Radiation Therapy for Gastrointestinal Cancer

Recruiting at 1 trial location

Overseen By Hewitt Chang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Immunotherapy

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Radiation therapy, Immunotherapy trial, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 19

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of radiation therapy in treating gastrointestinal cancer that has spread. The researchers aim to determine if adding radiation to ongoing immunotherapy can slow or stop cancer growth and potentially boost the immune system to fight tumors not directly targeted by the radiation. The trial seeks participants whose gastrointestinal cancer is worsening despite immunotherapy and who have one to five areas needing radiation treatment due to symptoms like pain, bleeding, or other risks. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future cancer treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you may need to stop them as they could affect the immunotherapy.

What prior data suggests that radiation therapy is safe for treating metastatic gastrointestinal cancer?

Research has shown that radiation therapy is generally safe for treating various types of cancer, even when the cancer has metastasized. Studies have found that radiation therapy is effective and safe for treating metastatic cancers. For instance, patients have tolerated standard radiation treatments well, even those with multiple areas of cancer spread.

Some side effects may occur, particularly those affecting the stomach and intestines, but these are often similar to those seen with other radiation treatments. Overall, radiation therapy is usually manageable, and serious side effects are rare.

The treatment involves precisely targeting the cancer with a specific dose of radiation, which helps protect the surrounding healthy tissue. This precision is crucial for reducing potential negative effects. While some risks exist, research generally considers the treatment safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for gastrointestinal cancer, which often involve extended cycles of chemotherapy or surgery, this radiation therapy approach is exciting because it offers a potentially quicker and more targeted option. Patients receive a total of five treatments over just 5–9 days, delivering a precise 30 Gy dose to up to five treatment sites. This method aims to reduce the overall treatment time and minimize side effects while maintaining effectiveness, making it a promising option for those who may not tolerate longer, more invasive therapies well. Researchers are hopeful that this concentrated approach could lead to faster results and improved patient outcomes.

What evidence suggests that radiation therapy is effective for metastatic gastrointestinal cancer?

Research shows that radiation therapy, which participants in this trial will receive, effectively treats gastrointestinal cancer. Studies indicate that stereotactic body radiation therapy (SBRT) is usually well-tolerated and works as well as other types, such as intensity-modulated radiotherapy (IMRT). SBRT can effectively target and shrink tumors, which is crucial for cancers that have spread. Some studies suggest that radiation therapy might also help the immune system fight cancer cells in other parts of the body, not just where the radiation is aimed. Overall, radiation therapy is a promising option for controlling tumor growth and may enhance the effects of immunotherapy. ^{1 2 6 7 8}

Who Is on the Research Team?

Mary Feng, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults with metastatic gastrointestinal cancers, including esophageal and colorectal cancers, among others. Participants must have at least two progressing metastases, be on immunotherapy with worsening disease, and have a life expectancy over 6 months. They should not be pregnant or become pregnant during the trial and must use contraception.

Inclusion Criteria

I am mostly self-sufficient and can carry out daily activities.

I have seen a radiation oncologist within the last 28 days.

I have at least two growing cancer spots, and one can be left untreated safely.

Exclusion Criteria

I am not on strong immune system-suppressing drugs that would affect immunotherapy.

My doctor has determined that radiation therapy is not safe for me.

I am in a clinical trial for immunotherapy where radiation is not allowed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity.

1-2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 36 months

Visits at 14 days, 6 months, and then up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy

Trial Overview The study tests if radiation therapy can slow down or stop the growth of spreading gastrointestinal tumors in patients already receiving immunotherapy. It also explores whether radiating one tumor might activate the immune system to fight other non-radiated tumors.

How Is the Trial Designed?

Group I: Radiation therapy (RT) Experimental Treatment 1 Intervention

Patients undergo radiation therapy for a total of 5 treatments over 5-9 calendar days in the absence of disease progression or unacceptable toxicity. Target prescription dose will be 30 Gy in 5 fractions and each treatment site (up to 5) will undergo standard Department-approved treatment planning, quality-assurance, and delivery protocols

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Varian Medical Systems

Industry Sponsor

Trials

63

Recruited

3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

Intraoperative radiotherapy (IORT) is a feasible addition to the treatment of gastrointestinal cancer, achieving over 90% local control of tumors, whether they are primary or recurrent.

The use of electron beam IORT does not interfere with surgical procedures or systemic therapies, making it a safe and effective option in multimodal cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative radiotherapy for gastrointestinal malignancies: contemporary outcomes with multimodality therapy. Calvo, FA., Sole, CV., Marsiglia, H., et al.[2018]

Intensity-modulated radiation therapy (IMRT) is designed to reduce both acute and late toxicities associated with traditional radiation therapy for gastrointestinal tumors, showing promise in sparing healthy organs while effectively targeting tumors.

Preclinical studies indicate that IMRT maintains adequate coverage of tumor targets while minimizing damage to surrounding tissues, but further clinical research is needed to fully establish its role in GI tumor management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiation therapy for gastrointestinal tumors. Meyer, JJ., Czito, BG., Willett, CG.[2021]

Surgery remains the primary treatment for most gastrointestinal cancers, but radiotherapy is increasingly used alongside surgery to enhance local control and improve survival rates.

The abstract discusses the evolving role of radiotherapy in treating gastrointestinal malignancies, including new techniques that are being investigated to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of radiotherapy in the surgical management of gastrointestinal cancer. Mahadevan, A., Carey, D.[2019]

Intensity-modulated radiation therapy (IMRT) allows for precise targeting of cancerous tissues while minimizing damage to surrounding healthy tissues, making it a significant advancement over traditional 3D-conformal radiation therapy.

Early clinical experiences with IMRT in treating gastrointestinal cancers, such as gastric and pancreatic cancers, suggest lower normal tissue toxicities, supporting its efficacy and safety in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of intensity-modulated radiation therapy in gastrointestinal cancer. Bockbrader, M., Kim, E.[2022]

The phase II RTCMIENDOMETRE trial demonstrated that post-operative intensity-modulated radiation therapy (IMRT) significantly reduced the incidence of acute gastrointestinal (GI) toxicity to 27%, which is below the targeted threshold of 30% for grade 2 or higher adverse events in patients with endometrial cancer.

At the 15-week follow-up, no patients experienced grade 2 or higher GI toxicity, and the prevalence of remaining grade 1 events was less than 20%, indicating that IMRT is a safer option compared to conventional pelvic irradiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of post operative intensity modulated radiotherapy on acute gastro-intestinal toxicity for patients with endometrial cancer: results of the phase II RTCMIENDOMETRE French multicentre trial. Barillot, I., Tavernier, E., Peignaux, K., et al.[2022]

Recent advancements in intradiation techniques have expanded the use of radiation therapy for gastrointestinal cancers, showing benefits in both preoperative and postoperative settings for rectal and rectosigmoid carcinoma.

High-dose external beam irradiation, with or without chemotherapy, has shown promising results for locally advanced pancreatic and gastric cancers, while radiotherapy has also provided long-term control in selected esophageal cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of radiation therapy in gastrointestinal cancer. Weissberg, JB.[2019]

Intraoperative radiation therapy (IORT) provides a way to deliver higher doses of radiation directly to tumors or high-risk areas during surgery, which can improve local control of gastrointestinal cancers.

This method minimizes damage to surrounding healthy tissues, making it a promising option for patients with unresectable tumors or those at high risk for local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Radiation Therapy for Gastrointestinal Malignancies. Ritter, AR., Miller, ED.[2023]

In a study of 100 prostate cancer patients treated with high-dose intensity-modulated radiotherapy (IMRT) and image-guided treatment (IGRT), acute gastrointestinal (GI) toxicity was observed in 12% and genitourinary (GU) toxicity in 42%, with only 4% experiencing severe GU toxicity (grade 3).

After a median follow-up of 26 months, late toxicity rates were low, with only 1.5% experiencing late GI toxicity and 7.7% experiencing late GU toxicity, indicating that high-dose radiotherapy is both effective and has manageable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity after intensity-modulated, image-guided radiotherapy for prostate cancer. Guckenberger, M., Ok, S., Polat, B., et al.[2022]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

Prostate cancer patients receiving image-guided radiotherapy (IGRT) experienced significantly less severe acute toxicity, such as urinary frequency, diarrhoea, and fatigue, compared to those who did not receive IGRT, with 23% vs 7% for urinary frequency ≥G3 and 15% vs 3% for diarrhoea ≥G2.

The onset of these toxicities was earlier in the non-IGRT group, indicating that IGRT not only reduces the severity of symptoms but also delays their onset, leading to a more tolerable treatment experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. Gill, S., Thomas, J., Fox, C., et al.[2021]

Intensity-modulated radiotherapy (IMRT) significantly improves quality of life (QoL) for patients with head and neck cancers compared to traditional two-dimensional radiotherapy (2DRT) and three-dimensional conformal radiotherapy (3DCRT), particularly in areas like dry mouth and eating-related difficulties.

The review included 14 studies, highlighting that while IMRT shows promise for enhancing QoL, further prospective randomized studies are needed to confirm its benefits and justify the additional resources required for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy versus conventional and 3D conformal radiotherapy in patients with head and neck cancer: is there a worthwhile quality of life gain? Tribius, S., Bergelt, C.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3986382/

Stereotactic Body Radiation Therapy Versus Intensity ... Although SBRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT.

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.713

Toxicity and efficacy of stereotactic body radiation therapy ... When compared to IMRT, SBRT demonstrates improved tolerability for treatment of patients with LAPC with comparable clinical efficacy.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1470204522005174

Intensity-modulated radiotherapy versus stereotactic body ... Overall, this study shows similar gastrointestinal toxicity with ultra-hypofractionation compared with standard fractionation. Genitourinary ...

4. renovorx.com renovorx.com/wp-content/uploads/2023/01/ASCO-GI_Radiation-Poster_KAG.pdf

Toxicity and efficacy of stereotactic body radiation therapy ... Herein, we use clinical data to compare toxicity and efficacy between SBRT and IMRT. BACKGROUND. LAPC patients with a 0-1 ECOG and diagnosis within 6 weeks ...

5. nature.com nature.com/articles/s41598-025-06707-1

Dosimetric comparison of IMRT, VMAT, and hybrid ... This study compares three distinct SBRT techniques: pure intensity-modulated radiotherapy (IMRT), pure volumetric modulated arc therapy (VMAT), and a hybrid ...

6. nrgoncology.org nrgoncology.org/Home/News/Post/nrg-oncology-trial-results-show-favorable-bowel-health-related-quality-of-life-outcomes-for-localized-immediate-risk-prostate-cancer-treated-with-stereotactic-body-radiation-therapy

NRG Oncology Trial Results Show Favorable Bowel Health ... Results of the NRG Oncology NRG-GU005 clinical study comparing stereotactic body radiation therapy (SBRT) to moderately hypofractionated ...

7. ascopubs.org ascopubs.org/doi/10.1200/GO-25-00004

Metastasis-Directed Stereotactic Body Radiation Therapy ... SBRT is effective and safe for treating OM and OP solid cancers, prolonging FISST and potentially delaying systemic treatments, particularly in ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2778658

Evaluation of Safety of Stereotactic Body Radiotherapy for ... Standard ablative radiation schedules appear to be safe for patients with oligometastatic disease with 3 to 4 metastases or 2 metastases in close proximity to ...