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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-06904 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2020-0148 | Other Identifier | M D Anderson Cancer Center |
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This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.
PRIMARY OBJECTIVE:
I. To determine if regional nodal radiation therapy prolongs the time to regional recurrence.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive adjuvant immunotherapy and nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks).
GROUP II: Patients receive adjuvant immunotherapy alone.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (immunotherapy, radiation therapy) | Experimental | Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB. |
|
| Group II (immunotherapy) | Active Comparator | Patients planned to undergo immunotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapy | Other | All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to regional nodal recurrence | Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up | From date of sentinel lymph node biopsy, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to locoregional recurrence | Local recurrence, locoregional recurrence (including both regional recurrence and local recurrence at the primary tumor site) will also be assessed by physical exam and routine surveillance imaging during follow-up. | From date of sentinel lymph node biopsy, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Tissue associated biomarkers of disease control and radiation-associated toxicity | Up to 5 years | |
| Optional blood associated biomarkers of disease control and radiation-associated toxicity | Up to 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Devarati Mitra | Contact | 713-563-1339 | dmitra@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Devarati Mitra | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist - MD Anderson Cancer Center | Recruiting | Jacksonville | Florida | 32207 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D007167 | Immunotherapy |
| D000276 | Adjuvants, Immunologic |
| D011878 | Radiotherapy |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007155 | Immunologic Factors |
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Radiation Therapy | Radiation | Undergo nodal radiation therapy |
|
|
| Time to distant metastasis |
Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up. |
| From date of sentinel lymph node biopsy, assessed up to 5 years |
| Progression-free survival | From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years |
| Overall survival | From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years |
| Incidence of long term toxicity | Long term toxicity including lymphedema, infection, decreased mobility will be assessed at the time of routine follow up appointments. Physician-reported toxicity related to regional nodal disease or treatment will be recorded as per Common Terminology Criteria for Adverse Events version 5.0. Specific toxicity to be evaluated will include: fatigue, localized edema, lymphedema, pain, skin infection, soft tissue infection, thrush, radiation recall reaction, arthritis, fibrosis, joint range of motion, dysphagia, dysgeusia and dry skin. | Up to 5 years |
| Patient reported quality of life | Quality of life in all patients will be assessed by Functional Assessment of Cancer Therapy General survey. Patients with head and neck nodal disease will also be assessed by the University of Washington Quality of Life survey and patients with axillary nodal disease will also be assessed by the Lymphoedema Quality of Life-ARM. | At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy |
| Cooper Hospital UNIV MED CTR. | Recruiting | Camden | New Jersey | 08103 | United States |
|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D045505 |
| Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D055585 | Physical Phenomena |