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To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).
Observational, monocentric and prospective study. All patients with locally advanced cervix cancer will be underwent to radiochemotherapy followed by accelerated interventional radiotherapy (brachytherapy). Fist endpoints wer severe acute and late gastrointestinal, and urinary toxicities and sexual activity.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional Radiotherapy | Radiation | The patients will undergo four IRT fractions in one week |
| Measure | Description | Time Frame |
|---|---|---|
| Acute and late gastrointestinal toxicity | Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy | 6 months |
| Acute and late urinary toxicity | Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy | 6 months |
| Sexual activity | Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with locally advanced cervix cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VALENTINA LANCELLOTTA | Contact | 3441177911 | valentina.lancellotta@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| VALENTINA LANCELLOTTA | Fondazione Universiataria Policlinico A Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli, IRCCS | Recruiting | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |