Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr

Study Overview
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Brief Summary
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This study is a prospective, multicenter and randomized clinical trial (DEBULK trial) to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) in cervical cancer stage IIICr.

Detailed Description
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Bulky or multiple lymph nodes metastasis in cervical cancer shows poor prognosis and can also diminish the effect of radiotherapy or concurrent chemoradiation therapy (CCRT). However, it is difficult to increase the dose of radiation and chemotherapy considering their side effects. Therefore, the objective of this study is to determine the therapeutic effect of surgical debulking of bulky or multiple lymph nodes before concurrent chemoradiation therapy (CCRT) compared to CCRT only, in cervical cancer stage IIICr. This study is a phase III, multicenter and randomized clinical trial (DEBULK trial). Concurrent chemoradiation therapy (CCRT) Surgical debulking of bulky or multiple lymph node followed by CCRT

Official Title
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Therapeutic Effect of Surgical Debulking of Metastatic Lymph Nodes in Cervical Cancer Stage IIICr: A Phase III, Randomized Controlled Clinical Trial

Conditions
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Cervical Cancer

Intervention / Treatment
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* Radiation: CCRT
* Procedure: Surgical debulking of bulky or multiple lymph nodes
* Radiation: CCRT


Participation Criteria
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Eligibility Criteria
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1) Inclusion Criteria Women ≥20 years and ≤ 70 years of age Cervical histopathology results of newly diagnosed squamous cell carcinoma, glandular epithelial cell, or adenosquamous carcinoma When the radiology examinations such as CT, MRI, or PET-CT show the short-axis of the pelvic lymph node or paraaortic lymph node under the renal vein is ≥ 2cm, or more than 3 lymph nodes with a short axis ≥ 1 cm When concurrent chemoradiation therapy is planned as a treatment for cervical cancer Patient whose competency is ECOG performance score 0-1 A patient which has signed the approved informed consent form for study subjects A patient for which it is determined that pre-surgical debulking is possible for lymph node metastasis as confirmed by radiological examination 2) Exclusion Criteria A patient who has been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years A patient that is pregnant or plans to become pregnant during the clinical study period A patient with any active infectious disease or incurable severe inflammation. When surgery is not possible due to internal or surgical disease When chemotherapy is impossible due to internal or surgical disease Patient with a history of pelvic radiation therapy Patient with a history of subtotal hysterectomy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>Concurrent chemoradiation therapy (CCRT) | Radiation: CCRT<br>* Radiation: Extended field-external beam radiation therapy (EF-EBRT) + brachytherapy + lymph node boost. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles. Radiation and chemotherapy are administered concurrently.<br>|
| Experimental: Experimental group<br>Surgical debulking of bulky or multiple lymph node followed by CCRT | Procedure: Surgical debulking of bulky or multiple lymph nodes<br>* Open/minimally invasive method. Surgical debulking of bulky or multiple lymph nodes. Postoperative imaging evaluation to determine whether the lymph node has been successfully removed.<br>Radiation: CCRT<br>* Radiation: EBRT/EF-EBRT + brachytherapy + lymph node boost. Chemotherapy: Cisplatin 40mg/m2, every week, 4 to 6 cycles. Radiation and chemotherapy are administered concurrently.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 3 years | 
| Treatment-related complications | Treatment-related complications | 3 years | 
| False positive rate & positive predictive value of bulky or multiple LN imaging | To determine the accuracy of LN metastasis in imaging study | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical cancer IIICr, Bulky or multiple lymph nodes, Surgical debulking of lymph nodes, Concurrent chemoradiation therapy