Study on Chemoradiation Instead of Surgery for Vulvar Cancer with Larger Sentinel Node Metastasis

Sponsor: University Medical Center Groningen

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05076942

Provider View

This clinical trial is exploring whether using a combination of chemotherapy and radiation therapy can safely replace surgery for patients with early-stage vulvar cancer who have larger metastasis in their sentinel lymph nodes.

Patient Parameters

Program Overview

The study aims to find out if chemoradiation, which combines chemotherapy and radiation, can be a safe alternative to surgery for treating early-stage vulvar cancer when the cancer has spread to the sentinel lymph nodes with metastasis larger than 2mm. Surgery can lead to complications like wound healing issues and leg swelling. Previous studies showed that radiation alone was not enough for larger metastasis, so this study will test if adding chemotherapy can improve treatment outcomes.

Description

The standard treatment for early-stage vulvar cancer involves removing the tumor and checking the groin lymph nodes. If cancer is found in these nodes, more extensive surgery is usually done, which can cause significant side effects. This study is testing if a combination of chemotherapy and radiation can replace this surgery for patients with larger cancer spread in their lymph nodes.

The main goal is to see if this new approach is safe and effective in preventing cancer from returning in the groin area. The study will also look at the side effects of this treatment compared to surgery.

Participants will receive chemoradiation over 5 weeks, with a total radiation dose of 56Gy and weekly chemotherapy with cisplatin. The study will closely monitor the rate of cancer returning in the groin to ensure the treatment is working as expected.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with primary squamous cell carcinoma of the vulva.
  • Tumor is small (less than 4cm) and not invading nearby organs like the urethra, vagina, or anus.
  • Cancer has spread to the sentinel lymph node with metastasis larger than 2mm or more than one node with smaller metastasis.
  • No enlarged or suspicious lymph nodes on imaging tests.
  • Able to understand and agree to the study requirements and provide written consent.
  • Good overall health with adequate blood counts and organ function.
  • Age 18 or older with a life expectancy of at least 12 weeks.
  • Performance status of 0, 1, or 2, meaning fully active or able to carry out light work.

Exclusion Criteria

  • Tumors larger than 4cm or inoperable.
  • Multiple tumors or other types of cancer in the last 5 years, except for certain skin cancers.
  • Enlarged lymph nodes proven to have cancer.
  • Previous pelvic radiation therapy.
  • Recent serious infections or hospitalization.
  • Pregnant or nursing women, or those planning to become pregnant.
  • Known brain or spinal cord cancer unless treated and stable.
  • Recent severe heart problems or stroke.

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