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INTERACT-PLUS trial

Acronym

INTERACT-PLUS trial

Name of the study

Neo-adjuvant intraperitoneal chemotherapy (irinotecan) combined with systemic chemotherapy (mFOLFOX-4 and bevacizumab) prior to cytoreductive surgery and HIPEC for patients with isolated resectable colorectal peritoneal metastases. A phase II, multicentre study.

Researchers and contact information

Erasmus Medical Center (Sponsor)

Adress: Dr. Molewaterplein 40, 3015 GD Rotterdam

Principal investigator: dr. Eva Madsen

Email: e.madsen@erasmusmc.nl

Name researcher: Julie Hamm

Email: j.hamm@erasmusmc.nl

Tel.: 010-704 29 85

Catharina ziekenhuis Eindhoven

Adress: Michelangelolaan 2, 5623 EJ Eindhoven

Local Investigator: Prof. dr. Ignace De Hingh

Email: Ignace.d.hingh@catharinaziekenhuis.nl

Name researcher: Laskarina Galanos

Email: laskarina.galanos@catharinaziekenhuis.nl

Tel.: +31 40 239 52 64

Antoni van Leeuwenhoek (NKI)

Adress: Plesmanlaan 121, 1066 CX Amsterdam

Local Investigator: dr. Niels Kok

Email: n.kok@nki.nl

Name researcher: Lizzel van der Snee

Email: l.vd.snee@nki.nl

Tel.: 020-5122989

Amsterdam Universitair Medisch Centrum (not open for inclusions)

Adress: Meibergdreef 9, 1105 AZ Amsterdam

Local Investigator: Prof. dr. Jurriaan Tuynman

Email: j.tuynman@amsterdamumc.nl

Name researcher: Lars van Kesteren

Email: l.vankesteren1@amsterdamumc.nl

Tel.: 06-40947115

 

Summary study

Rationale

For colorectal cancer patients with limited peritoneal metastases (PCI<20), the only curative intent treatment option is to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS-HIPEC). Although CRS-HIPEC offers curation for some, recurrence in the peritoneal cavity is very common. Previous research suggests that patients with peritoneal metastases may benefit from additional intraperitoneal (IP) chemotherapy prior to CRS-HIPEC.

Primary objective

Primary endpoint of this phase 2 trial is the feasibility of IP chemotherapy in addition to systemic chemotherapy prior to CRS-HIPEC in patients with resectable PM of colorectal origin.

Study design

Multicenter, single-arm, phase II trial, including 40 patients.

Study population

Adults with a good performance status (WHO), histological/cytological confirmation of a non-appendiceal colorectal carcinoma with <50% signet ring cells in peritoneal deposits or ascites, resectable disease confirmed by laparotomy or laparoscopy, no systemic metastases, no systemic therapy 6 months in the past 6 months, no resection of systemic metastases in the past 6 months, no contraindications for the planned systemic therapy regimens, and no previous cytoreductive surgery with HIPEC.

Secondary endpoints

Secondary endpoints in this trial are histopathological and radiological treatment response, safety of the treatment, the potential value of PET-CT in treatment response monitoring, quality of life (EQ-5D-5L, QLQ-C30, QLQ-CR29, iMTA productivity cost questionnaire, iMTA medical consumption questionnaire) and disease-free survival, which is assessed until six months after CRS-HIPEC. 

 

 

Intervention

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All patients in this trial will receive additional intravenous and IP treatment prior to CRS and HIPEC. According to standard of care in the Netherlands, patients undergo a diagnostic laparoscopy to evaluate the PCI-score. In case of a PCI-score between 1-20, a peritoneal access port for IP administration of irinotecan is placed.

Simultaneously with IP irinotecan, patients receive intravenous 5-fluorouracil/leucovorin with oxaliplatin and bevacizumab. Depending on response and tolerability, patients receive a maximum of six cycles, the last two without bevacizumab.

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