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

Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Chemoradiation; Rectal Cancer; Radiation Therapy
• Intervention / Treatment: Other: EORTC QLQ C30; Other: EORTC QLQ CR29

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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Falk Roeder, MD; Phone Number: 73729 +49 89 4400; Email: Falk.Roeder@t-online.de
• Study Contact Backup: Name: Sabine Gerum, MD; Phone Number: 73770 +49 89 4400; Email: Sabine.Gerum@med.uni-muenchen.de

Study Locations

• Germany
  • Bavaria
    • Munich, Bavaria, Germany, 81377
      • Recruiting
      • Department of Radiation Oncology, University Hospital, LMU Munich
      • Sub-Investigator: Franziska Walter, MD
      • Sub-Investigator: Michael Hoffmann, MD
      • Contact: Falk Roeder, MD; Phone Number: +49 89 4400 73729; Email: Falk.Roeder@med.uni-muenchen.de
      • Contact: Sabine Gerum, MD; Phone Number: +49 89 4400 73729; Email: Sabine.Gerum@med.uni-muenchen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

see eligibility criteria

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: EORTC QLQ C30; standardized questionaire; Other: EORTC QLQ CR29; standardized 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	Other: EORTC QLQ C30; standardized questionaire; Other: EORTC QLQ CR29; standardized questionaire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ludwig-Maximilians - University of Munich
• Investigators: Principal Investigator: Falk Roeder, MD, Ludwig-Maximilians Universitat Munchen

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 6, 2018
• Last Update Submitted That Met QC Criteria: November 2, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: neoadjuvant; quality of life; rectal cancer; radiation therapy; chemoradiation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: V1 10.07.2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No