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Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)

Sponsor
The Netherlands Cancer Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04192253
Collaborator
(none)
51
Enrollment
1
Location
1
Arm
107.6
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Paclitaxel and Carboplatin
 Phase 2

Detailed Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
a prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinomaa prospective, phase ll trial to investigate the response rate of carboplatin and paclitaxel in patients with locally advanced vulvar carcinoma
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Locally Advanced VULvar CArcinoma in a Neoadjuvant Setting With Carboplatin and Paclitaxel Chemotherapy (VULCANize)
Actual Study Start Date :
Jan 14, 2020
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: neo-adjuvant Paclitaxel and Carboplatin

Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

Drug: Paclitaxel and Carboplatin
Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule

Outcome Measures

Primary Outcome Measures

  1. tumour size change by neoadjuvant chemotherapy [18 weeks]

    tumour size change by neoadjuvant chemotherapy measured by RECIST 1.1

Secondary Outcome Measures

  1. avoidance of exenterative or invalidating surgery [21 weeks]

    number of patients were surgery can be reduced after the neo-adjuvant chemotherapy

  2. Chemotherapy related morbidity [21 weeks]

    Chemotherapy related morbidity measured by reported adverse events

  3. overall survival [5 years after treatment]

    overall survival

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Woman k 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, MO

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 NKI-AVL Amsterdam Netherlands 1066CX

Sponsors and Collaborators

  • The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Frederic Amant, MD, PHD, NKI-AvL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT04192253
Other Study ID Numbers:
  • M19VLC
First Posted:
Dec 10, 2019
Last Update Posted:
Jun 29, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma
Vulvar Neoplasms
Paclitaxel
Carboplatin

Study Results

No Results Posted as of Jun 29, 2020