Description:
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.
Title
- Brief Title: Nodal Radiation Therapy for Sentinel Lymph Node Positive Melanoma
- Official Title: The Role of Nodal Radiation Therapy in Sentinel Lymph Node Positive Melanoma
Clinical Trial IDs
- ORG STUDY ID:
2020-0148
- SECONDARY ID:
NCI-2020-06904
- SECONDARY ID:
2020-0148
- NCT ID:
NCT04594187
Conditions
Purpose
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.
Detailed Description
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.
Trial Arms
Name | Type | Description | Interventions |
---|
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. | |
Eligibility Criteria
Inclusion Criteria:
- Must be planned for post-operative immunotherapy
- No evidence of distant metastasis as determined by clinical examination and any form
of imaging
- No evidence of clinically involved lymph nodes prior to SLNB
- Pathologically confirmed sentinel lymph node positive melanoma with high risk features
(extracapsular extension [ECE] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or
lymphovascular invasion of the primary tumor)
- Has provided written informed consent for participation in this trial
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
- Life expectancy greater than 6 months
- Patients capable of childbearing are using adequate contraception
- Available for follow-up
Exclusion Criteria:
- Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
- Distant metastasis
- Previous radiation therapy (RT) to the nodal area planned for RT such that the prior
RT field would be included in the current treatment field. In other words, treatment
on this trial would require re-irradiation of tissues
- Women who are pregnant
- Adults unable to consent, individuals who are not yet adults, pregnant women and
prisoners will be excluded from this study
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Time to regional nodal recurrence |
Time Frame: | From date of sentinel lymph node biopsy, assessed up to 5 years |
Safety Issue: | |
Description: | Regional nodal recurrence will be assessed by physical exam and routine surveillance imaging during follow-up |
Secondary Outcome Measures
Measure: | Time to locoregional recurrence |
Time Frame: | From date of sentinel lymph node biopsy, assessed up to 5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Time to distant metastasis |
Time Frame: | From date of sentinel lymph node biopsy, assessed up to 5 years |
Safety Issue: | |
Description: | Distant metastasis will also be assessed by physical exam and routine surveillance imaging during follow-up. |
Measure: | Progression-free survival |
Time Frame: | From date of sentinel lymph node biopsy to recurrence event or last follow-up, assessed up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival |
Time Frame: | From date of sentinel lymph node biopsy to last follow-up, assessed up to 5 years |
Safety Issue: | |
Description: | |
Measure: | Incidence of long term toxicity |
Time Frame: | Up to 5 years |
Safety Issue: | |
Description: | 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. |
Measure: | Patient reported quality of life |
Time Frame: | At baseline, 3 months after sentinel lymph node biopsy, 9 months after sentinel lymph node biopsy, and 2 years after sentinel lymph node biopsy |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | M.D. Anderson Cancer Center |
Last Updated
June 25, 2021