Rectum CancerPhase 1/2NCT00409994
Safety Study of Rapamycin Administered Before and During Radiotherapy to Treat Rectum Cancer
A Phase 1/2 study testing Rapamycin in people with Rectum Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- Rapamycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2006to Dec 2018
- Phase
- Phase 1/2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically proven rectum cancer
- UICC TNM I-III
- WHO performance status 0-2
- Less than 10% weight loss the last 6 months
- No recent (< 3 months) severe cardiac disease
- Normal serum bilirubin and serum creatinin
Who cannot join
- Concurrent chemotherapy with radiation
- History of prior pelvis radiotherapy
- Recent (<3 months) myocardial infarction
- Uncontrolled infectious disease
- Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht Radiation Oncology
Maastricht, Limburg, 6202 AZ
About this study
Official title: A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and Phase II Study
Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.
Read the detailed description
Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days. At step 1 a dose of 2 mg will be given once a day; at step 2 a dose of 4 mg will be given once a day; at step 3 a dose of 6 mg will be given once a day.
Preoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by TME-surgery at day 15.
Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days (unless the optimal dose found in the phase I study is lower).
Preoperative radiotherapy (5x 5 Gy) will be administered at day 9-15, followed by TME-surgery 7-8 weeks post RT.
Sample size Phase I dose-escalation study Minimum 3 eligible patients per step, maximum 6 eligible patients per step. Phase II A total of 47 patients will be entered in this part of the study.
- Conditions
- Rectum Cancer
- Being tested
- Rapamycin
- Keywords
- Colorectal cancer, M-tor inhibitor, Rapamycin
- Medical subject headings
- Rectal Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus
dosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days
| Study group | Role | What they receive |
|---|---|---|
| Rapamycine | Experimental | rapamycine 6 mg dd Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence of severe postoperative complications (grade IV or grade V),
Measured: within the first 6 weeks after surgery
assessed according to CTCv3.0
Measured: within the first 6 weeks after surgery
Phase II: Tumour blood flow assessed CT-PET + CTp
Measured: day 64
Secondary outcomes (4)
Phase I:Incidence of other acute toxicity, assessed according to CTCv 3.0
Measured: within the first 6 weeks after surgery
Activation status of mTor related and dependent molecules in the tumour
Measured: within the first 6 weeks after surgery
Phase II:Maximum standardised Uptake Value (SUV) of 18F-FDG, assessed bij PET-CT-scan
Measured: day 64
Phase II:Incidence of acute side effects of rapamycin, assessed according to CTCv 4.0
Measured: day 8, 15, 22, 36, 50 and 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startSep 2006
- Primary completion3 Aug 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Ziekenhuis Maastricht
- Responsible party
- Sponsor
- Investigators
- Jeroen Buijsen, MD PhD, Principal investigator, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409994
- Sponsor's protocol ID
- 04-16
- Status last verified
- Mar 2019
- First submitted
- 11 Dec 2006
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Testing Rapamycin, an mTOR-inhibitor, in Combination With Preoperative Radiotherapy in Operable Rectum Cancer: a Phase I and Phase II Study
- ClinicalTrials.gov ID
- NCT00409994
- Acronym / sponsor ID
- 04-16
- Conditions
- Rectum Cancer
- Keywords
- Colorectal cancer, M-tor inhibitor, Rapamycin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Academisch Ziekenhuis Maastricht
- Study start
- Sep 2006
- Primary completion
- 3 Aug 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 12 Dec 2006 (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.
Investigating the safety and the activity of Rapamycin, administered before and during preoperative radiotherapy in patients with an operable colorectal carcinoma. The phase I dose escalation study will be performed in three steps (2, 4 and 6 mg). Patients entered in phase II will follow the same tolerable treatment regimen as patients in phase I study.
Detailed description
Treatment regimen Phase I A daily dose of Rapamycin will be taken during 13 days. At step 1 a dose of 2 mg will be given once a day; at step 2 a dose of 4 mg will be given once a day; at step 3 a dose of 6 mg will be given once a day.
Preoperative radiotherapy (5x 5 Gy) will be administered at day 8-12, followed by TME-surgery at day 15.
Phase II A daily dose of 6 mg Rapamycin will be taken for 14 days (unless the optimal dose found in the phase I study is lower).
Preoperative radiotherapy (5x 5 Gy) will be administered at day 9-15, followed by TME-surgery 7-8 weeks post RT.
Sample size Phase I dose-escalation study Minimum 3 eligible patients per step, maximum 6 eligible patients per step. Phase II A total of 47 patients will be entered in this part of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rapamycine | Experimental | Drug: Rapamycinrapamycine 6 mg dd |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven rectum cancer
- UICC TNM I-III
- WHO performance status 0-2
- Less than 10% weight loss the last 6 months
- No recent (< 3 months) severe cardiac disease
Key exclusion criteria (5 listed)
- Concurrent chemotherapy with radiation
- History of prior pelvis radiotherapy
- Recent (<3 months) myocardial infarction
- Uncontrolled infectious disease
- Concurrent medication known as inhibitors of CYP3A4 susceptible to increase Rapamycin blood concentrations
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 |
|---|---|---|
| RapamycinAlso: Sirolimusdosis escalation: 2/4/6 mg rapamycin tablets, once daily during 13 days | Drug | Rapamycine |
Primary outcome
Phase I: Incidence of severe postoperative complications (grade IV or grade V),
Time frame: within the first 6 weeks after surgery
assessed according to CTCv3.0
Time frame: within the first 6 weeks after surgery
Phase II: Tumour blood flow assessed CT-PET + CTp
Time frame: day 64
4 secondary outcomes
Phase I:Incidence of other acute toxicity, assessed according to CTCv 3.0
Time frame: within the first 6 weeks after surgery
Activation status of mTor related and dependent molecules in the tumour
Time frame: within the first 6 weeks after surgery
Phase II:Maximum standardised Uptake Value (SUV) of 18F-FDG, assessed bij PET-CT-scan
Time frame: day 64
Phase II:Incidence of acute side effects of rapamycin, assessed according to CTCv 4.0
Time frame: day 8, 15, 22, 36, 50 and 64
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 18 Mar 2019.
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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.
Jeroen Buijsen, MD PhD principal investigator
Maastricht Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rapamycin in people with Rectum 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 6 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: finished, as of the sponsor's last update on 18 Mar 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Phase I: Incidence of severe postoperative complications (grade IV or grade V), (time frame: within the first 6 weeks after surgery). The study lists 3 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 18 Mar 2019.