Radical Cystectomy Compared With Chemoradiation for Muscle Invasive Bladder Cancer

NCT02716896 | Terminated Results DMC

• 2 other identifiers: HSC2015-620HUL1TR001120
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Currently the standard treatment of muscle invasive bladder cancer is the complete removal of bladder and adjacent organs, such as prostate or ovaries. Radical cystectomy is fraught with complications and risk of death. The researchers hope to learn if chemoradiation (i.e. using chemotherapy and radiation), also an acceptable treatment for muscle invasive bladder cancer, can be used a good alternative therapy option.

Conditions

Muscle Invasive Bladder Cancer

Keywords

cystectomy; radiation; chemotherapy

Outcome Measures

Primary Outcomes (3)

• Total Number of Participants Adhere to the Assigned Treatment

  Number of randomized participants that progressed to one year on treatment

  One year

• Total Number of Participants Withdraw From the Study

  Number of randomized participants who were withdrawn from the study by the investigator, or who voluntarily withdrew

  One year

• Total Number of Participants Completed the Study

  Number of randomized subjects who completed the study to one year

  One year

Secondary Outcomes (4)

• Change From Baseline and Year 1 in Health Related Quality of Life Measures

  One year

• Total Number of Participants Who Are Able to Keep Their Bladder Within the Time Frame of the Study

  One year

• Total Number of Participants Who Remained Progression-free Within the Time Frame of the Study

  One year

• Change From Baseline Level to Year 1 on Genomic Markers After Chemoradiation

  One year

Study Arms (2)

Surgery (radical cystectomy)

ACTIVE COMPARATOR

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, Glomerular Filtration rate (GFR), participant's preference, and availability of chemotherapeutic regimen.

Procedure: Radical cystectomy

Radiation and Chemoradiation

ACTIVE COMPARATOR

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: Radiation and chemoradiation

Interventions

Radiation and chemoradiation RADIATION

Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.

Also known as: Chemoradiation

Radiation and Chemoradiation

Radical cystectomy PROCEDURE

Radical cystectomy will be performed on those who are randomized to this group.

Also known as: Surgery

Surgery (radical cystectomy)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically) proven diagnosis of primary carcinoma of the bladder (transitional cell cancer) within 8 weeks of registration. Operable patients whose tumors are primary carcinomas of the bladder and exhibit histologic evidence of muscularis propria invasion and are AJCC clinical stages T2-T4a, Nx or N0, M0
• If radiologic evaluation of a lymph node is interpreted as "positive", this must be evaluated further either by lymphadenectomy or percutaneous needle biopsy. Patients with histologically or cytologically confirmed node metastases or any other metastases will not be eligible.
• Patients must have an adequately functioning bladder after thorough evaluation by an urologist and have undergone as thorough a transurethral resection of the bladder tumor as is judged safely possible.
• Patients must be considered able to tolerate systemic chemotherapy combined with pelvic radiation therapy, and a radical cystectomy by the joint agreement of the participating Urologist, Radiation Oncologist, and Medical Oncologist.
• History and physical examination including weight, performance status, and body surface area within 8 weeks prior to study registration
• Zubrod Performance Status 0-2
• Age ≥ 18;
• CBC (Complete blood count)/differential obtained no more than 4 weeks prior to registration on study, with adequate bone marrow function defined as follows:
• WBC (white bloodcell count) ≥ 4000/ml
• Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
• Platelets ≥ 100,000 cells/mm3;
• Hemoglobin ≥ 10.0 mg/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10.0 g/dl is acceptable.);
• Serum creatinine of 1.5 mg% or less; serum bilirubin of 2.0 mg% or less; creatinine clearance of 60 ml/min or greater no more than 4 weeks prior to registration; Note: Calculated creatinine clearance is permissible. If the creatinine clearance is \> 60 ml/min, then a serum creatinine of up to 1.8 mg% is allowable at the discretion of the principle investigator;
• Serum pregnancy test for female patients of childbearing potential, ≤ 72 hours prior to study entry; women of childbearing potential and male participants must practice adequate contraception.
• Patient must be able to provide study-specific informed consent prior to study entry

You may not qualify if:

• Unable and unwilling to provide informed consent
• Evidence of distant metastases or histologically or cytologically proven lymph node metastases
• Previous systemic chemotherapy (for any cancer) or pelvic radiation therapy
• A prior or concurrent malignancy of any other site or histology unless the patient has been disease-free for ≥ 5 years except for non-melanoma skin cancer and/or stage T1a prostate cancer or carcinoma in situ of the uterine cervix
• Patients judged not to be candidates for radical cystectomy; patients with pN (plasma nitrate)+ or T4b disease are considered to have unresectable disease
• Patients receiving any drugs that have potential nephrotoxicity or ototoxicity (such as an aminoglycoside)
• Severe, active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months;
• Transmural myocardial infarction within the last 6 months;
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration;
• Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration;
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol.
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note,however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Is pregnant; women of childbearing potential and male participants unwilling to practice adequate contraception.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78829, United States

Location

Related Links

• Screening logs from a pilot randomized controlled trial of radical vs chemoradiation therapy for muscle-invasive bladder cancer

MeSH Terms

Interventions

Radiation; Chemoradiotherapy; Cystectomy; Surgical Procedures, Operative

Intervention Hierarchy (Ancestors)

Physical Phenomena; Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Urologic Surgical Procedures; Urogenital Surgical Procedures

Results Point of Contact

• Title: Dharam Kaushik
• Organization: University of Texas Health San Antonio

kaushik@uthscsa.edu

210-567-5676

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: March 23, 2016
• Study Start: May 1, 2016
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: November 25, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-11

Locations

US (1)