Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2012-04-30
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Second look laparoscopy
Second look laparoscopy to evaluate for and treat peritoneal carcinosis
Laparoscopy
second look laparoscopy to evaluate for peritoneal carcinosis
peritonectomy
for patients with PCI \< 20
Folinic Acid
20 mg/m2 IV given just before HIPEC for patients with PCI \< 20
5-Fluorouracil
400 mg/m2 IV given just before HIPEC in patients with PCI \< 20
Oxaliplatin
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI \< 20
systemic chemotherapy
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI \> 20
standard follow up
No interventions assigned to this group
Interventions
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Laparoscopy
second look laparoscopy to evaluate for peritoneal carcinosis
peritonectomy
for patients with PCI \< 20
Folinic Acid
20 mg/m2 IV given just before HIPEC for patients with PCI \< 20
5-Fluorouracil
400 mg/m2 IV given just before HIPEC in patients with PCI \< 20
Oxaliplatin
460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI \< 20
systemic chemotherapy
according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI \> 20
Eligibility Criteria
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Inclusion Criteria
* 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
* Performance Status ECOG ≤1
* Normal hepatic, renal and hematologic function
* Adjuvant chemotherapy permitted
* Signed informed consent
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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C. Sassaroli, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute, Naples
A Cassata, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Campania Luigi Vanvitelli
M.C. Piccirillo, M.D.
Role: PRINCIPAL_INVESTIGATOR
NCI Naples
Locations
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Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
Napoli, , Italy
Countries
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Central Contacts
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Other Identifiers
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HIPEC
Identifier Type: -
Identifier Source: org_study_id
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