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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT03731130

Studienbeginn:
Oktober 2018

Letztes Update:
06.11.2018

Wirkstoff:
-

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Ludwig-Maximilians - University of Munich

Collaborator:
-

Studienleiter

Falk Roeder, MD
Principal Investigator
Ludwig-Maximilians Universität München

Kontakt

Falk Roeder, MD
Kontakt:
Phone: +49 89 4400
Phone (ext.): 73729
E-Mail: Falk.Roeder@t-online.de» Kontaktdaten anzeigen

Sabine Gerum, MD
Kontakt:
Phone: +49 89 4400
Phone (ext.): 73770
E-Mail: Sabine.Gerum@med.uni-muenchen.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Department of Radiation Oncology, University Hospital, LMU Munich
81377 Munich
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Falk Roeder, MD
Phone: +49 89 4400 73729
E-Mail: Falk.Roeder@med.uni-muenchen.de

Sabine Gerum, MD
Phone: +49 89 4400 73729
E-Mail: Sabine.Gerum@med.uni-muenchen.de» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. QoL (EORTC QLQC30) absolute values 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):
Quality of life measured by EORTC questionaires QLQC30 in absolute values at different time points and change over time

2. QoL (EORTC QLQCR29) absolute values 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):
Quality of life measured by EORTC questionaires QLQCR29 in absolute values at different time points and change over time

Secondary outcome:

1. acute toxicity (Time Frame - 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

2. late toxicity (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):
late toxicity according to CTCAE 4.03

3. local control (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):
Absence of local regrowth

4. distant control (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):
Absence of distant metastases

5. freedom from Treatment failure (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):
Absence of local or distant relapse

6. Overall survival (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):
Absence of death from any cause

Studien-Arme

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.
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

Geprüfte Regime

EORTC QLQ C30:
standardized questionaire
EORTC QLQ CR29:
standardized questionaire

Quelle: ClinicalTrials.gov

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