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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first two years after primary treatment
Awards & highlights
GROINSS-VIII Trial Summary
This trial recommends chemo+radiation instead of a surgery for vulvar cancer patients with advanced spread of the disease.
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.Check my eligibility
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.See study design
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.
GROINSS-VIII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is a type of skin cancer called SCC located in the vulva.
Select...
My tumor is smaller than 4cm.
Select...
My tumor is small and not near my urethra, vagina, or anus.
Select...
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).
Select...
My cancer has spread to a sentinel lymph node with a size greater than 2mm and/or has grown outside the lymph node.
Select...
My kidneys work well enough to clear at least 40 ml/min of creatinine.
Select...
I have only one tumor.
GROINSS-VIII Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Groin recurrence rate
Secondary outcome measures
Quality of life as assessed using EORTC-QLQc30
Quality of life-vulvar cancer specific, as assessed using VU34
Treatment related morbidity
GROINSS-VIII 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
Find a Location
Who is running the clinical trial?
NRG OncologyOTHER
231 Previous Clinical Trials
100,695 Total Patients Enrolled
Dutch Cancer SocietyOTHER
108 Previous Clinical Trials
75,508 Total Patients Enrolled
University Medical Center GroningenLead Sponsor
718 Previous Clinical Trials
979,761 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor cannot be removed with surgery and is larger than 4cm.My cancer is a type of skin cancer called SCC located in the vulva.My tumor is smaller than 4cm.I haven't had any cancer except for basal cell skin cancer in the last 5 years.My tumor is small and not near my urethra, vagina, or anus.My cancer has spread to a sentinel lymph node with a size greater than 2mm and/or has grown outside the lymph node.I have had radiation treatment in my pelvic area.I haven't been hospitalized or needed antibiotics for an infection in the last 2 weeks.I am 18 years old or older.My cancer has spread to my lymph nodes, confirmed by a needle test.I can take care of myself and am up and about more than half of my waking hours.My cancer has spread to more than one lymph node, but each spread is tiny (2mm or less).My brain or spinal cord cancer has been treated, is not getting worse, and I'm stable without needing seizure medicine or steroids.I have cancer in more than one spot.My kidneys work well enough to clear at least 40 ml/min of creatinine.I want to become pregnant.I haven't had major heart issues or strokes in the last 6 months.I have only one tumor.My kidney, liver, and bone marrow are functioning well.My cancer is not squamous cell carcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: Chemoradiation
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What type of medical conditions is Chemoradiation typically deployed to address?
"Chemoradiation may be an effective treatment for advanced ovarian cancer, testicular cancer that has not responded to conventional treatments, and other refractory conditions."
Answered by AI
Are there any available openings left for participants in this clinical trial?
"According to clinicaltrials.gov, this is a live trial and was initially published on January 1st 2021 with the most recent modification occurring on July 27th 2023."
Answered by AI
Has there been any additional research conducted on the combination of chemotherapy and radiation therapy?
"Chemoradiation was initially examined in 1997 at City of Hope Comprehensive Cancer Center, and since then there have been enough studies completed to total 980. There are currently 586 live clinical trials taking place, many originating from Orange, California."
Answered by AI
Is Chemoradiation an effective and secure treatment option?
"Since this is a Phase 2 trial, there are some preliminary data that suggest the safety of chemoradiation; thus, it was assigned a rating of 2."
Answered by AI
How many individuals have been included in this medical research endeavor?
"Affirmative. As reported on clinicaltrials.gov, this medical trial has been open for recruitment since January 1st 2021 and is still actively taking in participants. 157 people from 27 locations are needed to join the research study."
Answered by AI
How prevalent are the sites running this experiment within the state boundaries?
"Currently, 27 sites are enrolling patients for this trial. Locales include Orange, Miami Beach and Springfield amongst other places. To minimize travel demands when partaking in the study, it is suggested to choose a site close to your residence."
Answered by AI
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