Endometrial CarcinomaPhase 2/3CAN-STAMPNCT04159155
A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer
A Phase 2/3 study testing External Beam Radiation, Niraparib and Vaginal high-dose rate brachytherapy in people with Endometrial Carcinoma and P53 Mutation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is an umbrella, two-arm, multi-stage, phase II trial. The purpose of the trial in the early stage cohort is to determine if EBRT improves disease free survival (defined as the time from random assignment to disease recurrence or death from any cause) compared to vaginal brachytherapy after chemotherapy in women… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Carcinoma, P53 Mutation, Serous Carcinoma
- What is being tested?
- External Beam Radiation, Niraparib and Vaginal high-dose rate brachytherapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2020to 26 May 2025
- Phase
- Phase 2/3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with pure serous endometrial carcinoma will be included. Other histotypes (endometrioid and clear cell) with abnormal/mutant-type p53 is acceptable.
- Local TP53 results must be available for Central review.
- Patients diagnosed with stage I, II tumors will be enrolled in the early stage cohort.
- Patients suitable for an optimal surgery.
- Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%).
- Life expectancy of greater than 3 months.
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- Patients must have archival tissue available. If no tissue is available, tumor biopsy will be mandatory.
- Ability to understand and willing to sign a written informed consent document.
- Within 8 days of the proposed start of treatment, patients must have normal organ and marrow function.
- Women of child-bearing potential must agree to use effective contraceptive methods prior to study entry, during study participation, and for at least 30 days after the last administration of study medication.
Who cannot join
- Any other condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Mixed serous tumors without p53 aberration or with only subclonal p53 aberration
- Endometrial carcinosarcoma
- Patients being treated with radiotherapy within 4 weeks, or palliative radiotherapy encompassing >20% of the bone marrow within 1 week of starting study treatment.
- Patients who are receiving any other investigational agents.
- Participant has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage. Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.
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- Patients with evidence of fistula will be excluded.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study.
- Uncontrolled inter-current illness that would limit compliance with study requirements.
- Pregnant women are excluded.
- Known HIV-positive patients on antiretroviral therapy or active Hepatitis B or C are ineligible.
- Patients with a history of other malignancy ≤ 2 years prior to registration, with exceptions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line and Maintenance Treatment in Serous or p53 Mutant Endometrial Cancer
This is an umbrella, two-arm, multi-stage, phase II trial. The purpose of the trial in the early stage cohort is to determine if EBRT improves disease free survival (defined as the time from random assignment to disease recurrence or death from any cause) compared to vaginal brachytherapy after chemotherapy in women with serous or p53 aberrant endometrial cancer. The purpose of the trial in the advanced stage cohort is to determine if the maintenance with experimental treatment increases progression free survival, defined as the time from random assignment to disease progression or death from any cause.
Read the detailed description
SC represents a rare and aggressive histologic subtype of endometrial cancer, associated with a poor prognosis. Moreover, there are marked molecular differences between EC and SC, showing the need to separate clinical trials to develop the personalized treatment paradigms that have improved outcomes in other tumor types, such as breast and lung cancer. Given the absence of consensus between pathologists on the diagnosis of SC, this trial will also incorporate a molecular marker, p53abd.
Several studies have been done in early stage endometrial cancer including diverse histologies, stages and molecular characteristics. Due to the heterogeneity of the patients, there is a lack of knowledge on the best treatment strategy. Even in cases where disease is apparently confined to the endometrium, the rate of recurrence is high. The role of radiation therapy in the management of this disease, with a high propensity for distant failures, remains elusive.
Furthermore, women with endometrial cancer often have multiple comorbidities, needing to optimize the treatment strategies and toxicities. It then results crucial to identify a strategy that is effective and results in limited toxicity.
Advanced or recurrent SC has a poor prognosis. There are no maintenance strategies currently approved for endometrial cancer and this is under investigation.
- Conditions
- Endometrial Carcinoma, P53 Mutation, Serous Carcinoma
- Being tested
- External Beam Radiation, Niraparib, Vaginal high-dose rate brachytherapy, Observation - no drugs
- Medical subject headings
- Endometrial Neoplasms, Cystadenocarcinoma, Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam RadiationRadiation
Radiation therapy given outside the patient to a particular part of the body.
NiraparibDrug
Also called Zejula
Oral drug
Vaginal high-dose rate brachytherapyRadiation
Internal radiation to the vagina
Observation - no drugsOther
Observation
| Study group | Role | What they receive |
|---|---|---|
| Early Stage Cohort - Arm A | Experimental | Pelvic EBRT at 45Gy in 25 fractions, in 1.8Gy fractions daily, 5 days per week Receives: Radiation: External Beam Radiation |
| Early Stage Cohort - Arm B1 | Experimental | Vaginal high-dose rate brachytherapy 21 Gy in 3 fractions, prescribed to 5mm (i.e. 100% isodose at 5mm) from the cylinder/applicator surface and top along the upper third to half of the vagina (minimum 3cm, maximum 4cm). Receives: Radiation: Vaginal high-dose rate brachytherapy |
| Advanced Stage Cohort Arm C | Active comparator | Observation Receives: Other: Observation - no drugs |
| Advanced Stage Cohort Arm D1 | Experimental | Investigational agent (niraparib), orally, at a dose of 200 mg, or 300 mg, once daily, based on baseline platelet count and weight. Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival Rate
Time from random assignment until disease recurrence or death
Measured: 3 years
Secondary outcomes (2)
Overall Survival Rate
Time from enrollment until death.
Measured: 5 years
Number Adverse Events Experienced
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start17 Nov 2020
- Primary completion26 May 2025
- Study completion26 May 2025
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Oza, MD, Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159155
- Sponsor's protocol ID
- CAN-STAMP
- Other IDs
- CAPCR 19-6178
- Acronym
- CAN-STAMP
- Status last verified
- Aug 2025
- First submitted
- 7 Nov 2019
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Multi-arm Multi-stage Randomized Controlled Trial Assessing Front Line and Maintenance Treatment in Serous or p53 Mutant Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04159155
- Acronym / sponsor ID
- CAN-STAMP / CAN-STAMP
- Conditions
- Endometrial Carcinoma, P53 Mutation, Serous Carcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 26 May 2025 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 12 Nov 2019 (actual)
- 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.
This is an umbrella, two-arm, multi-stage, phase II trial. The purpose of the trial in the early stage cohort is to determine if EBRT improves disease free survival (defined as the time from random assignment to disease recurrence or death from any cause) compared to vaginal brachytherapy after chemotherapy in women with serous or p53 aberrant endometrial cancer. The purpose of the trial in the advanced stage cohort is to determine if the maintenance with experimental treatment increases progression free survival, defined as the time from random assignment to disease progression or death from any cause.
Detailed description
SC represents a rare and aggressive histologic subtype of endometrial cancer, associated with a poor prognosis. Moreover, there are marked molecular differences between EC and SC, showing the need to separate clinical trials to develop the personalized treatment paradigms that have improved outcomes in other tumor types, such as breast and lung cancer. Given the absence of consensus between pathologists on the diagnosis of SC, this trial will also incorporate a molecular marker, p53abd.
Several studies have been done in early stage endometrial cancer including diverse histologies, stages and molecular characteristics. Due to the heterogeneity of the patients, there is a lack of knowledge on the best treatment strategy. Even in cases where disease is apparently confined to the endometrium, the rate of recurrence is high. The role of radiation therapy in the management of this disease, with a high propensity for distant failures, remains elusive.
Furthermore, women with endometrial cancer often have multiple comorbidities, needing to optimize the treatment strategies and toxicities. It then results crucial to identify a strategy that is effective and results in limited toxicity.
Advanced or recurrent SC has a poor prognosis. There are no maintenance strategies currently approved for endometrial cancer and this is under investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early Stage Cohort - Arm A | Experimental | Radiation: External Beam RadiationPelvic EBRT at 45Gy in 25 fractions, in 1.8Gy fractions daily, 5 days per week |
| Early Stage Cohort - Arm B1 | Experimental | Radiation: Vaginal high-dose rate brachytherapyVaginal high-dose rate brachytherapy 21 Gy in 3 fractions, prescribed to 5mm (i.e. 100% isodose at 5mm) from the cylinder/applicator surface and top along the upper third to half of the vagina (minimum 3cm, maximum 4cm). |
| Advanced Stage Cohort Arm C | Active comparator | Other: Observation - no drugsObservation |
| Advanced Stage Cohort Arm D1 | Experimental | Drug: NiraparibInvestigational agent (niraparib), orally, at a dose of 200 mg, or 300 mg, once daily, based on baseline platelet count and weight. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with pure serous endometrial carcinoma will be included. Other histotypes (endometrioid and clear cell) with abnormal/mutant-type p53 is acceptable.
- Local TP53 results must be available for Central review.
- Patients diagnosed with stage I, II tumors will be enrolled in the early stage cohort.
- Patients suitable for an optimal surgery.
- Eastern Cooperative Group (ECOG) performance status ≤ 2 (Karnofsky ≥60%).
Key exclusion criteria (12 listed)
- Any other condition that would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Mixed serous tumors without p53 aberration or with only subclonal p53 aberration
- Endometrial carcinosarcoma
- Patients being treated with radiotherapy within 4 weeks, or palliative radiotherapy encompassing >20% of the bone marrow within 1 week of starting study treatment.
- Patients who are receiving any other investigational 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 |
|---|---|---|
| External Beam RadiationRadiation therapy given outside the patient to a particular part of the body. | Radiation | Early Stage Cohort - Arm A |
| NiraparibAlso: ZejulaOral drug | Drug | Advanced Stage Cohort Arm D1 |
| Vaginal high-dose rate brachytherapyInternal radiation to the vagina | Radiation | Early Stage Cohort - Arm B1 |
| Observation - no drugsObservation | Other | Advanced Stage Cohort Arm C |
Primary outcome
Disease Free Survival Rate
Time frame: 3 years
Time from random assignment until disease recurrence or death
2 secondary outcomes
Overall Survival Rate
Time frame: 5 years
Number Adverse Events Experienced
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Low accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Amit Oza, MD principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing External Beam Radiation, Niraparib and Vaginal high-dose rate brachytherapy in people with Endometrial Carcinoma and P53 Mutation, run by University Health Network, Toronto at 1 site in Canada.
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 12 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 12 Aug 2025. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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: Low accrual). 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?
Disease Free Survival Rate (time frame: 3 years). 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 12 Aug 2025.