Trial comparing treatments for Muscle Invasive Bladder Urothelial Carcinoma
Official title Testing Shorter Duration Radiation Therapy Versus the Usual Radiation Therapy in Patients Receiving the Usual Chemotherapy Treatment for Bladder Cancer, ARCHER Study
ClinicalTrials.gov ID: NCT07097142
What this study is testing
What is Cisplatin?
Cisplatin is an investigational chemotherapy drug being studied for muscle invasive bladder urothelial carcinoma. Cisplatin is designed to bind to DNA in tumor cells and interfere with DNA replication, which can stop cancer cells from growing.
Also referred to as Abiplatin, Blastolem, Briplatin, CDDP, Cis-diammine-dichloroplatinum, Cis-diamminedichloridoplatinum, Cis-diamminedichloro Platinum (II), Cis-dichloroammine Platinum (II), Cis-platinous Diamine Dichloride, Cis-platinum, Cis-platinum II, Cis-platinum II Diamine Dichloride, Cismaplat, Cisplatina, Cisplatinum, Cisplatyl, Citoplatino, Citosin, Cysplatyna, DDP, Lederplatin, Metaplatin, Neoplatin, Peyrone's Chloride, Peyrone's Salt, Placis, Plastistil, Platamine, Platiblastin, Platiblastin-S, Platinex, Platinol, Platinol-AQ, Platinol-AQ VHA Plus, Platinoxan, Platinum, Platinum Diamminodichloride, Platiran, Platistin, Platosin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out whether ultra‑hypofractionated radiation (fewer sessions) works as well as standard hypofractionated radiation when given with standard chemotherapy for muscle‑invasive bladder cancer.
- Who it's for
- Adults with stage II or IIIA muscle‑invasive bladder cancer who are receiving standard chemotherapy.
- What's involved
- Participants will get standard chemotherapy (cisplatin, gemcitabine, or mitomycin‑C with 5‑fluorouracil) and either a shorter radiation schedule or the usual longer radiation schedule, plus required clinic visits and tests.
- Time commitment
- Treatment lasts a few weeks with multiple radiation sessions and clinic visits throughout the study period.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.
- Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible
- Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization.
- Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without...
- If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT / MRI of abdomen and pelvis), then the patient must have...
See the full eligibility criteria
- Histologically proven, cT2-T3,N0M0 urothelial carcinoma of the bladder prior to randomization.
- Note: Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible
- Must undergo a transurethral resection of bladder tumor (TURBT) prior to randomization. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection
- Must undergo radiological staging prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI (with or without contrast is acceptable).
- If any lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter are noted on imaging (CT / MRI of abdomen and pelvis), then the patient must have had a biopsy of the enlarged lymph node showing no tumor involvement...
- No diffuse carcinoma in situ (CIS) based on cystoscopy and biopsy
- No definitive clinical or radiologic evidence of metastatic disease
- Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/Carcinoma in situ (CIS) of the upper urinary tract including...
- Age ≥ 18
- Zubrod performance status of ≤ 2
- Not pregnant and not nursing
- Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration.
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb]) ≥ 8.0 g/dl is acceptable)
- Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN
- All adverse events associated with any prior therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 3 prior to randomization
- For patients who have completed ≥3 cycles of neoadjuvant chemotherapy prior to randomization, this eligibility window from diagnosis (TURBT Path) to enrollment is extended to 240 days before randomization.
- Must not have had prior pelvic radiation
- New York Heart Association Functional Classification II or better (NYHA Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of...
- No active infection requiring IV antibiotics
- Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meet criteria specified
The study team makes the final eligibility decision.
Where it is enrolling
- Fairbanks, Alaska, United States
- Fort Smith, Arkansas, United States
- Little Rock, Arkansas, United States
- Beverly Hills, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Sacramento, California, United States
- Tarzana, California, United States
- Torrance, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Highlands Ranch, Colorado, United States
- Littleton, Colorado, United States
- Lone Tree, Colorado, United States
- Parker, Colorado, United States
- Lewes, Delaware, United States
- Millville, Delaware, United States
- Newark, Delaware, United States
+ 174 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fairbanks, Alaska, United States; Fort Smith, Arkansas, United States; Little Rock, Arkansas, United States; Beverly Hills, California, United States; Irvine, California, United States; La Jolla, California, United States and 188 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.