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The goal of this clinical trial is to learn if adaptive radiation boost works to treat genitourinary cancers, esp. in the context of prostate cancer patients with post-prostatectomy local relapse and bladder cancer patients with bladder-conserving treatment. It will also learn about the safety and efficacy of adaptive boost. The main questions it aims to answer are:
Does adaptive boost lower the toxicities? Does adaptive boost maintain or improve the clinical efficacy?
Participants will:
Undergo adaptive boost on 1.5-Tesla MR-Linac Visit the clinic once every 2 weeks during RT, and every 3 months post-ART Keep a regular QOL questinnaire completion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental arm | Experimental | Pts will receive adaptive boost for clinically significant disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adaptive RT | Radiation | Prostate cancer pts post-prostatectomy:95%PTVboost 7Gy/3.5Gy/2f,95%PTV 66Gy/2.0Gy/33f,w/o 95%PTVp 50Gy/2.0Gy/25f Bladder cancer pts with bladder-conserving txt:95%PGTV 18Gy/6.0Gy/3f,95%PTV 50Gy/2.0Gy/25f,w/o 95%PTVp 50Gy/2.0Gy/25f |
| Measure | Description | Time Frame |
|---|---|---|
| Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT | 3-months post-RT |
| Measure | Description | Time Frame |
|---|---|---|
| Quality-of-Life, general | general quality-of-life questionaaires as per EORTC QLQ-C30 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Local control | local control |
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Inclusion Criteria:
Exclusion Criteria:
Male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning-Ning Lu, M.D. | Contact | 861018611804268 | ningninglu09@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital, National Cancer Center, CAMS & PUMC | Recruiting | Beijing | Beijing Municipality | 100021 | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 2-year |
| disease-free survival | disease-free survival | 2-year |
| Late toxicities | Late GU and GI toxicities as per RTOG scales | 2-year |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | GU quality-of-life questionaaires as per EORTC QLQ-NMIBC24 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per EORTC QLQ- BLM30 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per BCI | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per FACT-BL | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per FACT-P | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Quality-of-Life, GU (genitourinary) and GI (gastrointestinal) scales | quality-of-life questionaaires as per EPIC-26 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| Quality-of-Life, sexual scales | quality-of-life questionaaires as per IIEF-5 | Baseline, 1-month post-RT, every 3 months till 2-years post-RT |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D014571 | Urologic Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |