Colorectal CancerPhase 2HIPECNCT01628211
Second Look Laparoscopy in Colorectal Cancer
A Phase 2 study testing Laparoscopy, peritonectomy and Folinic Acid in people with Colorectal Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Laparoscopy, peritonectomy and Folinic Acid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2012to Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologic diagnosis colorectal adenocarcinoma
- Mucinous histotype
- Stage I-III
- Radical (R0) surgical resection of primary tumor
- CT scan with contrast showing no evidence of disease recurrence 6 months after primary surgery
- Age ≥ 18 ≤ 65 years
Show all 10Show fewer
- Performance Status ECOG ≤1
- Normal hepatic, renal and hematologic function
- Adjuvant chemotherapy permitted
- Signed informed consent
Who cannot join
- Residual disease after surgical resection of primary tumor
- Distant metastasis
- Active systemic infection
- Chronic cardiovascular illness that would contraindicate abdominal dilatation with pneumoperitoneum
- Concomitant or previous malignancy with 5 years of surgical resection of primary tumor (except for adequately treated non-melanoma skin cancer and in situ cervical cancer)
- Pregnancy or lactation
- Refusal or incapability of providing informed consent
- Impossibility of complying with study schedules and follow-up
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
Naples, 80131
About this study
Official title: Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal Mucinous Carcinoma
The purpose of this study is to evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.
Read the detailed description
Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI > 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI < 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.
- Conditions
- Colorectal Cancer
- Being tested
- Laparoscopy, peritonectomy, Folinic Acid, 5-Fluorouracil, Oxaliplatin
- Keywords
- hyperthermic chemotherapy, intraperitoneal chemotherapy, second-look laparoscopy, peritoneal carcinosis, mucinous colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
second look laparoscopy to evaluate for peritoneal carcinosis
peritonectomyProcedure or surgery
for patients with PCI < 20
Folinic AcidDrug
20 mg/m2 IV given just before HIPEC for patients with PCI < 20
5-FluorouracilDrug
400 mg/m2 IV given just before HIPEC in patients with PCI < 20
OxaliplatinDrug
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20
systemic chemotherapyDrug
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20
| Study group | Role | What they receive |
|---|---|---|
| Second look laparoscopy | Experimental | Second look laparoscopy to evaluate for and treat peritoneal carcinosis Receives: Procedure: Laparoscopy; Procedure: peritonectomy; Drug: Folinic Acid; Drug: 5-Fluorouracil; Drug: Oxaliplatin; Drug: systemic chemotherapy |
| standard follow up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: two years
Secondary outcomes (6)
number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm
Measured: 6 months
changes in quality of life
quality of life is measured at baseline and 6 months after randomization
Measured: 6 months
overall survival
Measured: five years
worst grade adverse event per patient
toxicity measured only in experimental arm, weekly from randomization to 30 days after experimental treatment
Measured: 7 months
number of patients with radiologic evidence of disease after initial surgery
Measured: 6 months
list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery
description of therapies and outcomes for those patients who were not randomized due to presence of disease
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- C. Sassaroli, M.D., Principal investigator, National Cancer Institute, NaplesA Cassata, M.D., Principal investigator, University of Campania Luigi VanvitelliM.C. Piccirillo, M.D., Principal investigator, NCI Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628211
- Sponsor's protocol ID
- HIPEC
- Acronym
- HIPEC
- Status last verified
- Mar 2023
- First submitted
- 20 Jun 2012
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study Comparing Second Look Laparoscopy to Standard Follow up in Patients With no Radiologic Evidence of Disease at 6 Months After Complete Resection of Colorectal Mucinous Carcinoma
- ClinicalTrials.gov ID
- NCT01628211
- Acronym / sponsor ID
- HIPEC / HIPEC
- Conditions
- Colorectal Cancer
- Keywords
- hyperthermic chemotherapy, intraperitoneal chemotherapy, second-look laparoscopy, peritoneal carcinosis, mucinous colorectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Jun 2012 (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 evaluate whether a second-look laparoscopy, followed by peritonectomy, hyperthermic intraperitoneal chemotherapy (HIPEC) or systemic chemotherapy in case of peritoneal carcinosis, improves the overall survival of patients who have had radical resection of mucinous colorectal cancer.
Detailed description
Patients will be entered into the study after radical resection of mucinous colorectal cancer, and reevaluated by CT scan after 6 months. Patients with no evidence of disease will be randomized to receive either standard follow up, or to have a second look laparoscopy to evaluate for peritoneal carcinosis. After laparoscopy, those patients who do not have peritoneal carcinosis will continue with standard follow up. Patients with peritoneal carcinosis diagnosed by laparoscopy will be treated according to their peritoneal carcinosis index (PCI). For patients with PCI > 20, systemic chemotherapy will be given according to Italian Association of Medical Oncology (AIOM) guidelines. Patients with PCI < 20 will undergo peritonectomy and then receive intravenous chemotherapy immediately followed by HIPEC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Second look laparoscopy | Experimental | Procedure: Laparoscopy, Procedure: peritonectomy, Drug: Folinic Acid, Drug: 5-Fluorouracil, Drug: Oxaliplatin, Drug: systemic chemotherapySecond look laparoscopy to evaluate for and treat peritoneal carcinosis |
| standard follow up | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologic diagnosis colorectal adenocarcinoma
- Mucinous histotype
- Stage I-III
- Radical (R0) surgical resection of primary tumor
- CT scan with contrast showing no evidence of disease recurrence 6 months after primary surgery
Key exclusion criteria (8 listed)
- Residual disease after surgical resection of primary tumor
- Distant metastasis
- Active systemic infection
- Chronic cardiovascular illness that would contraindicate abdominal dilatation with pneumoperitoneum
- Concomitant or previous malignancy with 5 years of surgical resection of primary tumor (except for adequately treated non-melanoma skin cancer and in situ cervical cancer)
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 |
|---|---|---|
| Laparoscopysecond look laparoscopy to evaluate for peritoneal carcinosis | Procedure or surgery | Second look laparoscopy |
| peritonectomyfor patients with PCI < 20 | Procedure or surgery | Second look laparoscopy |
| Folinic Acid20 mg/m2 IV given just before HIPEC for patients with PCI < 20 | Drug | Second look laparoscopy |
| 5-Fluorouracil400 mg/m2 IV given just before HIPEC in patients with PCI < 20 | Drug | Second look laparoscopy |
| Oxaliplatin460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20 | Drug | Second look laparoscopy |
| systemic chemotherapyaccording to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20 | Drug | Second look laparoscopy |
Primary outcome
overall survival
Time frame: two years
6 secondary outcomes
number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm
Time frame: 6 months
changes in quality of life
Time frame: 6 months
overall survival
Time frame: five years
worst grade adverse event per patient
Time frame: 7 months
number of patients with radiologic evidence of disease after initial surgery
Time frame: 6 months
list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
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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.
C. Sassaroli, M.D. principal investigator
National Cancer Institute, Naples
A Cassata, M.D. principal investigator
University of Campania Luigi Vanvitelli
M.C. Piccirillo, M.D. principal investigator
NCI Naples
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 Laparoscopy, peritonectomy and Folinic Acid in people with Colorectal Cancer, run by National Cancer Institute, Naples at 1 site in Italy.
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 10 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: status not confirmed, as of the sponsor's last update on 24 Mar 2023. 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 Italy. 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 Francesco Perrone, M.D., Ph.D. (+39 081 5903571, francesco.perrone@usc-intnapoli.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: two 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 24 Mar 2023.