NCT05194371

Brief Summary

In this study, data of esophageal cancer patients undergoing definitive radiotherapy in 14 institutions from various provinces in China were evaluated to help strengthen confidence in anti-cancer, including rehabilitation, economic burden, and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 24, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

December 24, 2021

Last Update Submit

January 14, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    5 year

Secondary Outcomes (3)

  • the European Organisation for Research and Treatment of Cancer (EORTC) questionnaire module to assess quality of life (QOL)

    5 year

  • Costs of treatment

    5 year

  • Proportion of using chemotherapy or target therapy concurrently with radiotherapy

    2 month

Study Arms (1)

Definitive (chemo)radiotherapy

Radiation: definitive radiotherapy or definitive chemoradiotherapy

Interventions

A total dose of radiation therapy should be more than 50Gy

Definitive (chemo)radiotherapy

Eligibility Criteria

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

Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016 in 14 institutions in China

You may qualify if:

  • Patients with esophageal cancer who received definitive radiotherapy (radiotherapy dose ≥50Gy) from 2015 to 2016
  • Age ≥ 18
  • The radiation field included primary esophageal tumor with or without lymph node metastasis

You may not qualify if:

  • Radiotherapy dose \< 50Gy
  • Palliative radiotherapy
  • The radiation field are metastatic areas, such as bone, brain, adrenal gland, isolated metastatic lymph nodes, etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Beijing, 100021, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lvhua Wang

    National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medic

    PRINCIPAL INVESTIGATOR
  • Kuaile Zhao

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 24, 2021

First Posted

January 18, 2022

Study Start

June 1, 2021

Primary Completion

October 31, 2021

Study Completion

December 15, 2021

Last Updated

January 18, 2022

Record last verified: 2022-01

Locations