Trial Outcomes & Findings for A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma (NCT NCT00231868)

Results Overview

Overall survival analysis of early stage (stage 1 \& 2) and late stage (stage 3 \& 4)UPSC patients who were prescribed radiation "sanwhiched" between three cycles of paclitaxel/platinum chemotherapy before and after RT. Outcome measures were Progression Free Survival (PFS) and Overall Survival (OS).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

81 participants

Primary outcome timeframe

Up to 7 years

Results posted on

2020-08-12

Participant Flow

Participant milestones

Participant milestones
Measure	Carboplatin & Paclitaxel & Radiation: Pelvic Radiation Therapy Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy Carboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles Carboplatin and Paclitaxel and Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
Overall Study STARTED	81
Overall Study COMPLETED	65
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Radiation Therapy and Paclitaxel and Carboplatin in Patients With Uterine Papillary Serous Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Drug:Carboplatin, Paclitaxel & Radiation n=72 Participants Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy Carboplatin and Paclitaxel and Pelvic Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles Carboplatin and Paclitaxel and Radiation Therapy : Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 years

Population: Kaplan-Meier survival analysis of Progression Free Survival (PFS) and Overall Survival (OS).

Overall survival analysis of early stage (stage 1 \& 2) and late stage (stage 3 \& 4)UPSC patients who were prescribed radiation "sanwhiched" between three cycles of paclitaxel/platinum chemotherapy before and after RT. Outcome measures were Progression Free Survival (PFS) and Overall Survival (OS).

Outcome measures

Outcome measures
Measure	Drug:Carboplatin, Paclitaxel & Radiation n=72 Participants Drug:Carboplatin and Paclitaxel and Radiation: Pelvic Radiation Therapy Carboplatin and Paclitaxel and Pelvic Radiation Therapy: Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles Carboplatin and Paclitaxel and Radiation Therapy: Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=6.5) Repeat q 21 days x 3 cycles followed by RT followed by Paclitaxel 175 mg/m2/3 hour \& Carboplatin (AUC=5.0)Repeat q 21 days x 3 cycles
To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC Early stage (PFS)	65.5 months Standard Error 3.6
To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC Late stage (PFS)	25.8 months Standard Error 3.0
To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC Early stage (OS)	76.5 months Standard Error 4.3
To Evaluate the Toxicity and Tolerability of Pelvic Radiation "Sandwiched" Between Cycles of Paclitaxel/Carboplatin Chemotherapy in Patients With UPSC Late stage (OS)	35.9 months Standard Error 5.3

Adverse Events

Carboplatin & Paclitaxel & Radiation: Pelvic Radiation Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Dennis Yi-Shin Kuo

Montefiore Medical Center

Phone: 718-405-8082

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place