Clinical trial

Proactive Management of Endoperitoneal Spread in Colonic Cancer

Name

PROMENADE v1.0

Description

This study aims to determine the oncological effectiveness, compared to standard surgical treatment, of proactive management including target organs for peritoneal spread resection (omentectomy, bilateral adnexectomy, appendectomy, hepatic round ligament resection) and preventive HIPEC (intraperitoneal oxaliplatin with concomitant i.v. 5-fluorouracil/leucovorin) following a curative resection of high-risk ( \>/= 5 mm tumor invasion beyond the muscularis propria) T3 and T4 colon cancer in preventing the development of peritoneal metastases. Adjuvant systemic chemotherapy will be reserved in both groups for patients with poor prognostic factors according to Folinic acid/Fluorouracil/Oxaliplatin (FOLFOX) or to Capecitabine/Oxaliplatin (CAPOX) regimens. Hypothesis: The hypothesis is that compared to the standard treatment proactive management following curative resection of high-risk T3 and T4 colon cancer will reduce the development of endoperitoneal metastases

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-09-01

Trial end

2025-09-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Standard surgical treatment

Standard surgical treatment (open or laparoscopic techniques) containing at least 12 lymph-nodes for accurate pN staging.

Arms:

Standard surgical treatment group

Proactive management

Colon cancer patients (high-risk T3 and T4) without peritoneal or systemic metastases are resected for cure. Simultaneously patients will undergo infracolic omentectomy, appendectomy, exeresis of the liver round ligament and, in women, a bilateral oophorectomy. After positioning three in- and outflow catheters HIPEC perfusion starts with a minimum of 2 L isotonic dialysis fluid at a flow-rate of 1-2 l min and an inflow temperature of 42-43° C with a total of 30 minutes perfusion time. Before the beginning of HIPEC 5-fluouracil and leucovorin will be administrated intravenously to potentiate oxaliplatin activity.

Arms:

Proactive management group

Standard adjuvant systemic chemotherapy

Adjuvant systemic chemotherapy (according CAPOX or FOLFOX regimens for a total of 6 months) will be reserved in patients with pT3 tumors with poor prognostic factors, in patients with pT4 tumors and when lymph-nodes metastases are present. Presence or absence of peritoneal recurrence will be evaluated by MDCT every six months for the first 24 months and later every year for the next three years in both study arms.

Arms:

Proactive management group, Standard surgical treatment group

Other names:

adjuvant capecitabine and oxaliplatin (CAPOX), adjuvant 5-FU and oxaliplatin (FOLFOX)

Size

140

Primary endpoint

Incidence of endoperitoneal recurrence at 36 months

36 months

Eligibility criteria

Inclusion Criteria: * Patients with colon cancer or intraperitoneal rectosigmoid cancer with clinical (by CT) high-risk(\> 5mm) T3, T4 tumors, any N, M0 * Performance Status (ECOG) 0, 1 or 2 * Signed informed consent Exclusion Criteria: * BMI\> 30 * Impossibility of an adequate follow-up * Intra and extraabdominal metastatic disease, multiple colorectal cancer or other malignancies * Active infections or severe associated medical conditions (ASA IV or V) * Abnormal bone marrow or renal and liver function indices

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ESTIMATED'}}

Updated at

2023-05-06

1 organization

1 product

2 indications

Organization

University of Roma La Sapienza

Product

Standard adjuvant systemic chemotherapy

Indication

Colon Cancer

Indication

Rectal Cancer