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Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer

Primary Purpose

Bladder Cancer

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Surgery of percutaneous catheter system

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Effects of Chemotherapy, intraarterial chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy.
Transitional cell carcinoma of bladder, stage pT3-4,N1-3,M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.
Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.
ECOG performance status 0 or 1.
Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN).Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).
Absolute neutrophil count (ANC) ≥ 1500/μL
Platelets ≥ 75,000/μL
Hemoglobin ≥ 8.0 g/dL
White blood cell count ≥ 3500/μL
Creatinine clearance rate,Ccr ≥ 40ml/min
Cardiac function level 0~2.
Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures.

Exclusion Criteria:

Bladder cancer without any transitional cell carcinoma component,such as adenocarcinoma,squamous cell carcinoma,small cell carcinoma
Evidence of distant metastasis beyond the pelvis.
No definitely pathological stage,such as no pathologic examination of perivesical fat,unable to differentiate pT2 and pT3,not performing lymph node dissection or regional lymph nodes cannot be assessed as the dissected lymph node number is less than ten.
Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months preoperatively, not including intra-vesical infusion chemotherapy.
Prior pelvic radiation therapy dosage ≥ 30Gy six months preoperatively.
Serious liver and kidney dysfunction.
Accompanied with other serious diseases.
Severe/unstable angina, arrhythmia,symptomatic heart failure, hypertension that cannot be controlled by medications and 6 months for myocardial infarction.
Non-compliance of regular follow-up due to psychological, social, family and geographical and other reasons.

Sites / Locations

Cancer Center, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intraaterial chemotherapy

Watchful waiting

Arm Description

This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study.Patients with locally advanced TCC of the bladder are randomized to 1 of 2 treatment arms Arm 1 (treatment):'Surgery of percutaneous catheter system for arterial chemotherapy is done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique.Gemcitabine 800 mg/m2 intra-arterial,cisplatin 25 mg/m2 intra-arterial once a week for 3 weeks followed by 1-week rest period. Maximum of 3 cycles. Treatment begins between 1-5 weeks after radical operation (within 40 days is recommended).

Arm 2 (control): No immediate post-surgery treatment. Patients undergo observation followed by cisplatin and gemcitabine as in arm I at local relapse, or receive intravenously chemotherapy with cisplatin and gemcitabine at multiple metastases

Outcomes

Primary Outcome Measures

cancer progressive free survival rate

Secondary Outcome Measures

overall survival

Cancer specific survival

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

NCT ID

NCT01627197

First Posted

June 13, 2012

Last Updated

October 13, 2017

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01627197

Brief Title

Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer

Official Title

Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 2012 (undefined)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients cystectomized for locally advanced bladder cancer.

Detailed Description

For locally advanced bladder cancer patients, tumor relapse rates after radial cystectomy were even as high as 50%-62%.Five-year disease-specific survival and OS rates in the organ-confined disease (defined as ≤pT3a) were 78.9% and 68%, respectively. For the non-organ-confined disease (defined as pT3b or higher), the rates were about 36.8% and 30.3%, respectively.Systemic chemotherapy can only prolong survival for up to 14.8 months, although with multiple severe adverse effects, such as neutrocytopenia, infection/sepsis, renal dysfunction, mucositis, or gastrointestinal toxicity. Additionally, the mortality rate associated with systemic chemotherapy was about 1%-4%.Therefore, the objective of our study was to determine if adjuvant intra-arterial chemotherapy with GC was able to reduce the systemic drug toxicities and yield a better clinical outcome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bladder Cancer

Keywords

Effects of Chemotherapy, intraarterial chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

212 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intraaterial chemotherapy

Arm Type

Active Comparator

Arm Description

Arm Title

Watchful waiting

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Surgery of percutaneous catheter system

Intervention Description

Intraarterial (IA) catheterization was done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique. An angiographic catheter was inserted through the femoral artery into the internal iliac artery. The catheter tips were located superior to the origin of bilateral common artery.

Primary Outcome Measure Information:

Title

cancer progressive free survival rate

Time Frame

60 months

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

60 months

Title

Cancer specific survival

Time Frame

60 months

Title

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy. Transitional cell carcinoma of bladder, stage pT3-4,N1-3,M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components. Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months. ECOG performance status 0 or 1. Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x upper limit of normal (ULN).Total serum bilirubin≤ 1.5 x upper limit of normal (ULN). Absolute neutrophil count (ANC) ≥ 1500/μL Platelets ≥ 75,000/μL Hemoglobin ≥ 8.0 g/dL White blood cell count ≥ 3500/μL Creatinine clearance rate,Ccr ≥ 40ml/min Cardiac function level 0~2. Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests,and other study procedures. Exclusion Criteria: Bladder cancer without any transitional cell carcinoma component,such as adenocarcinoma,squamous cell carcinoma,small cell carcinoma Evidence of distant metastasis beyond the pelvis. No definitely pathological stage,such as no pathologic examination of perivesical fat,unable to differentiate pT2 and pT3,not performing lymph node dissection or regional lymph nodes cannot be assessed as the dissected lymph node number is less than ten. Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months preoperatively, not including intra-vesical infusion chemotherapy. Prior pelvic radiation therapy dosage ≥ 30Gy six months preoperatively. Serious liver and kidney dysfunction. Accompanied with other serious diseases. Severe/unstable angina, arrhythmia,symptomatic heart failure, hypertension that cannot be controlled by medications and 6 months for myocardial infarction. Non-compliance of regular follow-up due to psychological, social, family and geographical and other reasons.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fang-Jian Zhou, M.D Ph.D

Phone

+86(20)13922735659

zhoufj@sysucc.org.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Zhuo-Wei Liu, M.D Ph.D

Phone

+86(20)13610138571

liuzhw@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fang-Jian Zhou, M.D Ph.D

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center, Sun Yat-sen University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang-Jian Zhou, M.D Ph.D

zhoufj@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Zhuo-wei Liu

liuzhw@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Fang-Jian Zhou, M.D Ph.D

First Name & Middle Initial & Last Name & Degree

Zhuo-Wei Liu, M.D Ph.D

12. IPD Sharing Statement

Plan to Share IPD

Yes

Learn more about this trial

Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer

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