Rectal CancerThunderNCT00969657
Validation of a Predictive Model After Complete Response in Rectal Cancer
An observational study of Rectal Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Background of the study: Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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: primary care clinic
Who may be able to join
- Histological proven rectal cancer
- UICC stage I-III
- Only primary tumors; no recurrences
- Only concurrent chemoradiotherapy treatment
- Willing and able to comply with the study prescriptions
- 18 years or older
- Have given written informed consent before patient registration
- No previous radiotherapy to the pelvis
Who cannot join
- No adenocarcinoma histology
- History of prior pelvis radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Validation of a Predictive Model for Pathologic Complete Response After Chemoradiotherapy in Rectal Cancer: A Prognostic Study
Background of the study:
Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-[18F] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models.
Read more
Objective of the study:
The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.
Study design:
28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.
Read the detailed description
General objective
The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.
Aim of the study
The main aim is to validate a predictive model for pathologic complete response (ypT0N0) in rectal cancer patients treated with chemoradiotherapy by multi-centric prospective data collection. The second aim is to collect extra data for improvement of the accuracy of the prediction models with new variables. This new model will be validated later in the model development process.
Hypothesis
General hypothesis:
The validated accuracy of predictive models for pathologic complete response after chemoradiotherapy in rectal cancer patients is high enough to tailor treatment (surgery/non-surgery and/or administer extra radiation boosts) in clinical practice.
Specific hypotheses:
- The performance of the developed models on the validation data is at least equal to the performance achieved during the model development process.
- The performance of a new model based on the addition of variables performs better than the previous model
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer stage I-III, concurrent chemoradiotherapie, response prediction
- Medical subject headings
- Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (ypT0N0)
Measured: 8-12 weeks after long-series chemoradiotherapy
Secondary outcomes (1)
Several extra outcomes are registered for research: Local relapse at 2 years, metastases free survival, survival and relapse free survival
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2011
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Lambin, prof, Study director, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969657
- Sponsor's protocol ID
- 6050
- Other IDs
- 09-03-023
- Acronym
- Thunder
- Status last verified
- Jan 2015
- First submitted
- 31 Aug 2009
- Last updated
- 13 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Roelofs E, Dekker A, Meldolesi E, van Stiphout RGPM, Valentini V, Lambin P. International data-sharing for radiotherapy research: an open-source based infrastructure for multicentric clinical data mining. Radiother Oncol. 2014 Feb;110(2):370-374. doi: 10.1016/j.radonc.2013.11.001. Epub 2013 Dec 3.
PubMed 24309199
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Predictive Model for Pathologic Complete Response After Chemoradiotherapy in Rectal Cancer: A Prognostic Study
- ClinicalTrials.gov ID
- NCT00969657
- Acronym / sponsor ID
- Thunder / 6050
- Conditions
- Rectal Cancer
- Keywords
- rectal cancer stage I-III, concurrent chemoradiotherapie, response prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Sep 2009 (estimated)
- 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.
Background of the study:
Prediction of rectal tumor response after chemoradiotherapy (CRT) might be helpful in individualizing treatment strategies, i.e., selecting patients who need less invasive surgery or another radiotherapy strategy instead of resection. For rectal cancer it is known that 10-30% of the patients will respond with a pathologic complete response (pCR) after CRT. From a retrospective study with multivariate analysis of both clinical and 2-[18F] fluoro-2-deoxy-D-glucose and positron emission tomography (FDG-PET) data, it was found that adding FDG-PET data collected before and after CRT leads to a more predictive model compared to evaluating only pretreatment clinical data. To validate this model, this registration study is proposed. Furthermore, it has been found that FDG-PET during treatment is very predictive for response and a more favorable time point to adapt treatment. Also, there are indications that adding blood biomarkers to the data, results in higher accuracy for response prediction compared to clinical and imaging data alone. Therefore, FDG-PET during treatment and blood sampling are included in the protocol to improve the accuracy of the prediction models.
Objective of the study:
The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.
Study design:
28x radiotherapy. On day 15 of radiotherapy en 8 weeks after radiotherapy: 1 PET-CT scan Before radiotherapy, on day 15 and 8 weeks after radiotherapy: blood sample taken.
Detailed description
General objective
The long-term research objective is to be able to select rectum cancer patients who could receive a less invasive treatment. If prediction of response is possible, surgery may be avoided when complete response after chemoradiotherapy is expected or performed with smaller incisions if stage reduction is significant. This support decision system helps to individualize patient treatment and can improve the quality of life for the patient.
Aim of the study
The main aim is to validate a predictive model for pathologic complete response (ypT0N0) in rectal cancer patients treated with chemoradiotherapy by multi-centric prospective data collection. The second aim is to collect extra data for improvement of the accuracy of the prediction models with new variables. This new model will be validated later in the model development process.
Hypothesis
General hypothesis:
The validated accuracy of predictive models for pathologic complete response after chemoradiotherapy in rectal cancer patients is high enough to tailor treatment (surgery/non-surgery and/or administer extra radiation boosts) in clinical practice.
Specific hypotheses:
- The performance of the developed models on the validation data is at least equal to the performance achieved during the model development process.
- The performance of a new model based on the addition of variables performs better than the previous model
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (8 listed)
- Histological proven rectal cancer
- UICC stage I-III
- Only primary tumors; no recurrences
- Only concurrent chemoradiotherapy treatment
- Willing and able to comply with the study prescriptions
Key exclusion criteria (2 listed)
- No adenocarcinoma histology
- History of prior pelvis radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pathological complete response (ypT0N0)
Time frame: 8-12 weeks after long-series chemoradiotherapy
1 secondary outcome
Several extra outcomes are registered for research: Local relapse at 2 years, metastases free survival, survival and relapse free survival
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2015.
- Derived from this study: PubMed 24309199Roelofs E, Dekker A, Meldolesi E, van Stiphout RGPM, Valentini V, Lambin P. International data-sharing for radiotherapy research: an open-source based infrastructure for multicentric clinical data mining. Radiother Oncol. 2014 Feb;110(2):370-374. doi: 10.1016/j.radonc.2013.11.001. Epub 2013 Dec 3.
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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. This study is not recruiting at the moment.
Philippe Lambin, prof study director
Maastricht Radiation Oncology
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 Rectal Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jan 2015. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (ypT0N0) (time frame: 8-12 weeks after long-series chemoradiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00969657, which also lists 1 linked publication.
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 13 Jan 2015.