Trial Outcomes & Findings for Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery (NCT NCT01958580)

NCT ID: NCT01958580

Last Updated: 2023-08-16

Results Overview

Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses

Results posted on

2023-08-16

Participant Flow

Three participants were enrolled into the study between 9/17/2013 and 6/17/2014.

Participant milestones

Participant milestones
Measure	Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT/EBRT) CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

patients were lost to followup and were not analyzed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT) n=3 Participants CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
Age, Categorical <=18 years	0 Participants n=5 Participants • patients were lost to followup and were not analyzed
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants • patients were lost to followup and were not analyzed
Age, Categorical >=65 years	0 Participants n=5 Participants • patients were lost to followup and were not analyzed
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses

Population: Data pertaining to Recurrence-free Survival was not collected/aggregated and therefore not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT) n=3 participants at risk CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 2 • Up to 1 year following completion of treatment (~69 weeks total)

Other adverse events

Other adverse events
Measure	Treatment (Gemcitabine, Docetaxel, Brachytherapy/IMRT, EBRT) n=3 participants at risk CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks. Gemcitabine Hydrochloride: Given IV Docetaxel: Given IV Internal Radiation Therapy: Undergo brachytherapy Intensity-Modulated Radiation Therapy: Undergo IMRT External Beam Radiation Therapy: Undergo EBRT Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 6 • Up to 1 year following completion of treatment (~69 weeks total)
Skin and subcutaneous tissue disorders Skin Hyperpigmentation	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
General disorders Edema Limbs	33.3% 1/3 • Number of events 2 • Up to 1 year following completion of treatment (~69 weeks total)
Metabolism and nutrition disorders Hyperkalemia	33.3% 1/3 • Number of events 2 • Up to 1 year following completion of treatment (~69 weeks total)
Renal and urinary disorders Nephrotoxicity	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
Musculoskeletal and connective tissue disorders Shoulder Pain	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
Nervous system disorders Peripheral Neuropathy	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
General disorders Fatigue	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)
Skin and subcutaneous tissue disorders Alopecia	33.3% 1/3 • Number of events 1 • Up to 1 year following completion of treatment (~69 weeks total)

Additional Information

Dr. Jessica Atrio - Professor, Department of Obstetrics & Gynecology and Women's Health

Albert Einstein College of Medicine - Montefiore Medical center

Phone: 917-721-6155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place