Locally Advanced Cervical Carcinoma
Conditions
Keywords
cervical carcinoma, interventional radiotherapy, acute and late toxicities, radiochemotherapy
Brief summary
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+/-).
Detailed description
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.
Interventions
RADIATIONInterventional Radiotherapy
The patients will undergo four IRT fractions in one week
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years * ECOG 0-2 * Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix * FIGO IB2 Stadium - IVA (staging 20018) * No contraindications to performing MRI of the pelvis * Informed consent
Exclusion criteria
* Age \<18 years * PS \>2 * Previous cancer in the last 10 years * Previous radiation treatment in the region of interest * Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation) * Presence of internal diseases that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.) * Presence of distant metastases in sites other than the pelvic lymph nodes * Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute and late gastrointestinal toxicity | 6 months | Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy |
| Acute and late urinary toxicity | 6 months | Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy |
| Sexual activity | 6 months | Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy |
Countries
Italy
Contacts
Primary ContactVALENTINA LANCELLOTTA
Outcome results
None listed