Pretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer.

Pretherapeutic para-aortic lymphadenectomy in advanced stage cervical cancer. - PALDISC

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40720

Enrollment

Registered

2014-07-29

Start date

2015-07-03

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer metastases metastatic cancer of the cervix

Interventions

Para-aortic lymphadenectomy will be added to standard of care and imaging (CT, MRI and/or Pet-CT) for locally advanced cervical cancer.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age * 18 years Histologically confirmed squamous cell, adenosquamous or adenocarcinoma of the cervix Stage IB2 , IIA with tumor > 4cm,IIB, IIIA, IIIB, IVA, staging performed as examination under anesthesia (EUA). WHO-performance 0-2 No evidence of distant metastasis Fit for surgery Written informed consent

Exclusion criteria

Exclusion criteria: Previous malignancy (except for non-melanoma skin cancer) Prior retroperitoneal surgery Previous pelvic or abdominal radiotherapy Upper abdominal intraperitoneal disease or evidence of ovarian metastasis Evidence of distant metastasis on imaging or physical examination Bulky para-aortic lymph nodes > 2cm Pregnancy Otherwise unfit for surgery

Design outcomes

Primary

Measure	Time frame
The main study parameter is the safety and feasibility of para-aortic surgical staging. This will be assessed by registering proportion of included patients amongst all eligible patients. Furthermore by registering duration of surgical procedure, blood loss, complications and adverse events. Nodal yield will be compared to results found in other studies in order to assess completeness of lymphadenectomy.	—

Measure

Time frame

The main study parameter is the safety and feasibility of para-aortic surgical staging. This will be assessed by registering proportion of included patients amongst all eligible patients. Furthermore by registering duration of surgical procedure, blood loss, complications and adverse events. Nodal yield will be compared to results found in other studies in order to assess completeness of lymphadenectomy.

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Secondary

Measure	Time frame
Data on sensitivity, specificity, negative and positive predictive value of MRI, PET-CT and surgical staging will be gathered to base power calculations for a future independent phase 3 trial. The amount and diameter of metastases and proportion of modified initial treatment plans for adjuvant therapy, due to histological findings will be documented. Morbidity and mortality, Quality of life (QLQ-C30 version 3.0, QLQ-CX24) and progression-free and overall survival during the first year after surgery will be compared between treatment arms. Treatment delay due to surgical intervention and histological analyses will be compared. Time to treatment will be measured from the day of randomization until start of chemo radiation.	—

Measure

Time frame

Data on sensitivity, specificity, negative and positive predictive value of MRI, PET-CT and surgical staging will be gathered to base power calculations for a future independent phase 3 trial. The amount and diameter of metastases and proportion of modified initial treatment plans for adjuvant therapy, due to histological findings will be documented. Morbidity and mortality, Quality of life (QLQ-C30 version 3.0, QLQ-CX24) and progression-free and overall survival during the first year after surgery will be compared between treatment arms. Treatment delay due to surgical intervention and histological analyses will be compared. Time to treatment will be measured from the day of randomization until start of chemo radiation.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)