Know Cancer

or
forgot password

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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

C. Sassaroli, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute, Naples

Authority:

Italy: Ethics Committee

Study ID:

HIPEC

NCT ID:

NCT01628211

Start Date:

April 2012

Completion Date:

June 2016

Related Keywords:

  • Colorectal Cancer
  • hyperthermic chemotherapy
  • intraperitoneal chemotherapy
  • second-look laparoscopy
  • peritoneal carcinosis
  • mucinous colorectal cancer
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms

Name

Location