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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-05

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Observational study to evaluate longitudinal quality of life in patients treated with neoadjuvant short-course Irradiation or neoadjuvant Long-Course chemoradiation followed by surgery. QoL will be evaluated by standardized EORTC questionaires QLQ C30 and CR29. Acute and late toxicity will be assessed according to CTCAE 4.03. Oncological Outcome will be assessed with regard to local and distant Control, Patterns of recurrence, freedom from Treatment failure and Overall survival. Correlations of physicians- and Patient-assessed functional outcomes are planned.

Conditions

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Rectal Cancer Quality of Life Radiation Therapy Chemoradiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

EORTC QLQ C30

Intervention Type OTHER

standardized questionaire

EORTC QLQ CR29

Intervention Type OTHER

standardized questionaire

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

EORTC QLQ C30

Intervention Type OTHER

standardized questionaire

EORTC QLQ CR29

Intervention Type OTHER

standardized questionaire

Interventions

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EORTC QLQ C30

standardized questionaire

Intervention Type OTHER

EORTC QLQ CR29

standardized questionaire

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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