AdenocarcinomaNCT01171300
Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
A study testing 18F- FDG PET scans and DW-MRI scans in people with Adenocarcinoma and Rectal Neoplasms, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma, Rectal Neoplasms
- What is being tested?
- 18F- FDG PET scans and DW-MRI scans
- How many people
- 94 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2010to Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- Patient is at least 18 years of age.
- Patient's body weight is ≤ 120 kg.
- Histologically proven and evaluable (according to RECIST criteria) adenocarcinoma of the rectum (tumour <15 cm from the anal verge), staged T3-4 N0 and T1-4N1-2.
- WHO PS ≤ 2
- Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
- Hemoglobin >10.0 g/dL,
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- Absolute neutrophil count > 1.5 x 109/L,
- Platelet count > 100 x 109/L,
- Presence of adequate contraception in fertile patients. Adequate methods of contraception are: intra-uterine device, hormonal contraception, condom use with spermicide.
- Written informed consent must be given according to ICH/GCP and national/local regulations.
Who cannot join
- Evidence of distant metastases.
- Prior chemotherapy or radiotherapy for rectal cancer.
- Pregnant or breastfeeding women.
- Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease).
- Known allergies to intravenous contrast agents.
- Contra-indications for magnetic resonance imaging (metal implants, claustrophobia, etc. ).
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- Previous or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and non-melanoma skin cancer.
- History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.
- Conditions
- Adenocarcinoma, Rectal Neoplasms
- Being tested
- 18F- FDG PET scans, DW-MRI scans
- Keywords
- staged T3-4 N0 and T1-4N1-2, adenocarcinoma of the rectum, rectum
- Medical subject headings
- Adenocarcinoma, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F- FDG PET scansOther
We aim to investigate the value of FGD-PET for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
DW-MRI scansOther
We aim to investigate the value of DW-MRI for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (ypT0N0) rate
Measured: 6-8 weeks after the end of chemoradiotherapy
Secondary outcomes (2)
Pathologic downstaging (ypT0-2N0) rate and Tumour Regression Grade (TRG); according to Dworak et al. Response rate at time of surgery (RECIST criteria based on MRI);
Measured: 6-8 weeks after the end of chemoradiotherapy
Quality of mesorectal excision.
Measured: 6-8 weeks after the end of chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2015
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Haustermans, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01171300
- Sponsor's protocol ID
- S52399
- Status last verified
- Jul 2024
- First submitted
- 13 Jul 2010
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Response Before, During and After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01171300
- Acronym / sponsor ID
- S52399
- Conditions
- Adenocarcinoma, Rectal Neoplasms
- Keywords
- staged T3-4 N0 and T1-4N1-2, adenocarcinoma of the rectum, rectum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Jul 2010 (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.
Rectal cancer is a frequent but curable malignancy in the Western world. The golden standard in treating these patients consists of neoadjuvant chemoradiotherapy (CRT) followed by extensive surgery regardless of tumor response. The main question is whether extensive surgery can be avoided holding in mind that already a significant amount of patients reach a pathological complete response after radiochemotherapy. The goal of this study is dual. First of all, the investigators want to investigate the value of DW-MRI and 18FDG-PET in the assessment of response after neoadjuvant CRT in 100 patients with rectal cancer, to select those patients eligible for less invasive surgery. In the same patient group, the investigators will examine the biomarker potential of molecular characteristics of the tumor in blood and tissue. Using both molecular and radiological findings, the investigators want to predict pathological response after chemoradiotherapy and to select patients who may benefit from treatment adjustments during chemoradiotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is at least 18 years of age.
- Patient's body weight is ≤ 120 kg.
- Histologically proven and evaluable (according to RECIST criteria) adenocarcinoma of the rectum (tumour <15 cm from the anal verge), staged T3-4 N0 and T1-4N1-2.
- WHO PS ≤ 2
- Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
Key exclusion criteria (9 listed)
- Evidence of distant metastases.
- Prior chemotherapy or radiotherapy for rectal cancer.
- Pregnant or breastfeeding women.
- Significant impairment of intestinal resorption (e.g. chronic diarrhea, inflammatory bowel disease).
- Known allergies to intravenous contrast agents.
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 |
|---|---|---|
| 18F- FDG PET scansWe aim to investigate the value of FGD-PET for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging)) | Other | – |
| DW-MRI scansWe aim to investigate the value of DW-MRI for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging)) | Other | – |
Primary outcome
Pathologic complete response (ypT0N0) rate
Time frame: 6-8 weeks after the end of chemoradiotherapy
2 secondary outcomes
Pathologic downstaging (ypT0-2N0) rate and Tumour Regression Grade (TRG); according to Dworak et al. Response rate at time of surgery (RECIST criteria based on MRI);
Time frame: 6-8 weeks after the end of chemoradiotherapy
Quality of mesorectal excision.
Time frame: 6-8 weeks after the end of chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Related InfoLink provided by the sponsor.
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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.
Karin Haustermans, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F- FDG PET scans and DW-MRI scans in people with Adenocarcinoma and Rectal Neoplasms, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
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?
Pathologic complete response (ypT0N0) rate (time frame: 6-8 weeks after the end of chemoradiotherapy). 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 10 Jul 2024.