Shorter Duration Radiation Therapy for Bladder Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase III trial compares the effect of decreased number of radiation (ultra-hypofractionated) treatments to the usual radiation number of treatments (hypofractionation) with standard of care chemotherapy, with cisplatin, gemcitabine or mitomycin and 5-fluorouracil for the treatment of patients with muscle invasive bladder cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a short period of time. Ultra-hypofractionated radiation therapy delivers radiation over an even shorter period of time than hypofractionated radiation therapy. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Chemotherapy drugs, such as mitomycin-C and 5-fluorouracil (5-FU), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ultra-hypofractionated radiation may be equally effective as hypofractionated therapy for patients with muscle invasive bladder cancer.
Who Is on the Research Team?
Scott E Delacroix
Principal Investigator
NRG Oncology
Are You a Good Fit for This Trial?
This trial is for adults with muscle invasive bladder cancer that hasn't spread beyond the bladder or lymph nodes. Participants must have had a biopsy confirming no tumor in enlarged lymph nodes and a maximal resection attempt of the tumor. They should not have other urothelial cancers outside the bladder within 24 months, except specific cases treated with nephroureterectomy.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Cisplatin
- Fluorouracil
- Gemcitabine
- Mitomycin
- Ultrahypofractionated Radiation Therapy
Trial Overview
The ARCHER study is comparing two radiation therapy schedules alongside standard chemotherapy for treating bladder cancer: ultra-hypofractionated (fewer, higher-dose treatments) versus hypofractionated (standard number of high-dose treatments). It also involves various diagnostic procedures like MRI and CT scans.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients receive ultra-hypofractionated RT QD, no more than twice weekly, for 5 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up.
Patients receive hypofractionated RT QD, Monday to Friday, for 20 treatments in the absence of disease progression or unacceptable toxicity. Patients also receive one of 3 systemic chemotherapy regimens per treating physician's choice: 1) cisplatin IV weekly for 4 weeks; 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22 and 25 or weekly for 4 weeks; or 3) mitomycin-C IV on day 1 and 5 FU, over 120 hours on days 1-5 and 22-26. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan and/or MRI or FDG PET throughout the study. In addition, patients may undergo optional blood and urine sample collection throughout the study, as well as an optional biopsy during cystoscopy during follow up.
Find a Clinic Near You
Who Is Running the Clinical Trial?
NRG Oncology
Lead Sponsor
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