Health TrialsbyHealthPanel

Adaptive Radiotherapy for Genitourinary Cancers

ConditionsProstate Cancer (Post Prostatectomy)Bladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with newly diagnosed or metastatic/recurrent pathologically confirmed urological tumors, clinically assessed as suitable for adaptive radiotherapy;

Age ≥ 18 years;

ECOG performance status score 0-2;

No prior radiotherapy history within the current radiation field;

Disqualifiers

Patients with contraindications to radiotherapy;

Patients unable to tolerate MRI or with contraindications to MRI scanning.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Acute GU and GI toxicities as per NCI-CTC 5.0 criteria 3-months post RT

Time frame
3-months post-RT

Secondary outcomes

1

Quality-of-Life, general

general quality-of-life questionaaires as per EORTC QLQ-C30

Time frame
Baseline, 1-month post-RT, every 3 months till 2-years post-RT
2

Local control

local control

Time frame
2-year
3

disease-free survival

disease-free survival

Time frame
2-year
4

Late toxicities

Late GU and GI toxicities as per RTOG scales

Time frame
2-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now