NCT00045630 · REGISTRY CONDITION SEARCH

S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2013-05-27

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: DISEASE CHARACTERISTICS: * Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder * Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed * The following diagnoses are not allowed: * Small cell carcinoma * Sarcomatoid components * Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present * Residual disease after second TURBT allowed * No more than 14-56 days after second TURBT * No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis * Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * White blood cell count (WBC) at least 3,500/mm\^3 * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least lower limit of normal Hepatic * Bilirubin no greater than 1.5 mg/dL * Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal Renal * Creatinine no greater than 2.0 mg/dL AND/OR * Creatinine clearance at least 60 mL/min Other * No prohibitive medical risk that would preclude radical cystectomy * No other serious concurrent systemic disorder that would preclude study compliance * No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease-free for 5 years * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Prior intravesical immunotherapy allowed Chemotherapy * No prior systemic chemotherapy for TCC of the urothelium * Prior intravesical chemotherapy allowed Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for TCC of the urothelium * No concurrent radiotherapy Surgery * See Disease Characteristics
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Gemcitabine, Paclitaxel, Carboplatin followed by surgery
intervention Names
Drug: carboplatin
Drug: gemcitabine
Drug: paclitaxel
Procedure: surgery
label
Gemcitabine, Paclitaxel, Carboplatin
type
EXPERIMENTAL

interventions

arm Group Labels
Gemcitabine, Paclitaxel, Carboplatin
name
carboplatin
type
DRUG
arm Group Labels
Gemcitabine, Paclitaxel, Carboplatin
name
gemcitabine
other Names
gemcitabine hydrochloride
type
DRUG
arm Group Labels
Gemcitabine, Paclitaxel, Carboplatin
name
paclitaxel
other Names
Taxol
type
DRUG
arm Group Labels
Gemcitabine, Paclitaxel, Carboplatin
name
surgery
type
PROCEDURE

Study design

allocation

intervention Model

SINGLE_GROUP

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 77
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Pathologic complete response (CR) is defined as absence of viable tumor in the TURBT specimen. Stable/No Response is defined as at least some disease evaluation tests were done (same tests as baseline) and status does not qualify for CR or Progression. Progression is defined as one or more of the following must occur: unequivocal progression of disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without documented progression or symptomatic deterioration.
measure
Pathologic Complete Response Rate by Transurethral Resection of Bladder Tumor (TURBT) and Imaging Studies After Chemotherapy
time Frame
up to 12 weeks after registration (assessed within 8 weeks after completion of 3 cycles of chemotherapy )

secondary Outcomes

description
Overall survival is defined from the date of registration to date of death from any cause
measure
Overall Survival (OS)
time Frame
0-2 years
description
Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal.
measure
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug
time Frame
Patients were assessed for adverse events at weeks 1, 2, 4, 5, 7, 8, and following surgery

Full study description

brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.
detailed Description: OBJECTIVES: * Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by observation or immediate cystectomy. * Determine, preliminarily, if molecular markers predict response, survival, and tumor recurrence in patients treated with these regimens. * Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy. * Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation. * Determine the feasibility, tolerability, and toxicity of these regimens in these patients. OUTLINE: This is a multicenter study. Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third transurethral resection of bladder tumor. Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation. These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until disease progression. Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy. Patients with T0 disease may also choose this option. Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years. PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.

Source references

references

citation
deVere White RW, Lara PN Jr, Goldman B, Tangen CM, Smith DC, Wood DP Jr, Hussain MH, Crawford ED. A sequential treatment approach to myoinvasive urothelial cancer: a phase II Southwest Oncology Group trial (S0219). J Urol. 2009 Jun;181(6):2476-80; discussion 2480-1. doi: 10.1016/j.juro.2009.01.115. Epub 2009 Apr 16.
pmid
19371909
type
RESULT
citation
Lara PN, Goldman B, De Vere White R, et al.: A sequential treatment approach to muscle-invasive urothelial cancer: A phase II Southwest Oncology Group trial (S0219) of neoadjuvant paclitaxel, carboplatin, and gemcitabine (PCG). [Abstract] J Clin Oncol 26 (Suppl 15): A-5022, 2008.
type
RESULT

Source notices and limitations

Discovery and provenance

release id
ctgov-registry-1336d216cbd1bbff780dac70
edge id
nct-edge-455cdaf7ef73e4c1902c
requested nct id
NCT00045630
primary nct id
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Urethral+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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id
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link basis
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nct id
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occurrences
context exact
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11
exact text
NCT00045630
start
0
offset unit
unicode_code_points
query cond
Urethral Cancer
query disease state id
ds-urethral-cancer
source file
/Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-urethral-cancer-000.json
source file sha256
308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
source json pointer
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source kind
ctgov_condition_query
source record id
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source string basis
parsed_JSON_string_unmodified
source string sha256
07baaf8cf243747114d90d198b2bcf1c60f713e82e8f6a51f9a8df7e93b5df91
source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Urethral+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true

Preserved source evidence · Not medical advice