Locally Advanced Rectum CancerFAZANCT01257035
Predictive Value of 18F-FAZA in Rectum Cancer
An observational study of Locally Advanced Rectum Cancer, run by Vejle Hospital at 1 site in Denmark.
Trial summary
The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectum Cancer
- What is being tested?
- 18F-FAZA-PET/CT
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2010to Aug 2012
- 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: Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.
Who may be able to join
- Histopatologically verified adenocarcinoma in the rectum
- T4 tumor eller T3 tumor < 10 cm from the anus and < 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is < 5 mm and therefore all T3 tumors are included in this area
- Suitable for preoperative radiation and chemotherapy
- No distant metastases
- Age >18 years
- Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
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- Biochemistry Bilirubin ≤ 3 x UNL. ALAT ≤ 5 x UNL
- Creatinine ≤ UNL
- Contraception for fertile women
- Written and orally informed consent
Who cannot join
- Other malignant disease within 5 years, excl. non-melanotic skin cancer
- Previous radiation treatment of the pelvis
- Pregnant or breastfeeding women
- Surgery within 6 weeks prior to enrollment
- Serious concurrent medical disease
- Enrollment in study "A prospective observational study of patients with rectum cancer after concomitant radiation and chemotherapy", where the patients are potientially not operated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer
The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.
- Conditions
- Locally Advanced Rectum Cancer
- Being tested
- 18F-FAZA-PET/CT
- Keywords
- Rectum cancer, FAZA, 18F-FAZA-PET/CT, Radiotherapy, Chemoradiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAZA-PET/CTOther
Contrast fluid injected prior to scan
| Study group | Role | What they receive |
|---|---|---|
| 18F-FAZA-PET/CT | Not described Receives: Other: 18F-FAZA-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to chemoradiotherapy measured by TRG
Measured: 8 weeks after chemoradiation treatment
Secondary outcomes (2)
Recurrence free survival
Measured: From date of inclusion till date of verified recurrence
Survival
Measured: From date of inclusion till date of death by any cause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionFeb 2012
- Study completionAug 2012
Why it stopped: The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectum 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257035
- Sponsor's protocol ID
- S-20100054
- Acronym
- FAZA
- Status last verified
- Jun 2013
- First submitted
- 8 Dec 2010
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of 18F-FAZA-PET/CT in Neoadjuvant Radiation for Patients With Locally Advanced Rectum Cancer
- ClinicalTrials.gov ID
- NCT01257035
- Acronym / sponsor ID
- FAZA / S-20100054
- Conditions
- Locally Advanced Rectum Cancer
- Keywords
- Rectum cancer, FAZA, 18F-FAZA-PET/CT, Radiotherapy, Chemoradiotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- Nov 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Dec 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.
The primary purpose of the study is to investigate 18F-FAZA-PETs role as predictor of response to neoadjuvant chemoradiation of locally advanced rectum cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FAZA-PET/CT | – | Other: 18F-FAZA-PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with locally advanced rectum cancer receiving preoperative radiation treatment and concomitant chemotherapy at the Dept. of Oncology, Vejle Hospital.
Key inclusion criteria (10 listed)
- Histopatologically verified adenocarcinoma in the rectum
- T4 tumor eller T3 tumor < 10 cm from the anus and < 5 mm from the mesorectal fascie measured by MR scan. At the distal part of the rectum the distance to the mesorectal fascie is < 5 mm and therefore all T3 tumors are included in this area
- Suitable for preoperative radiation and chemotherapy
- No distant metastases
- Age >18 years
Key exclusion criteria (6 listed)
- Other malignant disease within 5 years, excl. non-melanotic skin cancer
- Previous radiation treatment of the pelvis
- Pregnant or breastfeeding women
- Surgery within 6 weeks prior to enrollment
- Serious concurrent medical disease
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-FAZA-PET/CTContrast fluid injected prior to scan | Other | 18F-FAZA-PET/CT |
Primary outcome
Response to chemoradiotherapy measured by TRG
Time frame: 8 weeks after chemoradiation treatment
2 secondary outcomes
Recurrence free survival
Time frame: From date of inclusion till date of verified recurrence
Survival
Time frame: From date of inclusion till date of death by any cause
Results and safety
The study was stopped early (reason given: The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Locally Advanced Rectum Cancer, run by Vejle Hospital at 1 site in Denmark.
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 6 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: stopped early, as of the sponsor's last update on 17 Jun 2013. 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 Denmark. 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 was stopped early (reason given: The logistics of this trial (incl. supply of tracer) in connection with the patients' treatment course caused the inclusion rate to be very slow.). 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?
Response to chemoradiotherapy measured by TRG (time frame: 8 weeks after chemoradiation treatment). 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 17 Jun 2013.