Clinical trial NCT01628211: Second Look Laparoscopy in Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: hyperthermic chemotherapy
intraperitoneal chemotherapy
second-look laparoscopy
peritoneal carcinosis
mucinous colorectal cancer
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* Performance Status ECOG ≤1
* Normal hepatic, renal and hematologic function
* Adjuvant chemotherapy permitted
* Signed informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: overall survival
timeFrame: two years
Secondary outcomes:
measure: number of patients with peritoneal carcinosis diagnosed at laparoscopy in the experimental arm
timeFrame: 6 months
measure: changes in quality of life
timeFrame: 6 months
measure: overall survival
timeFrame: five years
measure: worst grade adverse event per patient
timeFrame: 7 months
measure: number of patients with radiologic evidence of disease after initial surgery
timeFrame: 6 months
measure: list of therapies and clinical outcomes of patients who had radiologic evidence of disease within 6 months after initial surgery
timeFrame: two years
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori , Oncologia Medica - Dipartimento Entero-proctologico
Study officials:
affiliation: National Cancer Institute, Naples
name: C. Sassaroli, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campania Luigi Vanvitelli
name: A Cassata, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NCI Naples
name: M.C. Piccirillo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: