Clinical Study on the Re-irradiation of Lateral Pelvic Recurrences of Gynecological Malignancies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCNAO National Center of Oncological Hadrontherapy

About this trial

The study aims to obtain a local control rate in patients with lateral pelvic relapses of gynecologycal cancers previously irradiated. High LET (Linear Energy Transfer) particles as carbon ions can guarantee a biologic advantage compared to photons in radioresistant neoplasms, given to their higher biological efficacy (RBE).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients ≥ 18 years of age

Karnofsky Index ≥ 70

Histological or radiological diagnosis of pelvic and groin recurrence

Contraindications for radical surgery

Disqualifiers

Hip prosthesis, metal prostheses or any other condition that prevents adequate imaging to identify the target volume and calculate the dose in the treatment plan

Intestinal infiltration

Bladder infiltration

Vessel infiltration

Trial design

Design model

Single group

Treatments tested in this trial

  • carbon ion radiation therapy

    Radiation

    CIRT: Planning Target Volume (PTV) will be delivered a total dose of 48-52.8 GyRBE in 12 fractions, 4 fractions per week. Treatment duration 3 weeks. Treatment lasting more than 5 weeks or cases of treatment with less than 6 fractions in 14 consecutive days will not be accepted.

Treatment groups

55 Participants
are divided into 1 treatment group
Group A: carbon ion radiotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

local control

absence of progression disease, in patients with lateral pelvic recurrences of gynecological malignancies

Time frame
1 year after treatment
2

complete response

complete regression of the tumor lesion

Time frame
1 year after treatment
3

partial response

Reduction of the tumor volume \> 65% of the initial volume

Time frame
1 year after treatment
4

stable disease

Volume between PR and PD

Time frame
1 year after treatment

Secondary outcomes

1

overall survival

overall survival

Time frame
1 year after treatment
2

Toxicity assessment according to CTCAE v. 5

Tto define acute, intermediate and late toxicities according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0)

Time frame
1 year after treatment
3

Progression free survival

Progression free survival (PFS) with qualitative evaluation as a narrative of progression

Time frame
1 year after treatment

Other outcomes

Sponsors and contacts

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