Trial Outcomes & Findings for S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer (NCT NCT00445601)

Last Updated: 2020-01-18

Results Overview

Percentage of patients who experienced a recurrence of grade 1 or 2 superficial transitional cell cancer of the bladder between the date of registration and 24 months. Disease recurrence considered to occur at date of first observation of recurrent disease subsequently confirmed by biopsy. Patients without recurrence were censored at the time of their last cystoscopy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

406 participants

Primary outcome timeframe

Up to 2 Years

Results posted on

2020-01-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT. gemcitabine hydrochloride: Given intravesically	Arm II Patients receive intravesical placebo over 1 hour post-TURBT. placebo: Given intravesically
Overall Study STARTED	201	205
Overall Study Received TURBT	190	193
Overall Study COMPLETED	168	177
Overall Study NOT COMPLETED	33	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT. gemcitabine hydrochloride: Given intravesically	Arm II Patients receive intravesical placebo over 1 hour post-TURBT. placebo: Given intravesically
Overall Study Withdrawal by Subject	11	11
Overall Study TURBT Complication	12	8
Overall Study Incorrect Disease Status	6	6
Overall Study Drug Delivery Issue	2	2
Overall Study Adverse Event	2	0
Overall Study Death prior to TURBT	0	1

Baseline Characteristics

S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=201 Participants Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT. gemcitabine hydrochloride: Given intravesically	Arm II n=205 Participants Patients receive intravesical placebo over 1 hour post-TURBT. placebo: Given intravesically	Total n=406 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	24 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants	181 Participants n=7 Participants	344 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	186 Participants n=5 Participants	185 Participants n=7 Participants	371 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Occurence status First Occurence	128 Participants n=5 Participants	128 Participants n=7 Participants	256 Participants n=5 Participants
Occurence status Recurrent	66 Participants n=5 Participants	77 Participants n=7 Participants	143 Participants n=5 Participants
Occurence status Unknown	7 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants
Number of tumors 1	135 Participants n=5 Participants	140 Participants n=7 Participants	275 Participants n=5 Participants
Number of tumors >= 2	66 Participants n=5 Participants	65 Participants n=7 Participants	131 Participants n=5 Participants
Prior intravesical therapy Yes	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Prior intravesical therapy No	162 Participants n=5 Participants	166 Participants n=7 Participants	328 Participants n=5 Participants
Zubrod Performance Status 0	157 Participants n=5 Participants	165 Participants n=7 Participants	322 Participants n=5 Participants
Zubrod Performance Status 1	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants
Smoking history Current	49 Participants n=5 Participants	54 Participants n=7 Participants	103 Participants n=5 Participants
Smoking history Prior	98 Participants n=5 Participants	101 Participants n=7 Participants	199 Participants n=5 Participants
Smoking history Never	54 Participants n=5 Participants	46 Participants n=7 Participants	100 Participants n=5 Participants
Smoking history Unknown	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 Years

Population: Intent-to-Treat population

Outcome measures

Outcome measures
Measure	Arm I n=201 Participants Patients receive intravesical gemcitabine hydrochloride over 1 hour. gemcitabine hydrochloride: Given intravesically	Arm II n=205 Participants Patients receive intravesical placebo over 1 hour. placebo: Given intravesically
Disease Recurrence Rate	27.86 percentage of patients with recurrence	40 percentage of patients with recurrence

SECONDARY outcome

Timeframe: 4 years

Population: Intent-to-Treat Population

From date of registration to date of diagnosis of progressive disease. Censor at date of last disease assessment for those without progression.

Outcome measures

Outcome measures
Measure	Arm I n=201 Participants Patients receive intravesical gemcitabine hydrochloride over 1 hour. gemcitabine hydrochloride: Given intravesically	Arm II n=205 Participants Patients receive intravesical placebo over 1 hour. placebo: Given intravesically
Rate of Progression to Muscle Invasive Disease at 4 Years	2.49 percentage of patients with progression	4.39 percentage of patients with progression

SECONDARY outcome

Timeframe: Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT)

Population: All eligible patients who received instillation after TURBT and reported adverse events

Number of patients with Grade 3 through Grade 5 adverse events that are related to study drug

Outcome measures

Outcome measures
Measure	Arm I n=165 Participants Patients receive intravesical gemcitabine hydrochloride over 1 hour. gemcitabine hydrochloride: Given intravesically	Arm II n=174 Participants Patients receive intravesical placebo over 1 hour. placebo: Given intravesically
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Urinary frequency/urgency	0 Participants	2 Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Bladder spasms	0 Participants	1 Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Hemorrhage, GU - Bladder	1 Participants	0 Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Hemorrhage, GU - Urinary NOS	2 Participants	1 Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Infection-Other (Specify)	1 Participants	0 Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Pain - Bladder	0 Participants	1 Participants
Compare Qualitative and Quantitative Toxicities Between the Treatment Arms Pain - Urethra	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: TURBT data after patients stopped trial was not collected.

Compare whether treatment with post-TURBT intravesical instillation of gemcitabine vs placebo results in reduced long-term morbidity in patients, as defined by requirement for fewer TURBTs, courses of traditional intravesical therapies, and surveillance cystoscopies over 4 years.

Outcome measures

Outcome data not reported

Adverse Events

Arm I: Gemcitabine

Serious events: 7 serious events

Other events: 60 other events

Deaths: 17 deaths

Arm II: Placebo

Serious events: 5 serious events

Other events: 58 other events

Deaths: 25 deaths

Serious adverse events

Serious adverse events
Measure	Arm I: Gemcitabine n=165 participants at risk Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.	Arm II: Placebo n=174 participants at risk Patients receive intravesical placebo over 1 hour post-TURBT.
Cardiac disorders Cardiac General-Other	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Infections and infestations Infection with unknown ANC - Blood	0.00% 0/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.57% 1/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Infections and infestations Infection with unknown ANC - Urinary tract NOS	0.00% 0/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.57% 1/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Infections and infestations Infection-Other	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor flare	0.00% 0/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.57% 1/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Nervous system disorders CNS cerebrovascular ischemia	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Nervous system disorders Vasovagal episode	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Hemorrhage, GU - Bladder	1.2% 2/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	0.00% 0/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.57% 1/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Obstruction, GU - Bladder	0.00% 0/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.57% 1/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Obstruction, GU - Ureter	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Pain - Bladder	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Renal failure	0.61% 1/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.00% 0/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).

Other adverse events

Other adverse events
Measure	Arm I: Gemcitabine n=165 participants at risk Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.	Arm II: Placebo n=174 participants at risk Patients receive intravesical placebo over 1 hour post-TURBT.
Gastrointestinal disorders Nausea	6.7% 11/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	1.7% 3/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Gastrointestinal disorders Vomiting	5.5% 9/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	0.57% 1/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Bladder spasms	7.9% 13/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	5.2% 9/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Hemorrhage, GU - Urinary NOS	9.7% 16/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	10.9% 19/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Pain - Bladder	13.9% 23/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	13.2% 23/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Urinary frequency/urgency	15.2% 25/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	14.4% 25/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).
Renal and urinary disorders Urinary retention (including neurogenic bladder)	5.5% 9/165 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).	5.7% 10/174 • Assessed every 3 months for 2 years, then every 6 months for 2 years Participants were monitored for toxicity at Week 1 and 2 after protocol treatment, with an additional assessment at Week 4 if any toxicities noted during the first two weeks. Patients were then monitored every 3 weeks for the first 2 years following protocol treatment, and then every 6 months for the following 2 years (up to 4 years).

Additional Information

Catherine Tangen, Genitourinary Committee Statistician

SWOG Statistics and Data Management Center

Phone: 206-667-2933

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place