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NCT Number: NCT03731130

Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant 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

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Key information

Conditions

Rectal Cancer Chemoradiation Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Quality of Life Radiation Therapy Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EORTC QLQ C30

Other

standardized questionaire

EORTC QLQ CR29

Other

standardized questionaire

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Falk Roeder, MD

CONTACT

[email protected]

+49 89 4400 ext. 73729

Sabine Gerum, MD

CONTACT

[email protected]

+49 89 4400 ext. 73770

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer

Acronym: NEOCARE

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Nov 6, 2018
Registry last updated
Nov 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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