Radiation Therapy for Carcinoid Tumors

Not yet recruiting at 1 trial location

Overseen By Pretesh Patel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Emory University

Disqualifiers: Prior radiation, Brain metastases, others

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

Compensation: Varies

Number of Visits: 10

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to treat hard-to-remove neuroendocrine tumors in the digestive system. It combines two treatments: precise radiation therapy (Stereotactic Body Radiation Therapy) and a radioactive drug that targets tumor cells (Lutetium Lu 177 Dotatate). The researchers aim to determine if adding radiation therapy before the drug enhances safety and effectiveness compared to the drug alone. This trial may suit individuals with large neuroendocrine tumors that have not responded well to one or two prior treatments and cannot be surgically removed. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

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 this combination of SBRT and 177Lu-DOTATATE is safe for treating neuroendocrine tumors?

Research has shown that both treatments in this trial have been studied for safety in humans.

Lutetium Lu 177 Dotatate is already used for certain neuroendocrine tumors and has been administered to over 1,200 patients in various studies. It is generally well-tolerated, though some people have experienced side effects like nausea and tiredness. Research found it remained safe even when patients received it again after their disease worsened.

Stereotactic Body Radiation Therapy (SBRT) is also known to be safe. It targets tumors precisely, which helps protect healthy tissue. Studies have shown it is a good option for patients with certain lung tumors, offering effective treatment with manageable side effects.

Overall, while both treatments have been shown to be safe in other studies, this trial will help confirm their safety when used together. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine two innovative approaches for treating carcinoid tumors. Lutetium Lu 177 Dotatate is a radiolabeled therapy that specifically targets tumor cells by binding to somatostatin receptors, delivering radiation directly to the cancer and sparing surrounding healthy tissue. Stereotactic Body Radiation Therapy (SBRT), on the other hand, is a precise form of radiation that delivers high doses directly to the tumor with minimal impact on nearby organs. This combination aims to enhance effectiveness by maximizing tumor destruction while minimizing side effects, potentially offering a more targeted and efficient alternative to traditional treatments like surgery and conventional radiation therapy.

What evidence suggests that this trial's treatments could be effective for neuroendocrine tumors?

In this trial, participants will receive a combination of Lutetium Lu 177 Dotatate (177Lu-DOTATATE) and Stereotactic Body Radiation Therapy (SBRT). Studies have shown that 177Lu-DOTATATE effectively treats neuroendocrine tumors by extending the time patients live without tumor progression. It targets specific parts of tumor cells and delivers radiation directly to them. Meanwhile, SBRT shows promise by focusing high doses of radiation precisely on tumors while sparing healthy tissue. Research indicates that SBRT effectively stops tumors from growing in the treated area. Together, these treatments may offer a better chance of controlling tumors that cannot be removed by surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Pretesh Patel, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for patients with large, well-differentiated grade 1-2 gastrointestinal neuroendocrine tumors that can't be surgically removed. Details about specific inclusion and exclusion criteria are not provided, but typically participants would need to meet certain health standards and may be excluded based on factors like other medical conditions or treatments.

Inclusion Criteria

I am either male or female.

I am 18 years old or older.

Patient must be able to provide study specific informed consent

Exclusion Criteria

I have had radiation therapy to the same area before.

I cannot have radiation therapy due to conditions like inflammatory bowel disease.

My cancer has spread to my brain or spinal canal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo stereotactic body radiation therapy (SBRT) over 5 fractions

1 week

5 visits (in-person)

Treatment

Participants receive 177Lu-DOTATATE intravenously once every 8 weeks for 4 doses

32 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

1 visit every 3 months (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lutetium Lu 177 Dotatate
• Stereotactic Body Radiation Therapy

Trial Overview The trial tests the combination of stereotactic body radiation therapy (SBRT) followed by a radioactive drug called 177Lu-DOTATATE in patients with certain neuroendocrine tumors. SBRT precisely targets tumor cells while sparing normal tissue, and 177Lu-DOTATATE binds to tumor cells to deliver radiation directly.

How Is the Trial Designed?

Group I: Treatment (SBRT, 177Lu-DOTATATE) Experimental Treatment 7 Interventions

Patients undergo SBRT over 5 fractions in the absence of disease progression or unacceptable toxicity. Starting 4-10 weeks after completion of SBRT, patients receive SOC 177Lu-DOTATATE IV once every 8 weeks for 4 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the trial and undergo gallium Ga 68-DOTATATE PET/CT before treatment.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK587368/

Neuroendocrine Tumor 177Lutetium-Dotatate Therapy - NCBI Clinical trials, including the landmark NETTER-1 study, have demonstrated significant improvements in progression-free survival, quality of life ...

2. onclive.com onclive.com/view/lutetium-lu-177-dotatate-yields-partial-responses-in-metastatic-bronchopulmonary-neuroendocrine-tumors

Lutetium Lu 177 Dotatate Yields Partial Responses in ... Lutetium Lu 177 dotatate demonstrated antitumor activity in metastatic BP-NETs, with partial responses in 17% of patients and stable disease in ...

3. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1393317/full

Long-term clinical outcomes of [ 177 Lu]Lu-DOTATATE in ... The most frequently reported (>15%) nonhematologic treatment-related adverse events were fatigue, nausea, vomiting, and diarrhea. Clinically ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04665739

NCT04665739 | Testing Lutetium Lu 177 Dotatate in ... Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors. Detailed Description.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1607427

Phase 3 Trial of 177 Lu-Dotatate for Midgut ... Treatment with 177 Lu-Dotatate resulted in markedly longer progression-free survival and a significantly higher response rate than high-dose octreotide LAR.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/208700s031lbl.pdf

LUTATHERA® (lutetium Lu 177 dotatate) injection, for ... Safety data are available from 1214 patients in ERASMUS, an international ... label study in 20 patients with somatostatin receptor-positive midgut carcinoid ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40310018/

Post-marketing Safety Evaluation of Lutathera ( 177 Lu- ... This study aims to conduct a comprehensive analysis of the adverse events (AEs) associated with Lutathera using FDA Adverse Event Reporting System (FAERS) data.

8. jnm.snmjournals.org jnm.snmjournals.org/content/65/5/746

Effectiveness and Safety of Retreatment with 177Lu ... Retreatment with 177 Lu-DOTATATE after progression appeared to be well tolerated and offered disease control in patients with progressive NETs after initial ...

9. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4131

Safety and time to response of [ 177 Lu]Lu-DOTATATE in ... With a median TTR of 5.7 months, most responses to 177 Lu-DOTATATE occurred during scheduled treatment. Overall, the study confirmed the safety profile of 177 ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/lutetium-lu-177-dotatate-intravenous-route/description/drg-20444486

Lutetium lu 177 dotatate (intravenous route) - Side effects & ... Lutetium Lu 177 dotatate injection is used to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors ... Safety ...