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Combining Curcumin With FOLFOX Chemotherapy in Patients With Inoperable Colorectal Cancer

NCT01490996 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2020-01-31

No results posted yet for this study

Summary

Oral curcumin (complex C3, Sabinsa Corp, Utah) will be given to patients with inoperable colorectal metastases who will be commencing standard care oxaliplatin-based (FOLFOX) chemotherapy for up to 12 cycles(approximately 6 months) of treatment.

Primary measurements focus on safety and tolerability. These will be recorded in real-time and report the number and severity of adverse events.

Secondary measurements will include efficacy, (measured by response rate with RECIST and overall survival in months) supported by biomarker analysis.

Conditions

  • Colonic Cancer
  • Metastasis

Interventions

DRUG

Oral complex C3 curcumin + chemotherapy

Daily oral capsule(s)

DRUG

Chemotherapy only

Standard care chemotherapy

Sponsors & Collaborators

  • University of Leicester

    lead OTHER

Principal Investigators

  • Anne L Thomas, PhD FRCS · University of Leicester/University Hospitals Leicester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • United Kingdom

Study Locations

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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 NCT01490996 on ClinicalTrials.gov