Proton Radiation Therapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

Overseen by Shannon MacDonald, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Disqualifiers: Prior radiation, Recent chemotherapy, Pregnancy, others

No Placebo Group

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This research study is evaluating a therapy called proton beam radiation therapy (PBRT) as a possible treatment for neuroblastoma. Neuroblastoma most commonly occurs in and around the adrenal glands, which are located at the top of the kidneys. However, it can also occur in other areas where groups of nerve cells exist, such as other areas of the abdomen, neck and near the spine. Conventional radiation therapy with photons is used as standard treatment for many patients with neuroblastic tumors. In this research study, the investigators are looking at another type of radiation called proton radiation which is known to spare surrounding tissues and organs from unnecessary radiation. Proton radiation delivers radiation to the area requiring radiation. This may reduce side effects that patients would normally experience with standard radiation therapy or other means of delivering proton radiation therapy. In this research study, the investigators are evaluating the effectiveness of using proton radiation delivered to reduce side effects associated with radiation treatment. The investigators will also be assessing the late side effects experienced by participants in each treatment group.

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 data supports the effectiveness of the treatment Proton Beam Radiation Therapy for Neuroblastoma?

Proton therapy for neuroblastoma may help protect nearby healthy organs better than traditional X-ray therapy, and it is considered a promising option because it can reduce side effects while still effectively treating the cancer. ^{1 2 3 4 5}

Is proton radiation therapy safe for treating neuroblastoma in children?

Proton radiation therapy for neuroblastoma in children is generally considered safe, with studies showing few acute side effects and successful completion of treatment without delays. It may also reduce the risk of damage to nearby healthy organs compared to traditional radiation methods. ^{1 3 6 7 8}

How is proton radiation therapy different from other treatments for neuroblastoma?

Proton radiation therapy is unique because it targets tumors more precisely than conventional radiation, reducing damage to surrounding healthy tissues and potentially lowering side effects, which is especially important in treating children with neuroblastoma. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for children and young adults aged 3 to 25 with neuroblastoma or ganglioneuroblastoma. Participants must have confirmed diagnosis, agree to use contraception if of child-bearing age, and have a life expectancy over 12 months. Excluded are those who've had certain prior treatments or cancers, except specific low-risk cases.

Inclusion Criteria

My cancer does not need to be measurable for radiation treatment.

I've had an MRI or CT scan of the area needing treatment within the last 8 weeks.

Participants or their legal guardian must sign consent prior to the initiation of radiation therapy

Exclusion Criteria

Pregnant females are excluded. Women of childbearing age/menstruating must have a negative pregnancy test prior to initiation of radiation therapy.

I have not received radiation therapy above 500 cGy.

I had cancer before, but it's been 5 years and it was not likely to come back, or it was a minor skin cancer or cervical cancer in situ treated within the last 5 years.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive proton radiation therapy daily for 3-4 weeks, Monday through Friday, with each session lasting 30-45 minutes

3-4 weeks

Daily visits (Monday-Friday)

Follow-up

Participants are monitored for late side effects and overall health, with visits 3-6 months post-treatment and annually for up to 5 years

5 years

Initial visit 3-6 months post-treatment, then annual visits

Treatment Details

Interventions

• Proton Beam Radiation Therapy (Proton Beam Therapy)

Trial Overview The study tests proton beam radiation therapy (PBRT) as a treatment for neuroblastoma, aiming to reduce side effects compared to standard photon radiation by sparing surrounding tissues from unnecessary exposure.

Participant Groups

Group I: Proton Beam Radiation Therapy (PBRT) Experimental Treatment 1 Intervention

Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.

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

🇪🇺 Approved in European Union as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

🇺🇸 Approved in United States as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

🇨🇦 Approved in Canada as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

🇯🇵 Approved in Japan as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

🇨🇳 Approved in China as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

🇨🇭 Approved in Switzerland as Proton Therapy for:

• Esophageal adenocarcinoma
• Esophageal squamous cell carcinoma
• Gastroesophageal junction tumors

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

Massachusetts General Hospital Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Children With Neuroblastoma: Experiences From the Prospective KiProReg Registry. [2022] Radiotherapy (RT) is an integral part of the interdisciplinary treatment of patients with high-risk neuroblastoma (NB). With the continuous improvements of outcome, the interest in local treatment strategies that reduce treatment-related side effects while achieving optimal oncological results is growing. Proton beam therapy (PBT) represents a promising alternative to conventional photon irradiation with regard to the reduction of treatment burden.

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy of proton therapy in children with high-risk and locally recurrent neuroblastoma. [2020] Proton therapy is currently used in the management of pediatric tumors to decrease late toxicities. However, one of the criticisms of proton therapy is the limited data regarding efficacy on disease control. The purpose of this study was to examine local and distant control rates after proton therapy for neuroblastoma.

3. United States pubmed.ncbi.nlm.nih.gov

Proton versus photon radiation therapy for patients with high-risk neuroblastoma: the need for a customized approach. [2022] Proton therapy for treatment for high-risk neuroblastoma may offer sparing of organs at risk (OAR) when compared to intensity-modulated X-ray therapy (IMXT).

4. United States pubmed.ncbi.nlm.nih.gov

Assessment of Proton Beam Therapy Use Among Patients With Newly Diagnosed Cancer in the US, 2004-2018. [2022] Proton beam therapy (PBT) is a potentially superior technology to photon radiotherapy for tumors with complex anatomy, those surrounded by sensitive tissues, and childhood cancers.

5. England pubmed.ncbi.nlm.nih.gov

Clinical results of proton beam therapy for advanced neuroblastoma. [2022] To evaluate the efficacy of proton beam therapy (PBT) for pediatric patients with advanced neuroblastoma.

6. United States pubmed.ncbi.nlm.nih.gov

Patient Transfer to Receive Proton Beam Therapy During Intensive Multimodal Therapy is Safe and Feasible for Patients With Newly Diagnosed High-risk Neuroblastoma. [2021] Neuroblastoma (NB) predominantly presents as high-risk disease, requiring intensive multimodal therapy. Proton beam therpy (PBT) is a promising option for many childhood cancers, but is not widely available. Patients with NB hoping to receive PBT may therefore need to be transferred between institutions during intensive multimodal therapy, risking undesirable effects. We evaluated patients with high-risk NB who received PBT at our institute as part of first-line therapy, mainly focusing on the safety and feasibility of mid-treatment patient transfer. Eighteen patients with newly diagnosed high-risk NB who received PBT between April 2010 and June 2016 were retrospectively analyzed for local control, outcomes, and toxicity. Survival (3-y overall survival 71%±11%; 3-y event-free survival 44%±12%) and local control rate (100%) were comparable with previous studies. Few acute adverse events were recorded, and all patients completed PBT without treatment delay. PBT for high-risk NB was safe and feasible for patients requiring mid-treatment interinstitutional transfer.

7. United States pubmed.ncbi.nlm.nih.gov

Outcomes After Proton Therapy for Treatment of Pediatric High-Risk Neuroblastoma. [2021] Patients with high-risk neuroblastoma (HR-NBL) require radiation to the primary tumor site and sites of persistent metastatic disease. Proton radiation therapy (PRT) may promote organ sparing, but long-term outcomes have not been studied.

8. United States pubmed.ncbi.nlm.nih.gov

Acute toxicity of proton beam radiation for pediatric central nervous system malignancies. [2013] Proton beam therapy (PBT) for pediatric CNS malignancies may reduce late toxicity, but acute toxicity is not well defined. We examined acute toxicity for children with CNS malignancies treated with PBT.