NCT03189446 · REGISTRY CONDITION SEARCH

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2024-03-08

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Number of Patients Completing the Protocol

→

outcome · POSTED

Frequency of Adverse Events Related to Acute Toxicity During Treatment

→

outcome · POSTED

Sites of Failure

→

outcome · POSTED

Recurrence-free Survival

→

outcome · POSTED

Contributing Cause of Death

→

outcome · POSTED

Overall Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→

Who could take part

eligibility Criteria: Inclusion Criteria: 1. All patients must have undergone hysterectomy. Bilateral salpingooophorectomy is strongly encouraged but not mandatory. 2. Pelvic and para-aortic lymphadenectomy are optional, but strongly encouraged. Peritoneal washing are optional. 3. 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. 4. 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: 1. 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. 2. Patients with Stage II endometrial carcinoma (any histology) with cervical stromal invasion. (occult or gross involvement), with or without high-intermediate risk factors. 3. 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). 5. Patients must have GOG performance status 0, 1, or 2. 6. Patients must have adequate bone marrow, renal, hepatic and neurologic function per protocol. 7. Patients who have met the pre-entry requirements specified in protocol; testing values/results must meet eligibility criteria specified in protocol. 8. Patients must have signed an approved informed consent and authorization permitting release of personal health information. Exclusion Criteria: 1. Patients with recurrent disease. 2. Patients with GOG performance status of 3 or 4. 3. Greater than 12 weeks elapsed from surgery to enrollment. 4. Patients have prior pelvic or abdominal radiation therapy. 5. Known hypersensitivity to any component of study treatment that resulted in drug discontinuation. 6. 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 7. Active pregnancy or lactation. 8. Prior malignancy requiring treatment within the last 3 years.
healthy Volunteers: false
maximum Age: 99 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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
intervention Names
Radiation: Vaginal Cuff Brachytherapy
Drug: Carboplatin
Drug: Paclitaxel
label
Vaginal Cuff Brachytherapy + Chemotherapy
type
EXPERIMENTAL

interventions

arm Group Labels
Vaginal Cuff Brachytherapy + Chemotherapy
description
Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted
name
Vaginal Cuff Brachytherapy
type
RADIATION
arm Group Labels
Vaginal Cuff Brachytherapy + Chemotherapy
description
Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
name
Carboplatin
type
DRUG
arm Group Labels
Vaginal Cuff Brachytherapy + Chemotherapy
description
Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
name
Paclitaxel
type
DRUG

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 39
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy
measure
Number of Patients Completing the Protocol
time Frame
4 months

secondary Outcomes

description
Frequency and severity of adverse events as assessed by the CTCAE v4
measure
Frequency of Adverse Events Related to Acute Toxicity During Treatment
time Frame
4 months
description
Proportion of participants who experienced failure in regional or distant sites
measure
Sites of Failure
time Frame
up to 2 years
description
time from study entry to the first tumor recurrence
measure
Recurrence-free Survival
time Frame
up to 2 years
description
The contributing cause of death for patients with high risk endometrial cancer
measure
Contributing Cause of Death
time Frame
up to 2 years
description
time from study entry to death
measure
Overall Survival
time Frame
up to 2 years

Full study description

brief 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.
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.

Source references

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-7adec6b32aa3e6a2db7f
requested nct id
NCT03189446
primary nct id
NCT03189446
source kind
ctgov_condition_query
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vaginal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
source record id
Source null
source file sha256
b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
payload sha256
d78e5c995574e28bacf9f54ec570d3e66434eefa0a6a1df8b67ccd17ca7dfdfc
payload
clinical indication matching status
condition_index_match_asserted_by_registry_not_reviewed
end exclusive
true
id
nct-edge-7adec6b32aa3e6a2db7f
link basis
returned_by_explicit_condition_and_posted_results_filter_query
nct id
NCT03189446
occurrences
context exact
NCT03189446
end
11
exact text
NCT03189446
start
0
offset unit
unicode_code_points
query cond
Vaginal Cancer
query disease state id
ds-vaginal-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vaginal-cancer-000.json
source file sha256
b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
source json pointer
/studies/29/protocolSection/identificationModule/nctId
source kind
ctgov_condition_query
source record id
Source null
source string basis
parsed_JSON_string_unmodified
source string sha256
4e6a93e212ca3cb74cfbeb65d84eb7733aa854960fbcc010ea6c1682b99d41ab
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vaginal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice