Chemoradiation, Quality of Life, Radiation Therapy, Rectal Cancer
Conditions
Keywords
rectal cancer, quality of life, neoadjuvant, radiation therapy, chemoradiation
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
Detailed description
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.
Interventions
OTHEREORTC QLQ C30
standardized questionaire
OTHEREORTC QLQ CR29
standardized questionaire
Sponsors
Ludwig-Maximilians - University of Munich
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QoL (EORTC QLQC30) absolute values 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 | Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time |
| QoL (EORTC QLQCR29) absolute values 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 | Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Absence of local regrowth |
| 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 | Absence of distant metastases |
| acute toxicity | short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14 | acute toxicity by Radiation or chemoradiation according to CTCAE 4.03 |
| Overall survival | 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 | Absence of death from any cause |
| 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 | Absence of local or distant relapse |
| 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 | late toxicity according to CTCAE 4.03 |
Countries
Germany
Contacts
Primary ContactFalk Roeder, MD
Backup ContactSabine Gerum, MD
Outcome results
None listed