Radiation Therapy Preparation for Pelvic Cancer

(BEFORE Trial)

This trial tests two preparation methods for pelvic radiation therapy for cancers in the pelvic area. One group receives treatment with an empty bladder, while the other has a full bladder during therapy. Researchers aim to determine which method is more effective for treating cancers affecting the urinary, reproductive, or digestive systems. Eligible participants are those who can undergo radiation therapy intended to cure pelvic cancers. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking advancements in cancer treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research has shown that pelvic radiation therapy can be effective but may also cause side effects. It lowers the chance of cancer returning in the pelvic area after surgery. However, patients, especially women, have reported more side effects than initially expected. These side effects can be serious because the treatment affects nearby organs. In some cases, there is a risk of developing new cancers in the treated area later on. While pelvic radiation therapy is generally considered safe, participants should discuss potential risks with their healthcare provider.¹²³⁴⁵

Researchers are excited about this trial because it explores whether bladder fullness can influence the effectiveness of radiation therapy for pelvic cancer. While standard radiation therapy typically focuses on precise targeting and dosage, this trial investigates how the bladder's state can impact treatment outcomes. By comparing empty versus full bladder protocols, researchers aim to identify the optimal conditions for delivering radiation, potentially enhancing efficacy and minimizing side effects. This innovative approach could lead to more personalized and effective treatment strategies for pelvic cancer patients.

Research has shown that pelvic radiation therapy can extend life in certain cancers, particularly very high-risk prostate cancer. This trial will compare two approaches: an empty bladder protocol and a full bladder protocol for participants undergoing pelvic radiation therapy. Studies suggest that maintaining the bladder at an ideal size (300–500 mL) during treatment might reduce side effects such as bladder or bowel irritation. Evidence also indicates that targeting radiation at the entire pelvic area can improve survival more than focusing solely on the bladder in some cases. Thus, managing bladder size during radiation could enhance treatment effectiveness and reduce risks.⁶⁷⁸⁹¹⁰