Cancer Help Guide

Adrenocortical carcinoma · 2026-525406-36-00

Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma.

Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma

Status
Authorised (EU CTIS)Approved to run; CTIS does not say whether it is recruiting — ask the site
Phase
Phase 2
Sponsor
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Registry records
Registry last updated 2026-09-03

Eligibility, line by line

VerdictIn plain words (machine summary)Registry text, verbatimIf unmet
inclusion
inclusion · age sex · confidence 0.97
Male and females ≥18 years of age"Male and females ≥18 years of age"
inclusion
inclusion · condition · confidence 0.95
Patients with preoperative diagnosis of ACC ENS@T stage II or III"Patients with preoperative diagnosis of ACC"
inclusion
inclusion · stage extent · confidence 0.70
Patients with preoperative diagnosis of ACC ENS@T stage II or III"ENS@T stage II or III"
inclusion
inclusion · prior therapy · confidence 0.85
No previous treatments for ACC except for mitotane."No previous treatments for ACC except for mitotane."
inclusion
inclusion · other · confidence 0.70
Multidisciplinary indication to upfront surgery"Multidisciplinary indication to upfront surgery"
inclusion
inclusion · pregnancy contraception · confidence 0.30
Women of child-bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study;"Women of child-bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study"
inclusion
inclusion · pregnancy contraception · confidence 0.30
Women must not be breastfeeding;"Women must not be breastfeeding"
inclusion
inclusion · logistics · confidence 0.30
Willing and able to comply with clinic visits and study-related procedures;"Willing and able to comply with clinic visits and study-related procedures"
inclusion
inclusion · consent · confidence 0.30
Willing and able to provide informed consent signed by study patient or legally acceptable representative."Willing and able to provide informed consent signed by study patient or legally acceptable representative."
exclusion
exclusion · other · confidence 0.30
Exploratory procedures or procedure conducted not according to the technical guidelines for regional adrenalectomy;"Exploratory procedures or procedure conducted not according to the technical guidelines for regional adrenalectomy"
exclusion
exclusion · condition · confidence 0.30
If the histological diagnosis after surgery will indicate a tumor histotype other than ACC, the patient will be dropped from the study."If the histological diagnosis after surgery will indicate a tumor histotype other than ACC, the patient will be dropped from the study."
exclusion
exclusion · condition · confidence 0.30
Diagnosis other than ACC at histological examination;"Diagnosis other than ACC at histological examination"
exclusion
exclusion · stage extent · confidence 0.60
Patients with ENS@T stage I or IV tumors;"Patients with ENS@T stage I or IV tumors"
exclusion
exclusion · performance status · confidence 0.97
Patients with ad ECOG performance status >1;"Patients with ad ECOG performance status >1"
exclusion
exclusion · comorbidity · confidence 0.85
Intercurrent clinical conditions, such as uncontrolled infections or heart failure, that prevent the surgical procedure from being performed"Intercurrent clinical conditions, such as uncontrolled infections or heart failure, that prevent the surgical procedure from being performed"
exclusion
exclusion · comorbidity · confidence 0.90
Patients with extensive inferior vena cava thrombosis requiring vascular replacement or extracorporeal circulation procedures;"Patients with extensive inferior vena cava thrombosis requiring vascular replacement or extracorporeal circulation procedures"
exclusion
exclusion · pregnancy contraception · confidence 0.95
Pregnancy;"Pregnancy"
exclusion
exclusion · pregnancy contraception · confidence 0.30
Continued sexual activity in women of childbearing potential or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) for at least 6 months after the HIPEC;"Continued sexual activity in women of childbearing potential or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) for at least 6 months after the HIPEC"
exclusion
exclusion · consent · confidence 0.30
Refusal to sign the informed consent;"Refusal to sign the informed consent"

Criteria extracted by claude-sonnet-5-5; 0 extracted quotes rejected for not matching the registry text.

Full eligibility text as the registry publishes it
Inclusion criteria:
1. Male and females ≥18 years of age
2. Patients with preoperative diagnosis of ACC ENS@T stage II or III
3. No previous treatments for ACC except for mitotane.
4. Multidisciplinary indication to upfront surgery
5. Women of child-bearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study;
6. Women must not be breastfeeding;
7. Willing and able to comply with clinic visits and study-related procedures;
8. Willing and able to provide informed consent signed by study patient or legally acceptable representative.

Exclusion criteria:
1. Exploratory procedures or procedure conducted not according to the technical guidelines for regional adrenalectomy;
2. If the histological diagnosis after surgery will indicate a tumor histotype other than ACC, the patient will be dropped from the study.
3. Diagnosis other than ACC at histological examination;
4. Patients with ENS@T stage I or IV tumors;
5. Patients with ad ECOG performance status >1;
6. Intercurrent clinical conditions, such as uncontrolled infections or heart failure, that prevent the surgical procedure from being performed
7. Patients with extensive inferior vena cava thrombosis requiring vascular replacement or extracorporeal circulation procedures;
8. Pregnancy;
9. Continued sexual activity in women of childbearing potential or sexually active men who are unwilling to practice highly effective contraception (including at least one highly effective contraception method, see study protocol) for at least 6 months after the HIPEC;
10. Refusal to sign the informed consent;

Routes in: how this trial is reached and paid for

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Sites (0)

The registry lists no sites. Countries: Italy.