Trial Outcomes & Findings for Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer (NCT NCT03189446)

NCT ID: NCT03189446

Last Updated: 2024-03-08

Results Overview

Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 39 participants
• Primary outcome timeframe: 4 months
• Results posted on: 2024-03-08

Participant Flow

Participants were recruited at a single institution from October 2017 to July 2019. The first patient was enrolled on October 2, 2017 and the last patient was enrolled on July 23, 2019

Of 39 enrolled participants, 32 met inclusion criteria and evaluable then assign to the single arm treatment.

Participant milestones

Measure	Vaginal Cuff Brachytherapy + Chemotherapy 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Overall Study STARTED	32
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Vaginal Cuff Brachytherapy + Chemotherapy 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1

Baseline Characteristics

Vaginal Cuff Brachytherapy Followed by Chemotherapy in Endometrial Cancer

Baseline characteristics by cohort

Measure	Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Age, Continuous	64.5 years n=93 Participants
Sex: Female, Male Female	32 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=93 Participants
Region of Enrollment United States	32 participants n=93 Participants
Body Mass Index	35.1 kg/m^2 n=93 Participants

PRIMARY outcome

Timeframe: 4 months

Defined as completion of vaginal cuff brachytherapy followed by 3 cycles of dose dense paclitaxel and carboplatin chemotherapy

Outcome measures

Measure

Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Number of Patients Completing the Protocol

27 Participants

SECONDARY outcome

Timeframe: 4 months

Frequency and severity of adverse events as assessed by the CTCAE v4

Outcome measures

Measure

Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Frequency of Adverse Events Related to Acute Toxicity During Treatment

9 Participants

SECONDARY outcome

Timeframe: up to 2 years

Proportion of participants who experienced failure in regional or distant sites

Outcome measures

Measure

Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Sites of Failure

0 Participants

SECONDARY outcome

Timeframe: up to 2 years

Population: patients who received protocol therapy

time from study entry to the first tumor recurrence

Outcome measures

Measure

Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Recurrence-free Survival

NA months Only 3 patients recurred on study, therefore median recurrence free survival cannot be calculated.

SECONDARY outcome

Timeframe: up to 2 years

Population: Number of patients who died following protocol treatment

The contributing cause of death for patients with high risk endometrial cancer

Outcome measures

Measure	Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Contributing Cause of Death Unknown cause of death	1 Participants
Contributing Cause of Death Alive	31 Participants

SECONDARY outcome

Timeframe: up to 2 years

Population: Patients who received protocol treatment

time from study entry to death

Outcome measures

Measure

Vaginal Cuff Brachytherapy + Chemotherapy n=32 Participants 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles

Overall Survival

NA months Only 1 patient died on study, OS cannot be calculated

Adverse Events

Vaginal Cuff Brachytherapy + Chemotherapy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Vaginal Cuff Brachytherapy + Chemotherapy n=32 participants at risk 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 Vaginal Cuff Brachytherapy: Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted Carboplatin: Carboplatin IV on day 1 of a 21 day cycle for 3 cycles Paclitaxel: Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
Nervous system disorders Peripheral Neuropathy	6.2% 2/32 • Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.
General disorders Fatigue	6.2% 2/32 • Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.
Gastrointestinal disorders Diarrhea	6.2% 2/32 • Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.
Immune system disorders Taxol Reaction	9.4% 3/32 • Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.
Blood and lymphatic system disorders Anemia	6.2% 2/32 • Deaths were assessed for up to 2 years. Adverse events were assessed for up to 4 months.

Additional Information

Dr. Kathleen Moore

Stephenson Cancer Center

Phone: 405-271-8777

Email: Kathleen-Moore@ouhsc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place