Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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+/-).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years

ECOG 0-2

Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix

FIGO IB2 Stadium - IVA (staging 20018)

Disqualifiers

Age <18 years

PS >2

Previous cancer in the last 10 years

Previous radiation treatment in the region of interest

Trial population

Patients with locally advanced cervix cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Interventional Radiotherapy

    Radiation

    The patients will undergo four IRT fractions in one week

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Acute and late gastrointestinal toxicity

Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy

Time frame
6 months
2

Acute and late urinary toxicity

Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy

Time frame
6 months
3

Sexual activity

Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy

Time frame
6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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