Trial Outcomes & Findings for Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer (NCT NCT00542490)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

23 participants

Primary outcome timeframe

2 years

Results posted on

2020-08-21

Participant milestones
Measure	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)
Overall Study STARTED	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	2

Withdrawal data not reported

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Patients With Endometrioid Cancer

Baseline characteristics by cohort
Measure	Vaginal Cuff Brachytherapy n=23 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	23 Participants n=5 Participants

Timeframe: 2 years

Outcome measures
Measure	Vaginal Cuff Brachytherapy n=23 Participants 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)
Number of Patients With Progression-free Survival at 2 Years	19 Participants

Timeframe: 2 years

Outcome measures
Measure	Vaginal Cuff Brachytherapy n=23 Participants 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)
Number of Patients With at Least One Toxicity Related to Vaginal Cuff Brachytherapy Followed by Carboplatin and Paclitaxel Chemotherapy	23 Participants

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events
Measure	Vaginal Cuff Brachytherapy n=23 participants at risk 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)
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	4.3% 1/23 • Number of events 1 • 2 years
Gastrointestinal disorders Gastrointestinal bleed	4.3% 1/23 • Number of events 1 • 2 years
Blood and lymphatic system disorders neutropenic fever	4.3% 1/23 • Number of events 1 • 2 years

Other adverse events
Measure	Vaginal Cuff Brachytherapy n=23 participants at risk 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)
General disorders Grade 4 Fatigue	4.3% 1/23 • Number of events 1 • 2 years

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