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

Quality of Life Clinical Trial

— NEOCARE  

Official title:

Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03731130
• Other study ID #: V1 10.07.2018
• Status: Recruiting
• Start date: October 5, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2018
• Source: Ludwig-Maximilians - University of Munich
• Contact: Falk Roeder, MD
• Phone: +49 89 4400
• Email: Falk.Roeder[@]t-online.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemoradiation
• Quality of Life
• Radiation Therapy
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• EORTC QLQ C30
standardized questionaire
• EORTC QLQ CR29
standardized questionaire

Locations

Country	Name	City	State
Germany	Department of Radiation Oncology, University Hospital, LMU Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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