- Age between 18 and 75 years
- Performance Status (ECOG) 0, 1 or 2, life expectancy > 12 weeks
- Adequate renal, and bone marrow function: a. Leukocytes >/= 3,000/microL; b. Absolute neutrophil count >/= 1,500/microL; c. Platelets >/= 100,000/Ul; d. Serum creatinine </= 1.5 mg/dL
- Hepatic function: a. AST (SGOT)/ALT (SGPT) </= 5 X institutional (Upper Limit of Normal) ULN
- Operable patients
- Completion of neoadjuvant systemic chemotherapy
- Patients will be informed and a signed consent before initiating any procedure specific to the trial
Who cannot join
- Cancers of non colorectal origin
- Patients presenting with a detectable recurrent tumour
- History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
- Known HIV, Hepatitis B or Hepatitis C positive
- Pregnant women or likely to be pregnant
- Persons under guardianship
- Subjects deemed unable to comply with study and/or follow-up procedures.
- Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Union Hospital Fujian Medical University
Fuzhou, Fujian, 350001
The First Affiliated Hospital of College of Medicine Zhejiang University
Hangzhou, Zhejiang, 310003
Second Affiliated Hospitalof Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Jinhua People's Hospital
Jinhua, Zhejiang, 321000
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
People's Hospital of Shaoxing
Shaoxing, Zhejiang, 312000
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
Yuyao People's Hospital
Yuyao, Zhejiang, 315400
About this study
Official title: Randomized Multicentric Phase III Trial Comparing Simple Surgery to Surgery Plus HIPEC (Hyperthermic Intraperitoneal Chemotherapy) With MMC in Colorectal Patients Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied.
Read the detailed description
Hyperthermic intraperitoneal chemotherapy(HIPEC) is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program demonstrated a significant improvement of overall survival of the disease. It is not yet known whether surgery followed by HIPEC is effective on decreasing the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer.Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC), defined by Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or identified T4 by intraoperative pathological diagnosis, or Tumour Rupture in the Abdominal Cavity. If patients with a high risk of developing PC identified by preoperative examination, they will be informed and will sign the consent. After complete resection of their tumor, they will be randomised to surveillance alone (control group) or HIPEC (experimental group). All patients will receive the current standard postoperative adjuvant treatment : 6 months of systemic chemotherapy (currently including FOLFOX4, mFOLFOX6, CapeOx or Capecitabine regimen which could be modified if the standard is modified). Then a work-up is done to find recurrence. If the recurrence occurs, the patient will be treated with the best known treatment.
- Conditions
- Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, Peritoneal Carcinomatosis
- Being tested
- Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC
- Keywords
- Peritoneal carcinomatosis, HIPEC, controlled clinical trial, colorectal cancer
- Medical subject headings
- Peritoneal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMCProcedure or surgery
HIPEC with MMC: Mitomycin C (MMC) (30 mg/m2 of body surface area). Closed technique, as preferred. Duration: 60 minutes. Mean Intra-abdominal Temperature: 43°C.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | surgery alone |
| Hipec | Experimental | Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC Receives: Procedure: Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
DFS
Measured: Three years from the date of randomization
Secondary outcomes (5)
3 year overall survival
3-OS
Measured: 3 years
Peritoneal disease-free survival
PDFS
Measured: 3 years
5 year overall survival
5-OS
Measured: 5 years
morbidity
Toxicity induced by HIPEC using the NCI CTC criteria; one month and six months morbidity.
Subgroup analysis: pT4; pts. ≤ 40yrs.
Measured: Baseline before any treatment,3 months post operation, 1 year post operation
QOL
Duration of operation; return of bowel function; length of hospital stay; return to normal activity; six months and one year QOL, using the SF-36 v1.0; percentage of patients in both arms completing the scheduled postoperative chemotherapy; Subgroup analysis: pT4; pts. ≤ 40yrs.
Measured: Baseline before any treatment,3 months post operation, 1 year post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2014 (estimated)
- Study start1 Nov 2014
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4Studies of the same condition, open and under way.
- More trials run by Zhejiang 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
- Investigators
- Kefeng Ding, Prof., Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179489
- Sponsor's protocol ID
- CRCCZ-C01
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2014
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicentric Phase III Trial Comparing Simple Surgery to Surgery Plus HIPEC (Hyperthermic Intraperitoneal Chemotherapy) With MMC in Colorectal Patients Who Have a High Risk of Developing Colorectal Peritoneal Carcinomatosis
- ClinicalTrials.gov ID
- NCT02179489
- Acronym / sponsor ID
- CRCCZ-C01
- Conditions
- Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4, Peritoneal Carcinomatosis
- Keywords
- Peritoneal carcinomatosis, HIPEC, controlled clinical trial, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 1 Jul 2014 (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.
Multicentric randomised trial. The goal of this clinical research study is to learn if hyperthermic intraperitoneal chemotherapy (HIPEC) will help to decrease the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer. The safety of this treatment will also be studied.
Detailed description
Hyperthermic intraperitoneal chemotherapy(HIPEC) is a recently validated option for the treatment of peritoneal carcinomatosis from colorectal or ovarian origin. This therapeutic program demonstrated a significant improvement of overall survival of the disease. It is not yet known whether surgery followed by HIPEC is effective on decreasing the rate of peritoneal carcinomatosis(PC) in patients with high risk of developing PC of colorectal cancer.Patients with a high risk of developing colorectal Peritoneal Carcinomatosis (PC), defined by Colorectal Cancer With a Resected Minimal Synchronous PC or Ovarian Metastases, or identified T4 by intraoperative pathological diagnosis, or Tumour Rupture in the Abdominal Cavity. If patients with a high risk of developing PC identified by preoperative examination, they will be informed and will sign the consent. After complete resection of their tumor, they will be randomised to surveillance alone (control group) or HIPEC (experimental group). All patients will receive the current standard postoperative adjuvant treatment : 6 months of systemic chemotherapy (currently including FOLFOX4, mFOLFOX6, CapeOx or Capecitabine regimen which could be modified if the standard is modified). Then a work-up is done to find recurrence. If the recurrence occurs, the patient will be treated with the best known treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –surgery alone |
| Hipec | Experimental | Procedure: Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMCSurgery and Hyperthermic Intraperitoneal Chemotherapy with MMC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients presenting with the following history:
- Who have received standard systemic adjuvant chemotherapy (6 months of systemic chemotherapy) :
- Patients who do not present any sign of tumour recurrence at the end of these 6 months of chemotherapy
- Patients with the following general characteristics:
- Patients will be informed and a signed consent before initiating any procedure specific to the trial
Key exclusion criteria (8 listed)
- Cancers of non colorectal origin
- Patients presenting with a detectable recurrent tumour
- History of cancer (excepted cutaneous basal cell carcinoma or in situ carcinoma of the uterine cervix) with a recurrence during the 5 previous years
- Known HIV, Hepatitis B or Hepatitis C positive
- Pregnant women or likely to be pregnant
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 |
|---|---|---|
| Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMCHIPEC with MMC: Mitomycin C (MMC) (30 mg/m2 of body surface area). Closed technique, as preferred. Duration: 60 minutes. Mean Intra-abdominal Temperature: 43°C. | Procedure or surgery | Hipec |
Primary outcome
Disease-free survival
Time frame: Three years from the date of randomization
DFS
5 secondary outcomes
3 year overall survival
Time frame: 3 years
Peritoneal disease-free survival
Time frame: 3 years
5 year overall survival
Time frame: 5 years
morbidity
Time frame: Baseline before any treatment,3 months post operation, 1 year post operation
QOL
Time frame: Baseline before any treatment,3 months post operation, 1 year post operation
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 27 Jun 2022.
- Individual participant dataSharing planned: No
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.
Kefeng Ding, Prof. principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC in people with Malignant Neoplasm of Large Intestine TNM Staging Primary Tumor (T) T4 and Peritoneal Carcinomatosis, run by Zhejiang University at 9 sites 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 19 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: finished, as of the sponsor's last update on 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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?
Disease-free survival (time frame: Three years from the date of randomization). 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 27 Jun 2022.