Trial Outcomes & Findings for Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery (NCT NCT00777491)

Last Updated: 2022-06-15

Results Overview

Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

70 participants

Primary outcome timeframe

From randomization to three years

Results posted on

2022-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	5-FU and Cisplatin + BID Irradiation Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID \[twice daily\] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD \[once a day\] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Overall Study STARTED	35	35
Overall Study Eligible	33	33
Overall Study Has 3-year Efficacy Data	27	25
Overall Study Started Induction Therapy	33	33
Overall Study Started Consolidation Therapy	29	25
Overall Study Started Adjuvant Therapy	32	31
Overall Study Has Adverse Event Data (Treatment)	33	33
Overall Study Has Adverse Event Data (Late)	32	31
Overall Study Has 3 Year AUASI Data	6	6
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	5-FU and Cisplatin + BID Irradiation Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID \[twice daily\] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD \[once a day\] radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Overall Study Protocol Violation	0	2
Overall Study Did not receive any protocol treatment	2	0

Baseline Characteristics

Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Bladder Cancer That Was Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	5-FU and Cisplatin + BID Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Total n=66 Participants Total of all reporting groups
Age, Customized <= 49 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Customized 50-59 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age, Customized 60-69 years	13 Participants n=5 Participants	20 Participants n=7 Participants	33 Participants n=5 Participants
Age, Customized >= 70 years	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	33 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Zubrod Performance Status 0	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Zubrod Performance Status 1	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
T Stage cT2	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
T Stage cT3-T4a	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization to three years

Population: Eligible patients with 3-year data

Distant metastasis occurrence is defined as the first appearance of disease (with radiographic evidence) in a non-regional lymph node, solid organ or bone.

Outcome measures

Outcome measures
Measure	5-FU and Cisplatin + BID Irradiation n=27 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=25 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Percentage of Patients Without Distant Metastases by Three Years	77.8 percentage of participants Interval 64.3 to One-sided confidence interval	84.0 percentage of participants Interval 70.5 to One-sided confidence interval

SECONDARY outcome

Timeframe: After each treatment component (induction, consolidation, adjuvant). Timing varies bases on arm, tumor response at multiple time points, and allowed time ranges.

Population: Eligible patients who started each treatment component (induction, consolidation, adjuvant)

Treatment administration data was centrally reviewed to determine if patients completed each treatment component per protocol.

Outcome measures

Outcome measures
Measure	5-FU and Cisplatin + BID Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Percentage of Patients Who Completed Treatment Per Protocol Consolidation Therapy	27 Participants	23 Participants
Percentage of Patients Who Completed Treatment Per Protocol Induction Therapy	32 Participants	31 Participants
Percentage of Patients Who Completed Treatment Per Protocol Adjuvant Therapy	18 Participants	17 Participants

SECONDARY outcome

Timeframe: From start of treatment to 180 days after the end of treatment. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.

Population: Eligible patients with adverse event data for corresponding time period

Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. All adverse events are counted, regardless of reported relationship to protocol treatment.

Outcome measures

Outcome measures
Measure	5-FU and Cisplatin + BID Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events During Treatment	19 Participants	18 Participants
Percentage of Patients With Grade 3 or Higher Genitourinary, Gastrointestinal, or Hematologic Adverse Events Between End of Treatment and 180 days after	8 Participants	5 Participants

SECONDARY outcome

Timeframe: 3-4 weeks following induction therapy (approximately maximum 8 weeks from start of treatment depending on treatment arm and allowed time windows)

Population: Eligible patients who started induction therapy

Patients will be considered as having a clinical complete response when all biopsies are negative at the site(s) of the pretreatment tumor(s).

Outcome measures

Outcome measures
Measure	5-FU and Cisplatin + BID Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=33 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Number of Patients Experiencing Complete Response of the Primary Tumor After Induction Therapy	29 Participants	25 Participants

SECONDARY outcome

Timeframe: From start of treatment to five years after the end of therapy. Treatment could last up to 40 weeks depending on arm, tumor response, and allowed time ranges.

Population: Eligible participants with five-year data

Progression is defined as an increase of 50% or more in the largest diameter of the endoscopically appreciable tumor in the tumor-site biopsy specimen, the development of new bladder tumors, or the development of metastatic disease.

Outcome measures

Outcome measures
Measure	5-FU and Cisplatin + BID Irradiation n=27 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=22 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Number of Participants With Progression or Removal of Bladder Five Years After Therapy	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Baseline and 3 years

Population: Eligible patients with baseline and 3-year scores

The AUASI is a validated 7-item measure used to assess urinary symptoms. A higher score indicates more severe symptoms for the individual questions and overall total. Six questions ask about frequency of symptoms over the past month with possible responses: 0= Not at all; 1 = Less than 1 time in 5; 2 = less than half the time, 3 = About half the time, 4 = More than half the time, 5 = Almost always. An additional question asks the number of times one gets up to urinate after going to bed, with response indicating the exact number of times ranging from 0 to 5. The total score is the sum of the questions and ranges from 0 to 35. Change is calculated as 3-year score - baseline score such that a negative change indicates improvement.

Outcome measures

Outcome measures
Measure	5-FU and Cisplatin + BID Irradiation n=6 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction 5-fluorouracil, induction cisplatin, induction BID radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation 5-fluorouracil, consolidation cisplatin, consolidation BID radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine, adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.	Gemcitabine + QD Irradiation n=6 Participants Within 8 weeks following pre-study transurethral resection (TUR) patients receive 2.5 weeks of induction chemoradiotherapy (induction gemcitabine and induction QD radiation therapy). Consolidation chemoradiotherapy begins 7-14 days following post-induction chemoradiotherapy endoscopic response evaluation. Patients achieving a complete response receive 1.5 weeks of consolidation chemoradiotherapy (consolidation gemcitabine and consolidation QD radiation therapy). Patients without a complete response undergo radical cystectomy. Outpatient adjuvant chemotherapy (adjuvant gemcitabine and adjuvant cisplatin) begins 4-5 weeks following the post-consolidation endoscopic evaluation or 8-12 weeks following radical cystectomy, and continues for 12 weeks.
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years Sensation of Not Emptying Bladder	-0.50 units on a scale Interval -4.0 to 0.0	0.0 units on a scale Interval -3.0 to 3.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years Urinate Again < 2 Hours After Urinating	-2.50 units on a scale Interval -5.0 to 2.0	-1.0 units on a scale Interval -4.0 to 4.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years Stopped and Started When Urinating	-1.00 units on a scale Interval -5.0 to 1.0	0.00 units on a scale Interval -1.0 to 2.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years Difficult to Postpone Urination	-3.00 units on a scale Interval -5.0 to 0.0	-0.50 units on a scale Interval -3.0 to 4.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years Weak Urinary Stream	-0.50 units on a scale Interval -5.0 to 0.0	0.00 units on a scale Interval -2.0 to 5.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years Push or Strain to Begin Urination	-0.50 units on a scale Interval -5.0 to 2.0	0.00 units on a scale Interval -1.0 to 0.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years How Often Get Up at Night to Urinate	-3.50 units on a scale Interval -4.0 to 4.0	-1.50 units on a scale Interval -2.0 to 4.0
Change in American Urological Association Symptom Index (AUASI) Score at 3 Years AUA Total Symptom Score	-9.50 units on a scale Interval -33.0 to 6.0	-3.50 units on a scale Interval -12.0 to 22.0

SECONDARY outcome

Timeframe: The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from the NRG tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this out

Population: The protocol did not provide sufficient detail to meet National Cancer Institute requirements for release of specimens from our tissue bank for the protocol-specified analysis, therefore no assays were performed and no data were collected for this outcome measure. Specimen use will require federal approval and funding separate from this trial.

Outcome measures

Outcome data not reported

SECONDARY outcome

Outcome measures

Outcome data not reported

Adverse Events

Arm I

Serious events: 11 serious events

Other events: 33 other events

Deaths: 16 deaths

Arm II

Serious events: 8 serious events

Other events: 33 other events

Deaths: 11 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Phone: 215-574-3208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Arm I n=33 participants at risk Patients receive induction therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising fluorouracil IV, cisplatin IV, and radiotherapy in weeks 8-10.	Arm II n=33 participants at risk Patients receive induction therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 1-4. Patients then undergo either radical cystectomy or receive consolidation therapy comprising gemcitabine hydrochloride IV and radiotherapy in weeks 8-10.
Blood and lymphatic system disorders Febrile neutropenia	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Cardiac disorders Atrial fibrillation	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Cardiac disorders Cardiac disorder	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Abdominal pain	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Colitis	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Colonic perforation	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Diarrhea	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	6.1% 2/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Gastrointestinal disorder	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Mucositis oral	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Nausea	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Gastrointestinal disorders Vomiting	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
General disorders Fever	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
General disorders Pain [other]	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Infections and infestations Bladder infection [with normal or Grade 1-2 ANC]	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Infections and infestations Bladder infection [with unknown ANC]	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Infections and infestations Catheter related infection [with Grade 3-4 ANC]	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Infections and infestations Infection [other]	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Infections and infestations Pneumonia [with normal or Grade 1-2 ANC]	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Infections and infestations Urinary tract infection [with unknown ANC]	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Injury, poisoning and procedural complications Intraoperative complications	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Investigations Leukopenia	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Investigations Neutrophil count decreased	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Investigations Platelet count decreased	15.2% 5/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Metabolism and nutrition disorders Dehydration	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Metabolism and nutrition disorders Hypokalemia	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Nervous system disorders Depressed level of consciousness	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Nervous system disorders Intracranial hemorrhage	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Nervous system disorders Ischemia cerebrovascular	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Nervous system disorders Syncope	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Psychiatric disorders Confusion	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Psychiatric disorders Depression	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Renal and urinary disorders Renal failure	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.
Vascular disorders Thrombosis	3.0% 1/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.	0.00% 0/33 • From randomization to last follow-up. Maximum follow-up was 11.4 years. Adverse event population = eligible patients who started protocol treatment.