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

Study Overview
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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

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.

Official Title
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Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Conditions
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Rectal Cancer, Quality of Life, Radiation Therapy, Chemoradiation

Intervention / Treatment
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* Other: EORTC QLQ C30
* Other: EORTC QLQ CR29


Participation Criteria
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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 Exclusion Criteria: age < 18 years prior systemic therapy with regard to rectal Cancer distant metastasis second malignancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| neoadjuvant short term radiation<br>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 C30<br>* standardized questionaire<br>Other: EORTC QLQ CR29<br>* standardized questionaire<br>|
| neoadjuvant long-term chemoradiation<br>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 C30<br>* standardized questionaire<br>Other: EORTC QLQ CR29<br>* standardized questionaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute toxicity | acute toxicity by Radiation or chemoradiation according to CTCAE 4.03 | short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14 | 
| late toxicity | late toxicity according to CTCAE 4.03 | 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 | Absence of local regrowth | 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 | Absence of distant metastases | 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 | Absence of local or distant relapse | 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 | 
| Overall survival | Absence of death from any cause | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectal cancer, quality of life, neoadjuvant, radiation therapy, chemoradiation