The primary objective is to gain experience with primary radiochemotherapy and to determine the locoregional response rate at 12 weeks after radiochemotherapy and after groin dissection for cN1,2 patients.
ID
Source
Brief title
Condition
- Reproductive neoplasms male malignant and unspecified
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to gain experience with primary radiochemotherapy and
to determine the locoregional response rate at 12 weeks after radiochemotherapy
and after groin dissection for cN1,2 patients.
Secondary outcome
The secondary objective would be to determine short-term morbidity defined as
desquamation of the skin, infection, long-term morbidity defined as edema,
fibrosis, the incidence of fecal and or urinary continence, and or incidence of
reconstructive surgery performed and treatment related mortality. Longterm
morbidity and the rate of locoregional recurrences will be evaluated at 24
months after the end of radiochemotherapy.
Background summary
Cancer of the vulva is a relatively rare disease with an annual incidence of
2-3 per 100.000 women. In the Netherlands each year 150-200 new patients are
diagnosed with vulvar cancer In 30% of the patients tumors are classified as
T3/T4 tumors with either extension of the tumor to the vagina, the proximal
urethra or anus (cT3) or extension to the upper urethra or bladder, upper anal
canal or rectum or the tumor is fixed to the pubic bone (cT4). The primary
tumor causes serious local problems such as pain while sitting, discharge,
bleeding from necrotic tumor and a faul odor. Positive lymph nodes are found
in 50%-60% of patients with T3/T4 tumors. Frequently these nodes are ulcerating
and or fixed to the femoral vessels in the groin. These patients presenting
with locally advanced disease (cT3/T4) pose a specific problem regarding the
treatment. Traditionally exenterative surgery with stoma formation was the only
available treatment.
Recently patients with locally advanced vulvar cancer (carcinoma of the vulva
with unresectable N2/N3 groin lymph nodes) were treated with a combination of
4760 cGy radiotherapy (daily fractions 2 x 170 cGy and given as split course
with an interval of 1* to 2* weeks) combined with concurrent chemotherapy
(cisplatin and 5-FU). This resulted in the prevention of either a uro- or
colostomy in 49 of 50 patients, although postoperative wound complications were
frequent.
Therefore studies using a higher radiation dose combined with chemotherapy
resulting in a higher local control rate precluding salvage surgery are
warranted.
Study objective
The primary objective is to gain experience with primary radiochemotherapy and
to determine the locoregional response rate at 12 weeks after radiochemotherapy
and after groin dissection for cN1,2 patients.
Study design
The trial is a non-randomized multi-centre phase II study
Intervention
Lymph node debulking of enlarged groin lymph nodes (if applicable) followed by
chemoradiotherapy towards the vulva and groins.
Study burden and risks
There is a higher risk on radiation related morbidity like vulvair and groin
desquamation and diarrhoe.
Meibergdreef 9
1105AZ Amsterdam
NL
Meibergdreef 9
1105AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
• squamous cell cancer of the vulva with locally advanced disease not curable with surgery unless extensive reconstructive surgery or a colostomy or urostomy is performed
• Amenable to curative treatment
• No disease present outside the pelvis
• Performance status WHO 0-2
• Patients must be fit enough to undergo salvage surgery after chemo radiotherapy
Exclusion criteria
none
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-004052-20-NL |
| CCMO | NL13743.018.06 |