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

Ludwig-Maximilians - University of Munich100 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Rectal Cancer Quality of Life Radiation Therapy Chemoradiation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

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

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

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

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

freedom from Treatment failure

Absence of local or distant relapse

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

Overall survival

Absence of death from any cause

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts