NCT03712774

Brief Summary

Prospective observational study to evaluate the Quality of life based on standardized EORTC questionaires as well as toxicities, functional and oncological outcomes in patients treated with neoadjuvant or definitive chemoradiation for esophageal Cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
8mo left

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Oct 2018Dec 2026

Study Start

First participant enrolled

October 12, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

October 19, 2018

Status Verified

October 1, 2018

Enrollment Period

3.2 years

First QC Date

October 17, 2018

Last Update Submit

October 18, 2018

Conditions

Quality of LifeChemoradiationEsophageal Cancer

Keywords

quality of lifeneoadjuvantdefinitivechemoradiationesophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Quality of life measured by standardized EORTC questionaires

    planning CT (day 0), week 4 of RT, 6 weeks after end of RT, 3 months after end of RT, 6 months after end of RT, 12 months after end of RT, 24, 36, 48, and 60 months after end of RT

Secondary Outcomes (6)

  • Local control

    3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

  • Distant Control

    3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

  • freedom from treatment failure

    3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

  • Overall survival

    3 months after end of RT, 6 months after end of RT, 9 months after end of RT, 12 months after end of RT, 24,36,48,60 months after end of RT

  • acute toxicity

    end of RT, 6 weeks after end of RT, 3 months after end of RT

  • +1 more secondary outcomes

Study Arms (2)

neoadjuvant chemoradiation

Patient with esophageal Cancer treated by neoadjuvant chemoradiation followed by surgery will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

Other: EORTC QLQ C30Other: EORTC QLQ OES-18Other: EORTC OG-25

definitive chemoradiation

Patient with esophageal Cancer treated by definitive chemoradiation will be longitudinally evaluated by questionaires EORTC QLQ C30, EORTC QLQ OES-18 and EORTC OG-25

Other: EORTC QLQ C30Other: EORTC QLQ OES-18Other: EORTC OG-25

Interventions

EORTC QLQ C30OTHER

standardized questionaire

definitive chemoradiationneoadjuvant chemoradiation
EORTC QLQ OES-18OTHER

standardized questionaire

definitive chemoradiationneoadjuvant chemoradiation
EORTC OG-25OTHER

standardized questionaire

definitive chemoradiationneoadjuvant chemoradiation

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

see eligibility criteria

You may qualify if:

  • histologically proven esophageal Cancer (SCC or adenocarcinoma) without distant metastases (except supraclavicular nodes)
  • indication for neoadjuvant or definitive chemoradiation using either cisplatin/5-FU or carboplatin/paclitaxel with curative intent
  • age \>= 18 years
  • written informed consent
  • ability to answer the standardized questionaires according to the treating physician

You may not qualify if:

  • age \< 18 years
  • Treatment with palliative intent
  • distant metastases (except supraclavicular nodes)
  • second malignancy
  • Prior systemic treatment for esophageal Cancer
  • Treatment in an interventional study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, University Hospital, LMU Munich

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Falk Roeder, MD

    Ludwig-Maximilians Universität München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Falk Roeder, MD

CONTACT

+49 89 4400Falk.Roeder@t-online.de

Franziska Walter, MD

CONTACT

+49 89 4400Franziska.Walter@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 19, 2018

Study Start

October 12, 2018

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

October 19, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)