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Active Symptom Control Alone or With mFOLFOX Chemotherapy for Locally Advanced/ Metastatic Biliary Tract Cancers

NCT01926236 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2020-01-28

No results posted yet for this study

Summary

The purpose of this study is to determine whether fit patients (with ECOG performance score of 0-1) with advanced biliary tract cancer (ABC) benefit from chemotherapy in the second-line setting (after prior therapy with cisplatin and gemcitabine) in terms of overall survival.

Conditions

Interventions

OTHER

Active Symptom Control

Active Symptom Control: monthly clinical review and active symptom control as needed, including biliary drainage, antibiotics, analgesia, steroids, anti-emetics, other palliative treatment for symptom control, palliative radiotherapy, blood transfusion.

DRUG

L-folinic acid

L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles

DRUG

5 FU

5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles

DRUG

Oxaliplatin

Oxaliplatin 85mg/m2, q 14d, up to 12 cycles

Sponsors & Collaborators

Principal Investigators

  • Juan Valle, Prof · The Christie NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2018-01-05
Completion
2019-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01926236 on ClinicalTrials.gov