Main objective: response rate and tumour size reduction by neoadjuvant chemotherapy.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
response rate and tumour size reduction by neoadjuvant chemotherapy. Morbidity
and complication assessment
Secondary outcome
Secondary objectives are the avoidance of exenterative or invalidating surgery.
Chemotherapy related morbidity will be monitored as well as be disease free and
overall survival and patterns of recurrence.
Background summary
Vulvar cancer is a rare malignancy. Surgery is the treatment of choice, but
frequently causes invalidating and chronic postoperative morbidity, especially
in patients with high stage disease. Theoretically, downstaging with
neoadjuvant chemotherapy could shrink the tumour, making surgical treatment
less extensive thereby diminishing the chance for morbidity.
Study objective
Main objective: response rate and tumour size reduction by neoadjuvant
chemotherapy.
Study design
a prospective, multi-centre phase II trial to investigate the response rate of
carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma.
Intervention
a maximum of 6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3
weekly schedule
Study burden and risks
- 1 to 4 extra site visits, namely before every new chemotherapy cycle.
- during these visits blood (2 tubes) will be investigated to check if the next
chemotherapy cycle can be given safely.
- 1 extra visit after the 3rd cycle of chemotherapy for a gynaecological
physical examination with measurement of the primal lesion(s) and a photo will
be taken with a ruler.
- an extra biopsy of the tumour can be taken before starting chemotherapy or at
the start of the operation, to investigate the microenvironment in relation to
response.
- risks associated with the treatment are those already known: for example low
amount of blood cells with risk of delaying (or not continuing) chemotherapy or
wound infection or breakdown in case of an operation
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
• Woman >= 18 years
• Signed and written informed consent.
• Histologically confirmed squamous cell vulvar carcinoma
• World Health Organization performance status of 0-2
• Adequate hematological function
• Adequate hepatic function
• Adequate renal function
• Negative pregnancy test for woman of childbearing potential
• measurable disease by physical examination
• TNM stage T2, any N, M0
Exclusion criteria
• Vulvar cancer other than squamous cell carcinoma at biopsy
• Previous radiotherapy of the vulva, groins or pelvis
• Patients with metastasis limited to the pelvic lymph nodes, who can be
primarily operated with curative intent
• Other diagnosis of malignancy or evidence of other malignancy for 5 years
before screening for this study
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 | EUCTR2019-003104-12-NL |
| ClinicalTrials.gov | NCTnummervolgt |
| CCMO | NL71004.031.19 |