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Early Palliative Care in Patients With Metastatic Upper Gastrointestinal Cancers Treated With First-line Chemotherapy

NCT02853474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2023-04-26

No results posted yet for this study

Summary

This prospective, randomized, open-label and multicenter phase III study is aimed to estimate the survival benefit of Early Palliative Care (EPC) combined with standard oncology care including first-line chemotherapy (experimental arm) over standard oncology care only (standard arm), in patients with metastatic upper gastrointestinal cancers (gastric cancer, pancreatic cancer, biliary tract cancers).

Conditions

Interventions

BEHAVIORAL

Early Palliative Care visit

A PC visit is a visit done by a PC physician. Any kind of visits done by other professionals IS NOT a PC visit. Five PC visits are scheduled in this arm.

OTHER

EORTC-QLQ-C30 questionnaire

The Quality of Life is assessed with the QLQ-C30 questionnaire at baseline, 12 and 24 weeks after inclusion, as well as every 8 weeks thereafter.

OTHER

HADS score

The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at baseline, and then 12 and 24 weeks after inclusion.

Sponsors & Collaborators

  • Ligue contre le cancer, France

    collaborator OTHER

  • Région Nord-Pas de Calais, France

    collaborator OTHER

  • National Cancer Institute, France

    collaborator OTHER_GOV

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Arlette Da Silva, MD · Centre Oscar Lambret

  • Antoine Adenis, MD, PhD · Centre Oscar Lambret

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT02853474 on ClinicalTrials.gov