Rectal CancerNEOCARENCT03731130
Prospective Observational Trial to Evaluate Quality of Life After Neoadjuvant Radiation or Chemoradiation Followed by Surgery in Patients With Rectal Cancer
An observational study of Rectal Cancer and Quality of Life, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Quality of Life, Radiation Therapy
- What is being tested?
- EORTC QLQ C30 and EORTC QLQ CR29
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 5 Oct 2018to 31 Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: see eligibility criteria
Who may be able to join
- 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
Who cannot join
- age < 18 years
- prior systemic therapy with regard to rectal Cancer
- distant metastasis
- second malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, University Hospital, LMU Munich
Munich, Bavaria, 81377
Falk Roeder, MD, +49 89 4400 73729, Falk.Roeder@med.uni-muenchen.de
Sabine Gerum, MD, +49 89 4400 73729, Sabine.Gerum@med.uni-muenchen.de
About this study
Official title: 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
Read the 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.
- Conditions
- Rectal Cancer, Quality of Life, Radiation Therapy, Chemoradiation
- Being tested
- EORTC QLQ C30, EORTC QLQ CR29
- Keywords
- rectal cancer, quality of life, neoadjuvant, radiation therapy, chemoradiation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EORTC QLQ C30Other
standardized questionaire
EORTC QLQ CR29Other
standardized questionaire
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: EORTC QLQ C30; Other: EORTC QLQ CR29 | |
| 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 Receives: Other: EORTC QLQ C30; Other: EORTC QLQ CR29 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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 (6)
acute toxicity
acute toxicity by Radiation or chemoradiation according to CTCAE 4.03
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start5 Oct 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Falk Roeder, Ludwig-Maximilians - University of Munich
- Investigators
- Falk Roeder, MD, Principal investigator, Ludwig-Maximilians Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731130
- Sponsor's protocol ID
- V1 10.07.2018
- Acronym
- NEOCARE
- Status last verified
- Nov 2018
- First submitted
- 17 Oct 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No