What is the mechanism of action of this treatment?

Chemoradiation, a combination of chemotherapy and radiation therapy, is a common treatment for Sentinel Lymph Node (SLN) metastasis. Chemotherapy sensitizes cancer cells to radiation, enhancing the effectiveness of radiation therapy. This approach is crucial for SLN patients as it improves local disease control and may reduce the need for extensive surgery. Additionally, it targets micrometastatic disease that might not be detectable through imaging or surgery, thereby improving overall treatment outcomes.

What side effects are associated with this type of intervention?

The most common treatments for Sentinel Lymph Node biopsy, particularly chemoradiation, can cause a range of side effects. Chemotherapy may lead to nausea, vomiting, hair loss, fatigue, and increased infection risk. Radiation therapy can cause skin irritation, localized pain, and fatigue. When combined as chemoradiation, these treatments can intensify each other's side effects, resulting in more severe fatigue, gastrointestinal issues, and a higher risk of infections.

What prior FDA approvals exist?

FDA approvals for the treatment of conditions involving the Sentinel Lymph Node often include chemoradiation approaches, where chemotherapy is used to sensitize cancer cells to radiation, enhancing its effectiveness. For example, in vulvar cancer, patients with sentinel node metastasis greater than 2mm may receive chemoradiation instead of more extensive surgical procedures like inguinofemoral lymphadenectomy. This approach aims to reduce surgical morbidity while effectively managing the disease.

What other types of research exist?

For Sentinel Lymph Node patients, promising novel alternatives to chemoradiation include the use of oral kinase inhibitors such as selpercatinib or pralsetinib for RET-mutated tumors, and cabozantinib or vandetanib for non-RET mutated tumors. These therapies can provide long-term disease stabilization and delay progression. Additionally, systemic treatments as part of clinical trials, especially those involving immunotherapy or targeted therapy, are also promising alternatives.

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Alkylating agents

Chemoradiotherapy for Advanced Vulvar Cancer (GROINSS-VIII Trial)

Phase 2

Recruiting

Research Sponsored by University Medical Center Groningen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histological confirmed primary SCC of the vulva

Tumor diameter < 4cm

Must not have

Inoperable tumors and tumors > 4cm

No other carcinomas, other than basal cell carcinomas, within last 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first two years after primary treatment

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing a combination of chemotherapy and radiation therapy for early-stage vulvar cancer patients with larger or multiple metastases. The goal is to find a less invasive but effective alternative to surgery. The treatment uses drugs and high-energy rays to kill cancer cells.

Who is the study for?

This trial is for adults with a specific type of vulvar cancer (SCC) that's less than 4cm, not spread to large lymph nodes or other body parts. Participants must have small metastases in sentinel lymph nodes and be healthy enough overall to give consent and follow the study plan.

What is being tested?

Patients with certain vulvar cancer will receive chemoradiation therapy instead of surgery to remove groin lymph nodes. The treatment includes Cisplatin, a chemotherapy drug, combined with radiotherapy aimed at reducing cancer spread.

What are the potential side effects?

Chemoradiation can cause side effects like nausea, fatigue, skin reactions in treated areas, low blood cell counts increasing infection risk, kidney function changes, and potential damage to nearby organs such as the bladder.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of skin cancer called SCC located in the vulva.

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My tumor is smaller than 4cm.

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My tumor is small and not near my urethra, vagina, or anus.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer has spread to more than one lymph node, but each spread is tiny (2mm or less).

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My cancer has spread to a sentinel lymph node with a size greater than 2mm and/or has grown outside the lymph node.

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My kidneys work well enough to clear at least 40 ml/min of creatinine.

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I have only one tumor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor cannot be removed with surgery and is larger than 4cm.

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I haven't had any cancer except for basal cell skin cancer in the last 5 years.

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I have had radiation treatment in my pelvic area.

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I haven't been hospitalized or needed antibiotics for an infection in the last 2 weeks.

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My cancer has spread to my lymph nodes, confirmed by a needle test.

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I have cancer in more than one spot.

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I want to become pregnant.

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My cancer is not squamous cell carcinoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within first 2 years after primary treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within first 2 years after primary treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and within first 2 years after primary treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Groin recurrence rate

Secondary study objectives

Quality of life as assessed using EORTC-QLQc30

Quality of life-vulvar cancer specific, as assessed using VU34

Treatment related morbidity

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ChemoradiationExperimental Treatment2 Interventions

Inguinofemoral radiotherapy (48-50 Gy in 1.8 Gy daily fractions, with a boost dose to the involved inguinal site for a total equivalent dose of 56 Gy over 5-6 weeks, preferably with simultaneous integrated boost technique) combined with weekly cisplatin 40 mg/m2 intravenously on days 1, 8, 15, 22 and 29

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cisplatin

FDA approved

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chemoradiation, a combination of chemotherapy and radiation therapy, is a common treatment for Sentinel Lymph Node (SLN) metastasis. Chemotherapy sensitizes cancer cells to radiation, enhancing the effectiveness of radiation therapy. This approach is crucial for SLN patients as it improves local disease control and may reduce the need for extensive surgery. Additionally, it targets micrometastatic disease that might not be detectable through imaging or surgery, thereby improving overall treatment outcomes.

Editorial: Therapy-induced metastasis.Pediatric Hodgkin Lymphoma.First-line chemotherapy of non-seminomatous germ cell tumors(NSGCTs).