Combined Neoadjuvant Systemic and PIPAC Therapy (NASPIT) for Patients With Colorectal Peritoneal Metastasis Eligible for CRS and HIPEC: A Prospective Phase II Trial

Metastatic Colorectal Cancer Clinical Trial

Official title: Combined Neoadjuvant Systemic and PIPAC Therapy (NASPIT) for Patients With Colorectal Peritoneal Metastasis Eligible for CRS and HIPEC: A Prospective Phase II Trial

Status Not yet recruiting

Clinical Trial Summary

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is a novel drug-delivery system developed to deliver, effectively and safely, small doses of cytotoxic agents into peritoneal tumor deposits. It is currently used for palliation and for down-staging of patients who are non-eligible for cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy (HIPEC).

The aim of this study is to evaluate the efficacy of PIPAC used in neoadjuvant setting to enhance the response of patients with colorectal peritoneal metastasis when combined with neoadjuvant systemic therapy for patients eligible to CRS/HIPEC prior to planned surgery.

Clinical Trial Description

This is an open label, single arm, single center, phase II trial to study the added efficacy benefit of PIPAC administered in the neoadjuvant setting in combination with systemic therapy for patients eligible for CRS/HIPEC.

the following procedures will be done to all study population. Visit 0 (Week #0) screening - Clinical evaluation and baseline cross-sectional imaging. Patients will be evaluated for their eligibility and recruited if found suitable.

(Week #1) tumor board discussion to ensure eligibility and staging (Week #2-4) Initiation of systemic therapy, if not been already started (2 cycles): Systemic therapy will be administered and tailored by the treating oncologist as per patient tolerability. If already on chemotherapy at visit 0, patients will continue chemotherapy until first PIPAC.

Visit 1 (Week #4) first PIPAC: Diagnostic laparoscopy, staging, PCI evaluation and biopsies will be taken as described earlier.

Systemic therapy (2 cycles, Week #4-8): Systemic therapy will be administered and tailored by the treating oncologist as per patient tolerability.

Visit 2 (Week #6) - post first PIPAC - Surgical Oncology Clinic: evaluation of PIPAC tolerability and possible side effects or complications. Cross sectional imaging to monitor progression prior to the upcoming second PIPAC.

Visit 3 (Week #8) - second PIPAC: Diagnostic laparoscopy, staging, PCI evaluation and biopsies will be taken as described earlier.

Systemic therapy (2 cycles, Week #8-12): Systemic therapy will be administered and tailored by the treating oncologist as per patient tolerability. Systemic therapy will be stopped at week#12 (2-4 weeks) prior to planned CRS/HIPEC Visit 4 (Week #10) - post second PIPAC - Surgical Oncology Clinic: evaluation of PIPAC tolerability, quality of life, and possible side effects or complications after PIPAC.

Visit 5 (Week #12-14) - Surgical evaluation and cross-sectional imaging - Surgical Oncology Clinic: Planning for upcoming CRS/HIPEC Visit 6 (Week #14-16) - CRS/HIPEC: proper PCI evaluation, complete tumor cytoreduction and HIPEC will be targeted. The extent of surgery, technical difficulties including OR time and blood loss will be documented.

Visit 7 follow up visit: will be conducted within 1 month after hospital discharge. Tolerability and possible complications post-surgery will be evaluated.

Visit 8-11 follow up visits: Surgical Oncology Clinic evaluation: cross sectional imaging, Tumor markers and clinical evaluation will be conducted for any signs of possible recurrence on 3 monthly bases Visit 12-13 follow up: Surgical oncology clinic: cross sectional imaging, Tumor markers and clinical evaluation will be conducted for any signs of possible recurrence on 6 monthly bases. The follow up for the trial will be concluded at this stage (total of 3 years follow up).

To be noted that patient systemic chemotherapy would not be interrupted throughout the treatment protocol and PIPAC therapy will be delivered in-between chemotherapy cycles. ;

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma
• Colon Adenocarcinoma
• Metastatic Colorectal Cancer
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms

• NCT number: NCT04475159
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Gal Levi, M.Sc
• Phone: 972-3-5307595
• Email: gal.levi@sheba.gov.il
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 1, 2020
• Completion date: August 1, 2023