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Assessing Safety of NIPOX in Peritoneal Carcinomatosis of CRC

NCT03253133 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-05-03

No results posted yet for this study

Summary

This study determine the maximal tolerate dose

Conditions

Interventions

DRUG

Oxaliplatin

Dose levels of Oxaliplatin: 4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1 Table 1: Dose levels Dose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 \* 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6 \* Start level

DRUG

LV5FU or Folfiri

Association of chemotherapy by LV5FU or Folfiri according pratician choice

DRUG

Oxycodone

Oxycodone

Sponsors & Collaborators

  • Institut du Cancer de Montpellier - Val d'Aurelle

    lead OTHER

Principal Investigators

  • Olivia Sgarbura · Institut régional du Cancer de Montpellier

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-10
Primary Completion
2020-10-28
Completion
2023-04-24

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253133 on ClinicalTrials.gov