Trial Outcomes & Findings for Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer (NCT NCT02716896)

Results Overview

Number of randomized participants that progressed to one year on treatment

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

One year

Results posted on

2019-11-25

Participant Flow

Participant milestones

Participant milestones
Measure	Surgery (Radical Cystectomy) In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen. Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group.	Radiation and Chemoradiation Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Overall Study STARTED	1	1
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Surgery (Radical Cystectomy) In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen. Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group.	Radiation and Chemoradiation Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Overall Study Physician Decision	0	1

Baseline Characteristics

Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Surgery (Radical Cystectomy) n=1 Participants In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen. Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group.	Radiation and Chemoradiation n=1 Participants Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White-non Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: There were no study completers in either arm of the study at 1 year. The one subject randomized to surgery but disease state worsened and subject did not complete to one year. Since the participant did not progress to one year on treatment, no analysis was possible. Data were not collected.

Number of randomized participants that progressed to one year on treatment

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: Subject in the Radiation and Chemoradiation arm was withdrawn by the PI due to progression of disease

Number of randomized participants who were withdrawn from the study by the investigator, or who voluntarily withdrew

Outcome measures

Outcome measures
Measure	Surgery (Radical Cystectomy) n=1 Participants In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen. Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group.	Radiation and Chemoradiation Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Total Number of Participants Withdraw From the Study	1 Participants	0 Participants

PRIMARY outcome

Timeframe: One year

Population: Subject was withdrawn from radiation and chemoradiation arm of the study by PI due to progression of disease

Number of randomized subjects who completed the study to one year

Outcome measures

Outcome measures
Measure	Surgery (Radical Cystectomy) n=1 Participants In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen. Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group.	Radiation and Chemoradiation Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Total Number of Participants Completed the Study	1 Participants	0 Participants

SECONDARY outcome

Timeframe: One year

Population: Data collected for this outcome were not analysed due to limited funds and early study termination. Only one subject was randomized to intervention and so insufficient data were collected for analysis.

Questionnaires such as FACT-Bl (functional assessment of cancer therapyfor patients with bladder cancer), Katz ADL (Katz Index of Independence in Activities of Daily Living), and EORTC (European Organization for Research and Treatment of Cancer), all surveys used to assess quality of life, will be used to measure the changes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: Only the subject who had radical cystectomy progressed to completion after bladder removal, so zero participants kept their bladder, so no data were collected.

Number of participants that were randomized who did not have bladder cystectomy during the one year study period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: Only the participant randomized to radical cystectomy progressed to study completion

Number of participants who completed the study whose disease state did not worsen during participation

Outcome measures

Outcome measures
Measure	Surgery (Radical Cystectomy) n=1 Participants In brief, radical cystectomy is the removal of the entire bladder, nearby lymph nodes (lymphadenectomy), part of the urethra, and nearby organs that may contain cancer cells. In men the prostate, the seminal vesicles, and part of the vas deferens are also removed. In women the cervix, the uterus, the ovaries, the fallopian tubes, and part of the vagina are also removed. Participants in this group may also undergo neoadjuvant chemotherapy prior to the surgery. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, and availability of chemotherapeutic regimen. Radical cystectomy: Radical cystectomy will be performed on those who are randomized to this group.	Radiation and Chemoradiation Those randomized to this group will undergo systematic chemotherapy and radiation. In brief, participants will receive 33-36 daily fractions of radiation therapy 5 days a week. Concurrently, radiosensitizing chemotherapy involves either cisplatin plus 5-fluorouracil (5-FU) or mitomycin C (MMC) plus 5-FU. Other concurrent chemotherapy regimens utilized include paclitaxel and gemcitabine. The decision for specific chemotherapy regimen is based on numerous variables such as participant's comorbidities, GFR, participant's preference, availability of chemotherapeutic regimen. Radiation and chemoradiation: Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
Total Number of Participants Who Remained Progression-free Within the Time Frame of the Study	1 Participants	—

SECONDARY outcome

Timeframe: One year

Population: No subjects that were randomized and completed the study had chemoradiation, so no data were collected for this outcome.

Genomic markers will be isolated from the research biological samples, and then measured by tissue RNA microarray.

Outcome measures

Outcome data not reported

Adverse Events

Surgery (Radical Cystectomy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Radiation and Chemoradiation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dharam Kaushik

University of Texas Health San Antonio

Phone: 210-567-5676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place