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Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy followed by interventional radiotherapy in patients affected by vaginal cancer
Prospective observational multicenter study, aimed at evaluating the effectiveness on local control and cancer-specific survival of radiochemotherapy (45Gy on pelvis and tumor plus chemotherapy with cisplatinum) followed by interventional radiotherapy (28Gy on residual tumor) in patients affected by vaginal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with vaginal cancer | Patients affected by vaginal cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiochemotherapy plus interventional radiotherapy | Radiation | All patients with vaginal cancer will undergo radiochemotherapy (45 Gy on pelvis and tumor in association with cisplatinum) plus interventional radiotherapy (28 Gy on residual disease) with exclusive intent |
| Measure | Description | Time Frame |
|---|---|---|
| Local Control | Local control, the Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer specific overall survival | The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment | 6 months |
| Toxicities |
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Inclusion Criteria:
Exclusion Criteria:
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Women with vaginal cancer that after first consultation will undergo to radiochemotherapy and interventional radiotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VALENTINA LANCELLOTTA, MD | Contact | +390630155701 | valentina.lancellotta@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| VALENTINA LANCELLOTTA | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D014625 | Vaginal Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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The safety and tolerability profile of the treatment will be defined by the frequency and severity of adverse reactions as well as their possible correlation with the treatment received. |
| 6 months |
| Overall survivall | The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment | 6 months |
| Disease free survivall | The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment | 6 months |
| Metastasis free survival | The Cox regression model and multivariable logistic analysis will be used to analyze the role of clinical-pathological parameters as prognostic and predictive factors of pathological response to treatment | 6 months |
| Changes in quality of life over time | Anova for repeated measures or the corresponding non-parametric Friedman test will be used to identify changes in quality of life over time. | 6 months |
| D014623 |
| Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |