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Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

Phase II Trial of Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy in Patients With Stage I-IIb Papillary Serous, Clear Cell and Endometrioid Endometrial Cancer With High-Intermediate Risk Factors

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00542490
Enrollment
23
Registered
2007-10-11
Start date
2007-09-30
Completion date
2016-02-29
Last updated
2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clear Cell Endometrial Cancer, Endometrial Cancer, Papillary Serous

Keywords

Endometrial cancer, Gynecologic Cancer, Vaginal Cuff Brachytherapy, Vaginal radiation

Brief summary

The purpose of this study is to determine the progression-free survival of patients with surgically staged, Stage I-II papillary serous, clear cell, or endometrioid carcinomas with high-intermediate risk factors treated by vaginal cuff brachytherapy followed by chemotherapy.

Detailed description

All patients must have undergone complete surgical staging including bilateral pelvic and para-aortic lymphadenectomy. All patients will receive radiation therapy. Treatment will be delivered either by LDR or HDR brachytherapy. The treatment plan must be started at the time of enrollment. The vaginal brachytherapy should be started within 4 weeks of surgery (within 2 weeks of enrollment), in order to avoid delays in initiation of systemic therapy, which should start on post-operative day 21. The dose will be prescribed to the vaginal (mucosal) surface as defined at the surface of the applicators. Following vaginal cuff radiation therapy, all patients will receive chemotherapy.

Interventions

RADIATIONVaginal Cuff Brachytherapy

Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All patients must have undergone specified complete surgical staging. * Patients must be surgically staged endometrial cancer patients at high-risk for recurrence. * Patients must have adequate bone marrow, renal and hepatic function.

Exclusion criteria

* Patients with recurrent disease. * Patients with GOG performance status of 3 or 4.

Design outcomes

Primary

MeasureTime frame
Number of Patients With Progression-free Survival at 2 Years2 years

Secondary

MeasureTime frame
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
Vaginal Cuff Brachytherapy
Vaginal Cuff Brachytherapy: Clinical stage I-II endometrial cancer surgically staged. Stage I-II with any high-intermediate risk (H-IR) features OR Stage IIb any histology OR Stage I-II Papillary Serous or Clear Cell Histology Vaginal cuff brachytherapy Followed by Paclitaxel (175 mg/m2 over 3 hours) and carboplatin (AUC 6) Chemotherapy X 3 (high risk)
23
Total23

Baseline characteristics

CharacteristicVaginal Cuff Brachytherapy
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
17 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
Age, Continuous69 years
Region of Enrollment
United States
23 Participants
Sex: Female, Male
Female
23 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 23
other
Total, other adverse events
1 / 23
serious
Total, serious adverse events
1 / 23

Outcome results

Primary

Number of Patients With Progression-free Survival at 2 Years

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Vaginal Cuff BrachytherapyNumber of Patients With Progression-free Survival at 2 Years19 Participants
Secondary

Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Vaginal Cuff BrachytherapyNumber of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy23 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026