NCT03731130

Brief Summary

Observational study to evaluate longitudinal quality of life according to standardized EORTC questionaires as well as functional Outcome, oncological outcome and toxicity in patients treated with neoadjuvant short term radiation or long-term chemoradiation followed by surgery

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 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 5, 2018

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 6, 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

November 6, 2018

Status Verified

November 1, 2018

Enrollment Period

3.2 years

First QC Date

October 17, 2018

Last Update Submit

November 2, 2018

Conditions

Rectal CancerQuality of LifeRadiation TherapyChemoradiation

Keywords

rectal cancerquality of lifeneoadjuvantradiation therapychemoradiation

Outcome Measures

Primary Outcomes (2)

  • QoL (EORTC QLQC30) absolute values and change over time

    Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time

    short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274

  • QoL (EORTC QLQCR29) absolute values and change over time

    Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time

    short-term radiation: day 0, end of week 1, week 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274

Secondary Outcomes (6)

  • acute toxicity

    short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14

  • late toxicity

    short-term radiation: end of week 27, 53, 105, 157, 209, 261, long-term chemoradiation: end of week 27, 40, 66, 118, 170, 222, 274

  • local control

    short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274

  • distant control

    short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274

  • freedom from Treatment failure

    short-term radiation: day 0, end of week 1, 14, 27, 53, 105, 157, 209, 261, long-term chemoradiation: day 0, end of week 6, 14, 27, 40, 66, 118, 170, 222, 274

  • +1 more secondary outcomes

Study Arms (2)

neoadjuvant short term radiation

Treatment with neoadjuvant short term radiation therapy (5x5 Gy) followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire.

Other: EORTC QLQ C30Other: EORTC QLQ CR29

neoadjuvant long-term chemoradiation

Treatment with neoadjuvant Long-term chemoradiation followed by surgery. Quality of life will be assessed using the EORTC QLQ C30 and EORTC QLQ CR 29 questionaire

Other: EORTC QLQ C30Other: EORTC QLQ CR29

Interventions

EORTC QLQ C30OTHER

standardized questionaire

neoadjuvant long-term chemoradiationneoadjuvant short term radiation
EORTC QLQ CR29OTHER

standardized questionaire

neoadjuvant long-term chemoradiationneoadjuvant short term radiation

Eligibility Criteria

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

see eligibility criteria

You may qualify if:

  • histologically proven rectal Cancer without distant metastases
  • indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary Evaluation
  • 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
  • prior systemic therapy with regard to rectal Cancer
  • distant metastasis
  • second malignancy

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

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal 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

Sabine Gerum, MD

CONTACT

+49 89 4400Sabine.Gerum@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

November 6, 2018

Study Start

October 5, 2018

Primary Completion

December 31, 2021

Study Completion (Estimated)

December 31, 2026

Last Updated

November 6, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)