CLINICAL TRIAL

Proton Beam radiation for Germ Cell Cancer

Waitlist Available · < 65 · All Sexes · Boston, MA

This study is evaluating whether proton beam radiation therapy will kill the germ cell tumor in the participant's central nervous system.

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About the trial for Germ Cell Cancer

Eligible Conditions
Neoplasms, Germ Cell and Embryonal · Germ Cell Tumors · Neoplasms · Central Nervous System Germ Cell Tumor

Treatment Groups

This trial involves 2 different treatments. Proton Beam Radiation is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Proton Beam radiation
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Participants do not need to have measurable disease. Most patients will not have measurable disease at the time of treatment.
3 years of age or older and 25 years of age or younger at the time of diagnosis because this study evaluates this disease entity in the pediatric population which may differ from the adult population.
Life expectancy of greater than 12 months.
ECOG performance status of 0, 1 or 2
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Proton Beam radiation will improve 2 primary outcomes and 1 secondary outcome in patients with Germ Cell Cancer. Measurement will happen over the course of 2 years.

To evaluate acute and subacute toxicities of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation in this patient population.
2 YEARS
To describe late complications of craniospinal, whole ventricle, and involved field radiation therapy delivered with proton radiotherapy in place of photon radiation for this patient population.
2 YEARS
To determine 3 year progression free survival rate of patients with pure germ cell tumors and non-germinomatous germ cell tumors treated with proton radiation.
3 YEARS

Who is running the study

Principal Investigator
S. M.
Shannon MacDonald, MD
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is germ cell cancer?

Germ cell cancers are uncommon but have significant implications for an individual as the disease can affect a variety of bodily functions. More than 5% of germ cell cancers were classified as nonseminomatous testicular cancer.

Anonymous Patient Answer

What are the signs of germ cell cancer?

This is the most common childhood cancer in boys. Approximately 13-19% of boys of all ages will be diagnosed with a germ cell cancer.  Most germ cell cancers present as a mass, usually in one of the pelvic organs such as the testis or ovary. Rarely, it may present as a retrocecal mass, an epididymal mass or abdominal pain as an abdominal germ cell tumor.

Anonymous Patient Answer

Can germ cell cancer be cured?

Germ cell tumors should not be treated as if they are benign or pre-malignant, as they can occur at any age from 4 months gestational age. Treatment should be based on stage and grade. Treatment must be tailored to minimize the burden of treatment. Long-term (10 years) cure or control seems to be possible in many patients.

Anonymous Patient Answer

What are common treatments for germ cell cancer?

The treatment of germ cell cancers involves surgery, chemotherapy and radiotherapy in order to eradicate cancer cells and improve survival. When complete surgery and chemotherapy are not performed, prognosis will depend on the extent of disease and whether further chemotherapy is necessary.

Anonymous Patient Answer

What causes germ cell cancer?

Germ cell tumors can occur spontaneously or be caused by exposure to toxic substances and/or radiation. They may present as both benign (teratoma) and malignant tumors, with the most common form being diffuse spermatocytic seminoma. Testicular cancer can be treated conservatively depending on the patient's age, with the most recent evidence suggesting cryotherapy and watchful waiting with active surveillance before or after chemotherapy is required in young adult patients. Chemotherapies have been used by more than 50% of patients with seminoma, but the extent and duration of use are variable. If chemotherapy is used, there is high cure rate but high rate of secondary treatments.

Anonymous Patient Answer

How many people get germ cell cancer a year in the United States?

About 11,600 cases of germ cell cancer will be diagnosed in the year 2020. (1.4 per 10,000) Germ cell cancers represent about 7% of all malignant neoplasms (both solid and soft tissue) in the United States. (0.5 per 10,000.) This incidence has been steadily increasing since the late 1980s. The annual incidence of germ cell cancer is also higher in men than in women. Of the approximately 300,000 cases of germ cell malignancies (both seminoma, nonseminoma, and testis interstitial cell), approximately 170,000 to 200,000 are malignant teratomas, 25% of which are gonadal teratomas.

Anonymous Patient Answer

What are the chances of developing germ cell cancer?

These data suggest that, in a population with a low risk of developing germ cell cancer, a history of two or more testicular cancer diagnoses increased the risk more than three-fold. In addition, the incidence of all germ cell cancers continues to increase, with an increase in yolk sac tumors perhaps most notable. These statistics may be useful in assessing germ cell cancer risks in a population at which individuals may be counseled to postpone fertility therapy until the risk of germ cell tumor exposure has passed.

Anonymous Patient Answer

Does germ cell cancer run in families?

The rate of germ cell cancer among the family members in this population of women is not significantly different from the rate outside the family. We did not find a disproportionate number in families with other forms of cancer.

Anonymous Patient Answer

What is the latest research for germ cell cancer?

Germ cell tumors are considered to be tumors of gonadal and extra-gonadal origin, although the origin of some tumors may be the [liver(liver). This article summarizes the updated research for germ cell cancers in order to increase the knowledge of the disease and its diagnosis, progression, and treatment. Germ cell tumors may develop out of [germ cells, which are immature germ cells/sperm that can develop into oocytes and sperm in females or gametocytes and spermatocytes in males] The most common germ cell tumour is [epithelial germ cell tumor (yolk sac germ cell tumor)]; <2% are testicular tumors and <0.2% are non-gonadal.

Anonymous Patient Answer

Has proton beam radiation proven to be more effective than a placebo?

The authors report good local control at the irradiated site and no recurrence of tumors. We recommend proton beam radiation as a standard treatment for the treatment of unresectable metastatic seminoma, preferably in combination with additional chemotherapy.

Anonymous Patient Answer

Who should consider clinical trials for germ cell cancer?

Germ cell cancer may be appropriately treated with low toxicity levels of chemotherapy drugs. The decision to participate in clinical trials is best made with patient education, as these trials can have significant side-effects. Clinicians should be familiar with these most recent trials to make the best decision for each patient.

Anonymous Patient Answer

Have there been other clinical trials involving proton beam radiation?

There is a very small amount of clinical data regarding proton beam-radiation in treating GCTs. While not as common, metastatic disease, or [locally administered] radiotherapy, proton beam therapy is being investigated for its benefit and toxicity. Further study is needed to better define the effectiveness of the newer techniques.

Anonymous Patient Answer
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