Stomach NeoplasmsPhase 2IPHCNCT00454519
Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy (IPHC) to Treat Peritoneal Carcinomatosis
A Phase 2 study testing cytoreductive surgery and intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin in people with Stomach Neoplasms and Colorectal Neoplasms, run by Wuhan University at 1 site in China.
Trial summary
OBJECTIVES: Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin Assess the quality of life of patients treated with this regimen. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stomach Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis
- What is being tested?
- cytoreductive surgery and intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Mar 2007to Dec 2009
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- Gastric cancer or colorectal cancer with malignant ascites
- Karnofsky Performance Scale(KPS)>50
Who cannot join
- Age less than 20 years old, or beyond 70 years old
- Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis
- Bilirubin greater than 3 times upper limit of normal (ULN)
- AST and ALT greater than 5 times ULN
- Liver enzymes greater than 3 times ULN
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Center of Wuhan University & Department of Oncology, Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Yan Li, M.D., Ph.D, +86-27-67813152 ext. 3152, liyansd2@163.com
Yonemura Yutaka, M.D., Ph.D, +81-072-433-2131, y.yonemura@coda.ocn.ne.jp
About this study
Official title: Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial
OBJECTIVES:
- Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- Assess the quality of life of patients treated with this regimen.
Read more
OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery.
All patients in both groups receive the standard conventional chemotherapy after surgery.
Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.
Read the detailed description
DISEASE CHARACTERISTICS:
- Histologically confirmed peritoneal carcinomatosis with the following histologies:
- Primary peritoneal mesothelioma
- Adenocarcinoma of gastrointestinal tract origin
- Confined to peritoneal cavity
- Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit
- Must not have failed prior intraperitoneal platinum therapy
- Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy
PATIENT CHARACTERISTICS:
Age:
- 20 to 70 years old
Performance status:
- KPS>50
Life expectancy:
- More than 8 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 80,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT no greater than 2 times ULN
- Liver enzymes no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No significant irreversible cardiac ischemia
- No significant changes in ECG recording
Pulmonary:
- FEV_1 at least 1.2 liters
- Maximum voluntary ventilation at least 50% expected
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent medical problems that would preclude surgery
- Being tested
- cytoreductive surgery, intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- Keywords
- peritoneal carcinomatosis, cisplatin, mitomycin, gastric cancer, colorectal cancer
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms, Neoplasm Metastasis, Mesothelioma, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytoreductive surgeryProcedure or surgery
the whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible.
intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycinProcedure or surgery
Also called HIPEC
Immediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | cytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy. Receives: Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin |
| B | Active comparator | cytoreductive surgery alone, postoperative chemotherapy. Receives: Procedure: cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival time
Measured: from operation to death due to cancer recurrence
Secondary outcomes (1)
perioperative morbidity and mortality
Measured: Within 30 days postoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- NPO Organization to Support Peritoneal Dissemination Treatment, Kishiwada Tokushukai Hospital, Kusatsu General Hopital, Ikeda Hospital
- Investigators
- Yan Li, M.D., Ph.D, Principal investigator, Cancer Center of Wuhan UniversityYonemura Yutaka, MD, PhD, Principal investigator, NPO Organization to Support Peritoneal Dissemination Treatment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454519
- Sponsor's protocol ID
- WUCC-0701
- Acronym
- IPHC
- Status last verified
- Feb 2009
- First submitted
- 29 Mar 2007
- Last updated
- 13 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19.
PubMed 19018599Zou D, Cai Y, Jin M, Zhang M, Liu Y, Chen S, Yang S, Zhang H, Zhu X, Huang C, Zhu Y, Miao X, Wei Y, Yang X, Tian J. A genetic variant in the immune-related gene ERAP1 affects colorectal cancer prognosis. Chin Med J (Engl). 2024 Feb 20;137(4):431-440. doi: 10.1097/CM9.0000000000002845. Epub 2023 Sep 8.
PubMed 37690994Wu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.
PubMed 27633880
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytoreductive Surgery Plus Intraoperative Peritoneal Hyperthermic Chemotherapy for the Treatment of Peritoneal Carcinomatosis From Gastrointestinal Cancer: an Open Label, Randomized, Prospective, Phase 2 Clinical Trial
- ClinicalTrials.gov ID
- NCT00454519
- Acronym / sponsor ID
- IPHC / WUCC-0701
- Keywords
- peritoneal carcinomatosis, cisplatin, mitomycin, gastric cancer, colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Collaborators
- NPO Organization to Support Peritoneal Dissemination Treatment, Kishiwada Tokushukai Hospital, Kusatsu General Hopital, Ikeda Hospital
- Study start
- Mar 2007
- Primary completion
- Dec 2009 (estimated)
- First posted
- 30 Mar 2007 (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.
OBJECTIVES:
- Determine response and survival of patients with peritoneal carcinomatosis treated with cytoreductive surgery plus intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients are randomized into IPHC group and control group. In the former group, the patients undergo cytoreductive surgery plus intraoperative hyperthermic peritoneal perfusion with cisplatin and mitomycin over 60 minutes. Patients in the control group just underwent routine cytoreductive surgery.
All patients in both groups receive the standard conventional chemotherapy after surgery.
Quality of life is assessed at study initiation, at 1, 3, 6 months. Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for up to 3 years.
Detailed description
DISEASE CHARACTERISTICS:
- Histologically confirmed peritoneal carcinomatosis with the following histologies:
- Primary peritoneal mesothelioma
- Adenocarcinoma of gastrointestinal tract origin
- Confined to peritoneal cavity
- Tumor mass could be debulked to less than 2.5 cm in diameter per tumor deposit
- Must not have failed prior intraperitoneal platinum therapy
- Treatment failure is defined as radiographic evidence of disease progression on 2 consecutive CT scans within 3 months after therapy
PATIENT CHARACTERISTICS:
Age:
- 20 to 70 years old
Performance status:
- KPS>50
Life expectancy:
- More than 8 weeks
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 80,000/mm^3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT no greater than 2 times ULN
- Liver enzymes no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No significant irreversible cardiac ischemia
- No significant changes in ECG recording
Pulmonary:
- FEV_1 at least 1.2 liters
- Maximum voluntary ventilation at least 50% expected
Other:
- Not pregnant or nursing
- Negative pregnancy test
- No concurrent medical problems that would preclude surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycincytoreductive surgery, IPHC, cisplatin 20 mg/m2/L, Mitomycin C 4 mg/m2/L, postoperative chemotherapy. |
| B | Active comparator | Procedure: cytoreductive surgerycytoreductive surgery alone, postoperative chemotherapy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gastric cancer or colorectal cancer with peritoneal carcinomatosis
- Gastric cancer or colorectal cancer with malignant ascites
- Karnofsky Performance Scale(KPS)>50
Key exclusion criteria (5 listed)
- Age less than 20 years old, or beyond 70 years old
- Any lung metastasis, liver metastasis, or prominent retroperitoneal lymph node metastasis
- Bilirubin greater than 3 times upper limit of normal (ULN)
- AST and ALT greater than 5 times ULN
- Liver enzymes greater than 3 times ULN
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 |
|---|---|---|
| cytoreductive surgerythe whole abdominal-pelvic cavity is explored and maximal cytoreductive surgery is performed to remove visible tumor burden as much as possible. | Procedure or surgery | B |
| intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycinAlso: HIPECImmediately after the cytoreductive surgery, cisplatin and mitomycin C dissolved in 12,000 ml of normal saline heated to 42 degrees celsius is infused into the abdominal cavity for a sustained hyperthermic intraperitoneal chemotherapy for 60 to 90 minutes. | Procedure or surgery | A |
Primary outcome
overall survival time
Time frame: from operation to death due to cancer recurrence
1 secondary outcome
perioperative morbidity and mortality
Time frame: Within 30 days postoperation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2009.
- Background: PubMed 19018599Yang XJ, Li Y, al-shammaa Hassan AH, Yang GL, Liu SY, Lu YL, Zhang JW, Yonemura Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy improves survival in selected patients with peritoneal carcinomatosis from abdominal and pelvic malignancies: results of 21 cases. Ann Surg Oncol. 2009 Feb;16(2):345-51. doi: 10.1245/s10434-008-0226-2. Epub 2008 Nov 19.
- Derived from this study: PubMed 37690994Zou D, Cai Y, Jin M, Zhang M, Liu Y, Chen S, Yang S, Zhang H, Zhu X, Huang C, Zhu Y, Miao X, Wei Y, Yang X, Tian J. A genetic variant in the immune-related gene ERAP1 affects colorectal cancer prognosis. Chin Med J (Engl). 2024 Feb 20;137(4):431-440. doi: 10.1097/CM9.0000000000002845. Epub 2023 Sep 8.
- Derived from this study: PubMed 27633880Wu HT, Yang XJ, Huang CQ, Sun JH, Ji ZH, Peng KW, Zhang Q, Li Y. Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy with lobaplatin and docetaxel improves survival for patients with peritoneal carcinomatosis from abdominal and pelvic malignancies. World J Surg Oncol. 2016 Sep 15;14(1):246. doi: 10.1186/s12957-016-1004-4.
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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.
Yan Li, M.D., Ph.D principal investigator
Cancer Center of Wuhan University
Yonemura Yutaka, MD, PhD principal investigator
NPO Organization to Support Peritoneal Dissemination Treatment
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 cytoreductive surgery and intraoperative peritoneal hyperthermic chemotherapy with cisplatin and mitomycin in people with Stomach Neoplasms and Colorectal Neoplasms, 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 3 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: status not confirmed, as of the sponsor's last update on 13 Feb 2009. 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 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 Yan Li, M.D., Ph.D (+86-27-62337478, liyansd2@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival time (time frame: from operation to death due to cancer recurrence). 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 NCT00454519, which also lists 3 linked publications.
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 Feb 2009.