Clinical Pharmacology of Platinum-based Hyperthermic Intraperitoneal Chemotherapy

NCT03364907 | Completed

• 1 other identifier: GUTOX
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there is a lack of knowledge on the effect of additional flushing after HIPEC on tumour platinum exposure, systemic platinum exposure and platinum concentration in drain exudate and thereby personal exposure. Therefore the investigators want to perform a study to investigate the effect of flushing after HIPEC on tumour exposure, systemic exposure and on wound exudate concentration.

Conditions

Peritoneal Carcinomatosis

Keywords

HIPEC; oxaliplatin; flushing; peritoneal carcinomatosis

Outcome Measures

Primary Outcomes (1)

• change in tissue platinum exposure before and after flushing

  Change in tissue platinum exposure of non-tumour peritoneal tissue sample before and after flushing with saline

  immediately after the oxaliplatin instillate solution is withdrawn from the abdominal cavity and immediately after additional flushing is performed. This takes all place within 1 hour after the start of HIPEC.

Secondary Outcomes (3)

• wound exudate platinum concentration

  until day 3 post-HIPEC

• systemic exposure of total and unbound platinum

  until day 3 post-HIPEC

• total and unbound platinum concentration in instillate

  all samples will be taken within 30 minutes during the HIPEC procedure

Study Arms (1)

HIPEC patients

Patients with a diagnosis of peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin.

Other: HIPEC with flushing afterwards; Other: HIPEC without flushing afterwards

Interventions

HIPEC with flushing afterwards OTHER

flushing with saline fluid after HIPEC

HIPEC patients

HIPEC without flushing afterwards OTHER

NO flushing with saline fluid after HIPEC

HIPEC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with peritoneal carcinomatosis who undergo HIPEC treatment with oxaliplatin as part of routine care.

You may qualify if:

• Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow-up.
• Note: Informed consent may be obtained prior to start of the specified screening window.
• Note: Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes.
• Age ≥ 18 years
• Confirmed diagnosis of preoperatively identifi ed primary or recurrent peritoneal carcinomatosis (PC) of colorectal origin who are planned for HIPEC treatment with oxaliplatin according to routine clinical care

You may not qualify if:

• \) Patients who do not achieve a cytoreduction score of CC-0 will be excluded from the study.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (1)

• de Jong LAW, Elekonawo FMK, Lambert M, de Gooyer JM, Verheul HMW, Burger DM, de Wilt JHW, Chatelut E, Ter Heine R, de Reuver PR, Bremers AJA, van Erp NP. Wide variation in tissue, systemic, and drain fluid exposure after oxaliplatin-based HIPEC: results of the GUTOX study. Cancer Chemother Pharmacol. 2020 Jul;86(1):141-150. doi: 10.1007/s00280-020-04107-y. Epub 2020 Jun 27.

  PMID: 32594200 RESULT

Related Links

• paper

Biospecimen

Retention: SAMPLES WITHOUT DNA

peritoneal tissue samples, blood samples, instillate samples and wound exudate samples will be collected from the patients

MeSH Terms

Conditions

Peritoneal Neoplasms; Flushing

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: December 7, 2017
• Study Start: March 1, 2018
• Primary Completion: June 8, 2019
• Study Completion: December 30, 2019
• Last Updated: October 20, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)