Rectal AdenocarcinomaPhase 2NCT01619696
Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas
A Phase 2 study testing Pelvic MRI and F MISO TEP in people with Rectal Adenocarcinoma, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Pelvic MRI and F MISO TEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Dec 2012
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.
Who cannot join
- synchonous metastatis
- previous malignant tumour
- previous radiotherapy/ chemotherapy
- performance status WHO>2
- contraindication to 5 FU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
Read the detailed description
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.
Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Pelvic MRI and F MISO TEP
- Keywords
- chemotherapy, rectal adenocarcinoma, proctectomy, Fmiso TEP, MRI
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic MRI and F MISO TEPProcedure or surgery
Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Procedure: Pelvic MRI and F MISO TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptation rate of the entire sequence by eligible patients
acceptation rate of the entire sequence by eligible patients
Measured: 13 weeks
Secondary outcomes (1)
radiological changes while on chimiotherapy, to tumour regression, and prognosis
radiological changes while on chimiotherapy, to tumour regression, and prognosis
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2012 (estimated)
- Study startMar 2011
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Guillaume Portier, PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01619696
- Sponsor's protocol ID
- 0932103
- Status last verified
- Jan 2013
- First submitted
- 12 Jun 2012
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Pilot Study of Multimodal Radiological Evaluation Feasibility During Chemoradiotherapy of Rectal Adenocarcinomas.
- ClinicalTrials.gov ID
- NCT01619696
- Acronym / sponsor ID
- 0932103
- Conditions
- Rectal Adenocarcinoma
- Keywords
- chemotherapy, rectal adenocarcinoma, proctectomy, Fmiso TEP, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Centre National de la Recherche Scientifique, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Mar 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 14 Jun 2012 (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 objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
Detailed description
The objective of the present project is to validate the feasibility of a multimodal radiological pathway while on chemoradiotherapy, in order to validate potentially predictive factors for chemoradiotherapy sensitivity of rectal adenocarcinomas.
It is based on a structured clinical and radiological pathway for patients, using diffusion MRI and F misonidazole PET.
Validation of these new tools is already needed in clinical practice since future institutional trials will be based on treatment individualisation, using preoperative predicting factors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Pelvic MRI and F MISO TEP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- locally advanced (≥T3) resectable rectal adenocarcinoma between 2 and 10 cm from the anal verge.
Key exclusion criteria (5 listed)
- synchonous metastatis
- previous malignant tumour
- previous radiotherapy/ chemotherapy
- performance status WHO>2
- contraindication to 5 FU
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 |
|---|---|---|
| Pelvic MRI and F MISO TEPPelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy. | Procedure or surgery | Intervention |
Primary outcome
acceptation rate of the entire sequence by eligible patients
Time frame: 13 weeks
acceptation rate of the entire sequence by eligible patients
1 secondary outcome
radiological changes while on chimiotherapy, to tumour regression, and prognosis
Time frame: 13 weeks
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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.
Guillaume Portier, PhD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pelvic MRI and F MISO TEP in people with Rectal Adenocarcinoma, run by University Hospital, Toulouse at 1 site in France.
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 1 inclusion and 5 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 23 Jan 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 France. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Insufficient recruitment). 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?
acceptation rate of the entire sequence by eligible patients (time frame: 13 weeks). 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 23 Jan 2013.