Endometrial CancerPhase 2NCT03189446
Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer
A Phase 2 study testing Vaginal Cuff Brachytherapy, Carboplatin and Paclitaxel in people with Endometrial Cancer and Papillary Serous, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Endometrial Cancer, Papillary Serous, Clear Cell Endometrial Cancer
- What is being tested?
- Vaginal Cuff Brachytherapy, Carboplatin and Paclitaxel
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 6 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory.
- Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional.
- If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed.
- All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
- age ≥18 years with 3 risk factors
- Risk factors:
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- Grade 2 or 3 tumor, (+) lymphovascular space invasion, outer ½ myometrial invasion. Patients with these risk criteria may be enrolled with either positive or negative cytology.
- Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors.
- Patients with serous or clear cell histology (with or without other high-intermediate risk factors) are eligible provided the disease is uterine-confined (with or without cervical stromal invasion or endocervical glandular involvement).
- Patients must have GOG performance status 0, 1, or 2.
- Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol.
- Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol.
- Patients must have signed an approved informed consent and authorization permitting release of personal health information.
Who cannot join
- Patients with recurrent disease.
- Patients with GOG performance status of 3 or 4.
- Greater than 12 weeks elapsed from surgery to enrollment.
- Patients have prior pelvic or abdominal radiation therapy.
- Known hypersensitivity to any component of study treatment that resulted in drug discontinuation.
- Significant intercurrent illness including, but not limited to, unstable angina pectoris, and cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- Active pregnancy or lactation.
- Prior malignancy requiring treatment within the last 3 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.
Read the detailed description
Before the patient begins the study:
Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.
Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care.
Treatment:
All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy.
Study participation will be up to two years.
- Being tested
- Vaginal Cuff Brachytherapy, Carboplatin, Paclitaxel
- Keywords
- Endometrial Cancer, Gynecologic Cancer, radiation therapy
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal Cuff BrachytherapyRadiation
Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted
CarboplatinDrug
Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
PaclitaxelDrug
Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Cuff Brachytherapy + Chemotherapy | Experimental | Vaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles Receives: Radiation: Vaginal Cuff Brachytherapy; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Completing the Protocol
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
Measured: 4 months
Secondary outcomes (5)
Frequency of Adverse Events Related to Acute Toxicity During Treatment
Frequency and severity of adverse events as assessed by the CTCAE v4
Measured: 4 months
Sites of Failure
Proportion of participants who experienced failure in regional or distant sites
Measured: up to 2 years
Recurrence-free Survival
time from study entry to the first tumor recurrence
Measured: up to 2 years
Contributing Cause of Death
The contributing cause of death for patients with high risk endometrial cancer
Measured: up to 2 years
Overall Survival
time from study entry to death
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start2 Oct 2017
- Primary completion13 Dec 2019
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathleen Moore, MD, Principal investigator, Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03189446
- Sponsor's protocol ID
- 7964
- Status last verified
- Mar 2024
- First submitted
- 24 May 2017
- Last updated
- 8 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Vaginal Cuff Brachytherapy Followed by Adjuvant Chemotherapy With Carboplatin and Dose Dense Paclitaxel in Patients With High-Risk Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03189446
- Acronym / sponsor ID
- 7964
- Keywords
- Endometrial Cancer, Gynecologic Cancer, radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 16 Jun 2017 (actual)
- Results
- Posted 12 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of treatment in patients with high risk endometrial cancer treated by vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy.
Detailed description
Before the patient begins the study:
Endometrial cancer is commonly treated with surgery. The patient must have already had surgery including hysterectomy (removal of the uterus) prior to being considered eligible for this study. The surgery may also include removal of pelvic and para-aortic lymph nodes. Following the surgery, the doctor will identify if the patient has factors related to the cancer which places the patient at a greater risk for the cancer returning.
Prior to participating in this study there are exams, tests or procedures to find out if the patient can be treated in the study. Most are part of regular cancer care.
Treatment:
All patients will receive radiation therapy followed by three cycles of dose dense paclitaxel and carboplatin chemotherapy. Radiation therapy will be delivered either by LDR or HDR brachytherapy and must be specified at the time of enrollment. The vaginal brachytherapy should be started within 12 weeks of surgery (within 2 weeks of enrollment). Chemotherapy should start within 3 weeks of initiating brachytherapy.
Study participation will be up to two years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaginal Cuff Brachytherapy + Chemotherapy | Experimental | Radiation: Vaginal Cuff Brachytherapy, Drug: Carboplatin, Drug: PaclitaxelVaginal cuff brachytherapy followed by Carboplatin (AUC 6) on day 1and Paclitaxel 80 mg/m2 IV over 1 hour days 1, 8, and 15 X 3 total cycles |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory.
- Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional.
- If either a bilateral salpingo-oophorectomy or nodal dissection was not performed, post-operative pre-treatment CT/MRI is required and must not demonstrate evidence suggestive of metastatic disease (adnexa, nodes, intraperitoneal disease). Post-operative, pre-treatment CT/MRI must be performed if a pelvic and para-aortic nodal dissection was not performed.
- All patients will be staged according to the FIGO 2009 staging system and with endometrial carcinoma (endometrioid types) confined to the corpus uteri or with endocervical glandular involvement fitting one of the following high-intermediate risk factor categories:
- Patients must have GOG performance status 0, 1, or 2.
Key exclusion criteria (8 listed)
- Patients with recurrent disease.
- Patients with GOG performance status of 3 or 4.
- Greater than 12 weeks elapsed from surgery to enrollment.
- Patients have prior pelvic or abdominal radiation therapy.
- Known hypersensitivity to any component of study treatment that resulted in drug discontinuation.
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 |
|---|---|---|
| Vaginal Cuff BrachytherapyWithin 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted | Radiation | Vaginal Cuff Brachytherapy + Chemotherapy |
| CarboplatinCarboplatin IV on day 1 of a 21 day cycle for 3 cycles | Drug | Vaginal Cuff Brachytherapy + Chemotherapy |
| PaclitaxelPaclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles | Drug | Vaginal Cuff Brachytherapy + Chemotherapy |
Primary outcome
Number of Patients Completing the Protocol
Time frame: 4 months
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
5 secondary outcomes
Frequency of Adverse Events Related to Acute Toxicity During Treatment
Time frame: 4 months
Sites of Failure
Time frame: up to 2 years
Recurrence-free Survival
Time frame: up to 2 years
Contributing Cause of Death
Time frame: up to 2 years
Overall Survival
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kathleen Moore, MD principal investigator
Stephenson Cancer Center
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 Vaginal Cuff Brachytherapy, Carboplatin and Paclitaxel in people with Endometrial Cancer and Papillary Serous, run by University of Oklahoma at 1 site in United States.
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 13 inclusion and 8 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 8 Mar 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 United States. 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?
Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Completing the Protocol (time frame: 4 months). 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 8 Mar 2024.