Clinical trial NCT03731130: Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
Official title: Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Quality of Life
Radiation Therapy
Chemoradiation
Keywords: rectal cancer
quality of life
neoadjuvant
radiation therapy
chemoradiation
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: see eligibility criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: QoL (EORTC QLQC30) absolute values and change over time
timeFrame: 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
measure: QoL (EORTC QLQCR29) absolute values and change over time
timeFrame: 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:
measure: acute toxicity
timeFrame: short-term radiation: day 0, end of week 1, long-term chemoradiation: day 0, end of week 6, 14
measure: late toxicity
timeFrame: 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
measure: local control
timeFrame: 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
measure: distant control
timeFrame: 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
measure: freedom from Treatment failure
timeFrame: 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
measure: Overall survival
timeFrame: 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
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Radiation Oncology, University Hospital, LMU Munich
state: Bavaria
Study officials:
affiliation: Ludwig-Maximilians Universität München
name: Falk Roeder, MD
role: PRINCIPAL_INVESTIGATOR
References: