Anal CancerLANACARENCT03792854
Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
An observational study of Anal 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 definitive chemoradiation for anal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Cancer, Quality of Life, Chemoradiation
- What is being tested?
- EORTC QLQ C30 and EORTC QLQ CR29
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2018to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 anal cancer without distant metastases
- indication for definitive chemoradiation therapy based on multidisciplinary 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 anal cancer
- distant metastases
- 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, +49894400 ext. 73729, Falk.Roeder@med.uni-muenchen.de
Sabine Gerum, MD, +49894400 ext. 73729, sabine.gerum@med.uni-muenchen.de
About this study
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 definitive chemoradiation for anal cancer
Read the detailed description
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 definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ 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 patients-assessed functional outcomes are planned.
- Conditions
- Anal Cancer, Quality of Life, Chemoradiation
- Being tested
- EORTC QLQ C30, EORTC QLQ CR29
- Keywords
- anal cancer, quality of life, chemoradiation
- Medical subject headings
- Anus 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
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 questionaire QLQC30 in absolute values at different time points and change over time
Measured: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Qol (EORTC QLQCR29) absolute values and change over time
Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time
Measured: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Secondary outcomes (6)
local control
absence of disease progression inside the target volume of radiation therapy
Measured: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
distant control
absence of disease progression outside the target volume of radiation therapy
Measured: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
freedom from treatment failure
absence of disease progression inside or outside the target volume of radiation therapy
Measured: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
overall survival
absence of death from any cause
Measured: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
acute toxicity
acute toxicity caused by chemoradiation according to CTCAE 4.03
Measured: day 0, end of week 6, 12, 19
late toxicity
late toxicity caused by chemoradiation according to CTCAE 4.03
Measured: end of week 32, 58, 84, 110, 162, 214, 266
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2019
- Study start1 Dec 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal 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
- NCT03792854
- Sponsor's protocol ID
- V1 10/2018
- Acronym
- LANACARE
- Status last verified
- Jan 2019
- First submitted
- 2 Jan 2019
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial to Evaluate Quality of Life After Definitive Chemoradiation in Patients With Anal Cancer (LANACARE)
- ClinicalTrials.gov ID
- NCT03792854
- Acronym / sponsor ID
- LANACARE / V1 10/2018
- Conditions
- Anal Cancer, Quality of Life, Chemoradiation
- Keywords
- anal cancer, quality of life, chemoradiation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 definitive chemoradiation for anal cancer
Detailed description
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 definitive chemoradiation for anal cancer. Qol will be evaluated by standardized EORTC questionaires QLQ C30 and QLQ 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 patients-assessed functional outcomes are planned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- see eligibility criteria
Key inclusion criteria (5 listed)
- histologically proven anal cancer without distant metastases
- indication for definitive chemoradiation therapy based on multidisciplinary evaluation
- age >=18 years
- written informed consent
- ability to answer the standardized questionaires according to the treating physician
Key exclusion criteria (4 listed)
- age < 18 years
- prior systemic therapy with regard to anal cancer
- distant metastases
- second malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EORTC QLQ C30standardized questionaire | Other | – |
| EORTC QLQ CR29standardized questionaire | Other | – |
Primary outcome
Qol (EORTC QLQC30) absolute values and change over time
Time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Quality of life measured by EORTC questionaire QLQC30 in absolute values at different time points and change over time
Qol (EORTC QLQCR29) absolute values and change over time
Time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
Quality of life measured by EORTC questionaire QLQCR29 in absolute values at different time points and change over time
6 secondary outcomes
local control
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
distant control
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
freedom from treatment failure
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
overall survival
Time frame: end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266
acute toxicity
Time frame: day 0, end of week 6, 12, 19
late toxicity
Time frame: end of week 32, 58, 84, 110, 162, 214, 266
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Falk Roeder, MD principal investigator
Ludwig-Maximilians Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer and Quality of Life, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Falk Roeder, MD (+49894400 ext. 73729, falk.roeder@t-online.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qol (EORTC QLQC30) absolute values and change over time (time frame: day 0, end of week 6, 12, 19, 32, 58, 84, 110, 162, 214, 266). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019; AzTrials last refreshed its copy on 26 Oct 2026.