BridgeMD
New treatment option for Merkel Cell Carcinoma
Official title Hypofractionated Radiation Therapy for Merkel Cell Carcinoma
ClinicalTrials.gov ID: NCT05100095
What this study is testing
What is Radiation therapy?
Radiation therapy is an investigational medicine, being studied as a potential treatment for merkel cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial tests whether hypofractionated radiation works to treat patients with Merkel cell carcinoma. Radiation therapy uses high energy radio waves to kill cancer cells and shrink tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must have histologically or cytologically confirmed MCC.
- Patients must have no evidence of distant metastasis as determined by clinical examination and any form of imaging.
- If planned for adjuvant primary tumor radiation therapy a patient should have had surgical excision of a primary MCC tumor within 4 months of...
- If planned for adjuvant nodal radiation therapy a patient should have had:
- Prior positive sentinel lymph node biopsy with any degree of nodal involvement within 4 months of starting RT and no completion nodal dissection, or
You likely can't join if
- Previous radiation therapy to the site of planned primary or nodal radiation treatment such that the prior site of treatment would be encompassed by...
- Patients with distant metastases
- Pregnant women are excluded from this study because RT is a known teratogen.
- Patients who are less than 18 years of age becase RT is extremely rare in this population and the treatment agent is a known carcinogen.
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed MCC.
- Patients must have no evidence of distant metastasis as determined by clinical examination and any form of imaging.
- If planned for adjuvant primary tumor radiation therapy a patient should have had surgical excision of a primary MCC tumor within 4 months of starting RT.
- If planned for adjuvant nodal radiation therapy a patient should have had:
- Prior positive sentinel lymph node biopsy with any degree of nodal involvement within 4 months of starting RT and no completion nodal dissection, or
- Lymph node dissection within 4 months of starting RT and high risk nodal disease (receipt of neoadjuvant immunotherapy, ECE, \>1 involved node, \>1 cm nodal disease).
- Immunotherapy is permitted at any time and may specifically be administered prior to RT, concurrent with RT or after RT.
- Age ≥18 years because MCC is extremely rare in patients \<18 years of age and RT is considered high risk in this population due to risk of secondary malignancy and potentially growing tissues that may be adversely...
- ECOG performance status ≤3.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- RT is a known teratogen. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the...
- Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of RT.
- Ability to understand and the willingness to sign a written informed consent document. Expansion cohort
- Patient would have received \<50.4 Gy using conventional radiotherapy dose-fractionation if not enrolled.
- Previous radiation therapy to the site of planned primary or nodal radiation treatment such that the prior site of treatment would be encompassed by the radiation field needed to treat the current cancer. In other...
- Patients with distant metastases
- Pregnant women are excluded from this study because RT is a known teratogen.
- Patients who are less than 18 years of age becase RT is extremely rare in this population and the treatment agent is a known carcinogen.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.