Radiation Therapy Preparation for Pelvic Cancer

(BEFORE Trial)

Overseen By Tyler Seibert, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of California, San Diego

Disqualifiers: Pregnancy, Crohn's, Scleroderma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

Do I need to stop my current medications for this trial?

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.

What prior data suggests that these bladder protocols for pelvic radiation therapy are safe?

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. ^{1 2 3 4 5}

Why are researchers excited about this trial?

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.

What evidence suggests that these bladder protocols are effective for pelvic cancer?

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. ^{6 7 8 9 10}

Who Is on the Research Team?

Tyler Seibert, MD, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults over 18 with pelvic cancers (GU, Gyn, or GI) who can consent to the study and follow its procedures. They must be eligible for curative radiation therapy and agree to use effective contraception if they can become pregnant.

Inclusion Criteria

I am eligible for radiation therapy aimed at curing cancer in my pelvic area.

For participants able to become pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation

Provision of signed and dated informed consent form

Exclusion Criteria

Pregnancy

My tumor has spread to my bladder.

I cannot receive radiotherapy due to conditions like Crohn's, scleroderma, or uncontrolled lupus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

CT Simulation

Participants undergo a CT simulation to optimize radiation dose delivery

1 week

1 visit (in-person)

Radiation Therapy

Participants receive radiation therapy with either full or empty bladder protocols

6-8 weeks

Daily visits (in-person)

Follow-up

Participants are monitored for acute GU and GI toxicities post radiation therapy

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Pelvic Radiation Therapy

Trial Overview

The study is testing whether having a full or empty bladder during radiation therapy affects treatment outcomes for patients with pelvic cancers such as genitourinary, gynecological, or gastrointestinal malignancies.

How Is the Trial Designed?

Group I: Empty bladder Experimental Treatment 1 Intervention

Empty bladder protocol for participants undergoing radiation therapy to pelvis for common malignancies.

Group II: Full bladder Active Control 1 Intervention

Full bladder protocol for participants undergoing radiation therapy to pelvis for common malignancies.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 16 patients with late radiation tissue injury (LRTI) after pelvic radiation for gynaecological cancers, hyperbaric oxygen treatment (HBOT) did not show a significant effect on pain relief or daily function over a 6-month follow-up period.

Despite the lack of significant overall improvement, 50% of patients reported some positive effects from HBOT, suggesting that further research is needed to determine the optimal timing and patient selection for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy for late radiation tissue injury in gynaecological patients. Kongsgaard, A., Bjørgo, S., Kristensen, GB., et al.[2021]

Many female patients undergoing pelvic radiotherapy reported feeling unprepared for the sexual dysfunction side effects, leading to feelings of embarrassment and a negative impact on their self-esteem.

Effective communication from radiation oncologists about sexual side effects is crucial; patients expressed a desire for early discussions about sexual health to improve their care experience and maintain trust in their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative analysis of female patient perspectives on physician communication regarding sexual dysfunction associated with pelvic radiotherapy. Morgan, O., Schnur, J., Caban-Martinez, AJ., et al.[2023]

A study involving 107 cancer patients treated with pelvic radiation therapy found that 75% reported changes in sexual health due to their treatment, with 69% experiencing distress related to these changes.

Patients who had completed treatment reported greater distress and a higher interest in accessing a multidisciplinary sexual health clinic, highlighting the ongoing need for support in sexual health after radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical needs assessment for sexual health among cancer patients receiving pelvic radiation: Implications for development of a radiation oncology sexual health clinic. Wo, JY., Drapek, LC., Niemierko, A., et al.[2018]

Postoperative pelvic radiotherapy in uterine cancer patients led to a significant increase in daily bowel movements and a notable decrease in appetite, impacting overall quality of life.

Younger patients experienced more severe side effects, including increased pain, anxiety, and a greater reduction in daily activities compared to older patients, highlighting the need for tailored support during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical side effects and quality of life during postoperative radiotherapy for uterine cancer. Prospective evaluation by a diary card. Caffo, O., Amichetti, M., Mussari, S., et al.[2019]

Radiotherapy is crucial for treating pelvic cancers but can cause significant damage to normal tissues, leading to a condition known as pelvic radiation disease, which can be as difficult to manage as the cancer itself.

While acute symptoms from radiation injury typically resolve with medical treatment, chronic symptoms may necessitate surgery, which is complicated by the damaged tissue, highlighting the need for careful management of these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-Induced Problems in Colorectal Surgery. Ashburn, JH., Kalady, MF.[2020]

Intra-operative radiation therapy (IORT) can enhance local control of advanced pelvic malignancies, particularly when combined with surgical resection and external beam radiation, as shown in a review of 51 cases from Rush Medical College and the University of Navarre.

The study suggests that IORT is most effective when the tumor is partially resectable and when the total radiation dose exceeds 70 Gy, indicating a potential strategy for improving treatment outcomes in high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-operative radiation therapy in the treatment of pelvic malignancies: a preliminary report. Yordan, EL., Jurado, M., Kiel, K., et al.[2019]

In a study of 294 women with high-risk uterine-confined endometrial cancer, those who received adjuvant radiation therapy (RT) showed a 5-year disease-free survival rate of 86% and a pelvic control rate of 95%, indicating the efficacy of RT in preventing disease recurrence.

Factors such as unfavorable histology, older age, and capillary space invasion were linked to lower disease-free survival, suggesting that these characteristics should be considered when determining treatment strategies for patients at higher risk of recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which prognostic factors influence the outcome of patients with surgically staged endometrial cancer treated with adjuvant radiation? Greven, KM., Corn, BW., Case, D., et al.[2019]

A systematic review of four studies involving 89 participants found very low certainty of evidence that dietary fiber modifications significantly improve gastrointestinal side effects in patients undergoing pelvic radiotherapy for gynecologic cancers.

While some studies suggested potential benefits in reducing diarrhea and bowel symptoms, the overall evidence was insufficient to make specific dietary recommendations for clinical practice, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Dietary Fiber in Managing Gastrointestinal Toxicity Symptoms in Patients with Gynecologic Cancers undergoing Pelvic Radiotherapy: A Systematic Review. Croisier, E., Brown, T., Bauer, J.[2022]

In a study of 75 patients with low rectal cancers who underwent preoperative radiotherapy (PRT), the most common adverse events were leukocytopenia (12%) and diarrhea (24%), primarily classified as mild to moderate (grade 1-2).

Interestingly, patients who experienced these adverse events had a significantly better 5-year relapse-free survival rate (94% for those with leukocytopenia or diarrhea vs. 49% for those without), suggesting that these side effects may indicate a more favorable prognosis and should not deter the use of PRT in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic significance of adverse events associated with preoperative radiotherapy for rectal cancer. Ishihara, S., Watanabe, T., Akahane, T., et al.[2021]

In a study of 67 patients with endometrial cancer, those receiving proton beam therapy (PT) reported significantly less diarrhea during and after treatment compared to those receiving intensity-modulated radiation therapy (IMRT), suggesting PT may be a safer option for gastrointestinal side effects.

Patients treated with IMRT experienced higher rates of grade 3+ gastrointestinal toxicity, including loss of bowel control, indicating that PT could potentially lead to better patient-reported outcomes in terms of gastrointestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Proton Beam Therapy Compared With Intensity-Modulated Radiation Therapy for Uterine Cancer. Anderson, JD., Voss, MM., Laughlin, BS., et al.[2023]

In a study of 90 pelvic cancer patients, significant reductions in gastrointestinal (GI), sexual, and urinary symptoms were observed after treatment at a specialized rehabilitation clinic, with GI symptoms decreasing by 36.6%, sexual symptoms by 18.3%, and urinary symptoms by 15.5%.

Patients treated with bile salt sequestrants showed a notable improvement in GI symptoms, particularly diarrhea and fecal incontinence, with 91.3% experiencing a treatment effect, while local estrogens effectively reduced vaginal dryness and pain in 58.1% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Late adverse events in patients with pelvic cancer after oncologic treatment-intervention and treatment effect. Iselius, S., Knutsen, A., Mikiver, R., et al.[2023]

Patients referred for radiation enteritis after pelvic radiotherapy often experience significant nutritional deficiencies, with 91% having low hemoglobin and albumin levels, indicating a need for careful nutritional assessment and support.

All 11 patients in the study required surgical intervention due to radiation enteritis, with a median post-operative hospital stay of 24 days, highlighting the serious complications associated with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical experience with small bowel damage secondary to pelvic radiotherapy. Gidwani, AL., Gardiner, K., Clarke, J.[2021]

Radiation therapy has been shown to improve local control in rectal cancer patients, but it can also lead to significant side effects, making it important to identify which patients will benefit the most.

Current evidence suggests that some patients with less aggressive disease characteristics may not need radiation, but there is still a lack of randomized studies to confirm that these selected patients can safely avoid this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is radiation therapy required for patients with intermediate-risk rectal cancer? Mamon, H., Willett, CG.[2007]

Citations

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ascopubs.org

ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.4600

Survival outcomes of whole pelvic vs. bladder-only ...

Conclusions: This study found that in patients with MIBC, WP-RT was independently associated with better overall survival compared to BO-RT.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666168324002702

Risk of Secondary Malignancies After Pelvic Radiation

This study investigates the risk of secondary malignancy development following radiation for primary pelvic malignancies.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12022631/

Examining the role of elective pelvic radiotherapy in ...

Pelvic radiotherapy in node-negative prostate cancer remains controversial. Pelvic radiotherapy improves survival outcomes in very high-risk prostate cancer.

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ejgo.org

ejgo.org/DOIx.php?id=10.3802/jgo.2025.36.e65

The impact of bladder volume on dosimetric outcomes in ...

Maintaining an optimal bladder volume within the range of 300–500 mL could reduce the risk of radiation-induced cystitis and proctitis. Keywords.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT06037863

Evaluation of the Impact of Empty Versus Full Bladder in ...

This trial will evaluate the effects of an empty bladder vs. a full bladder prior to CT simulation and radiation therapy in patients with prostate cancer and ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12593702/

Outcomes of pelvic and para-aortic stereotactic ...

For cervix and uterine cancer patients, following SBRT reirradiation the median OS was 36.0 months (95 % CI 19.4 months to not reached) and 50.0 ...

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astro.org

astro.org/news-and-publications/news-and-media-center/news-releases/2025/radiation-therapy-after-surgery-safely-reduces-pelvic-relapse-risk-from-locally-advanced-mibc

Radiation therapy after surgery safely reduces pelvic ...

Two-year locoregional recurrence-free survival, the study's primary endpoint, was 91.2% with radiation therapy versus 76.4% without (p=0.004). “ ...

8.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.28849

Complications of pelvic radiation in patients treated for ...

Patients who receive pelvic radiation for gynecologic malignancies may experience a unique constellation of toxicity because of the anatomic locations.

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cancer.gov

cancer.gov/news-events/cancer-currents-blog/2020/patient-reported-side-effects-radiation-cervical-uterine-cancer

Women Experience More Side Effects than Clinicians ...

Women undergoing radiation therapy for cervical or uterine cancer have a much higher incidence of serious side effects than previously realized.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10979055/

Risk of Secondary Malignancies After Pelvic Radiation

This study investigates the risk of secondary malignancy development following radiation for primary pelvic malignancies.