E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced stage squamous cell cancer of the vulva |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10047777 |
E.1.2 | Term | Vulvar cancer |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 • Measurable disease at least locally (vulvar area) • Pretreatment laboratory values: - Hb> 6.5 mmol/l - Neutrophil count> 1.5 x 109/l - Platelets ≥ 100 x 109/l - Bilirubin < 25µmol/l - Adequate liver function: ALAT and ASAT < 2.5 upper normal limit - Alkaline phosphatase < 2.5 upper normal limit • No upper age limit specified. Patients should mentally, physically and geographically be able to undergo treatment and follow-up • Patients must be > 18 years old • Written informed consent • No psychosis, CNS disease or other expected difficulty for follow-up • No active uncontrolled infection • No concomitant or previous malignancy other than basal cell carcinoma of the skin or CIN of the cervix
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
locoregional control rate defined as clinically or pathologically proven absence of tumor (CR according to RECIST criteria) in the vulvar area, groins and/or pelvis 12 weeks after the end of radiochemotherapy and after groin dissection in cN1,2 patients. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |