Health TrialsbyHealthPanel

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

ConditionsRectal CancerQuality of LifeRadiation TherapyChemoradiation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLudwig-Maximilians - University of Munich

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically proven rectal Cancer without distant metastases

indication for neoadjuvant Radiation or chemoradiation therapy according to multidiciplinary Evaluation

age >=18 years

written informed consent

Disqualifiers

age < 18 years

prior systemic therapy with regard to rectal Cancer

distant metastasis

second malignancy

Trial population

see eligibility criteria

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • EORTC QLQ C30

    Other intervention

    standardized questionaire

  • EORTC QLQ CR29

    Other intervention

    standardized questionaire

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: neoadjuvant short term radiation2 interventions
Group B: neoadjuvant long-term chemoradiation2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
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
2

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

Time frame
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

1

acute toxicity

acute toxicity by Radiation or chemoradiation according to CTCAE 4.03

Time frame
short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14
2

late toxicity

late toxicity according to CTCAE 4.03

Time frame
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
3

local control

Absence of local regrowth

Time frame
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
4

distant control

Absence of distant metastases

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig-Maximilians - University of Munich

Lead sponsor

Source ClinicalTrials.gov
Apply now