Cervical Cancer
Conditions
Keywords
Cervical cancer IIICr, Bulky or multiple lymph nodes, Surgical debulking of lymph nodes, Concurrent chemoradiation therapy
Brief summary
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
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
Interventions
OTHERCCRT
CCRT
PROCEDURESurgical debulking of lymph nodes + CCRT
Surgical debulking of lymph nodes + CCRT
Sponsors
Korean Gynecologic Oncology Group
CHA University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1\) Inclusion Criteria (1) Women aged ≥ 20 years and ≤ 70 years (2) Patients newly diagnosed with squamous cell carcinoma (SCC), adenocarcinoma, or adenosquamous carcinoma (3) Patients with a short-axis diameter of the pelvic LN or para-aortic LN under the renal vein of ≥ 1.5 cm or ≥ 2 LNs with a short-axis diameter ≥ 1 cm in CT or MRI (PET-CT can be used as an auxiliary tool) (4) Patients with CCRT planned as a treatment for cervical cancer (5) Patients whose competency is Eastern Cooperative Oncology Group performance score 0-1 (6) Patients who have signed the approved informed consent form for study participants (7) Patients in whom surgical debulking for LN metastasis was possible, as confirmed by radiological examination. 2\)
Exclusion criteria
(1) Patients who have been diagnosed with cancer of any organ other than thyroid cancer (excluding stage 0 cancer) within the previous 5 years (2) Patients who are pregnant or plans to conceive during the clinical study period (3) Patients with any active infectious disease or incurable severe inflammation (4) Patients who cannot undergo surgery due to internal or surgical disease (5) Patients who cannot receive chemotherapy due to internal or surgical disease (6) Patients with a history of pelvic RT (7) Patients with a history of subtotal hysterectomy (8) Patients with remote metastasis other than a pelvic or para-aortic LN (e.g., lung, subclavian, and inguinal LNs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 years | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 3 years | Overall survival |
| Treatment-related complications | 3 years | Treatment-related complications |
| False positive rate & positive predictive value of bulky or multiple LN imaging | 6 months | To determine the accuracy of LN metastasis in imaging study |
Countries
India, Italy, Romania, South Korea, Vietnam
Contacts
Primary ContactJu-Won Roh
Outcome results
None listed