RESUMEN
Background@#Cervical cancer is still present a major public health problem, especially in developing countries. In International Federation of Gynaecology and Obstetrics 2018, allowing assessment of retroperitoneal lymph nodes by imaging and/or pathological findings and, if deemed metastatic, the case is designated as stage IIIC (with r and p notations). Patients with lymph node metastases have lower overall survival (OS), progression free survival (PFS), and survival after recurrence, especially those who have unresectable macroscopical positive lymph nodes. Retrospective analysis suggests that there may be a benefit to debulking macroscopic nodes that would be otherwise difficult to sterilize with standard doses of radiation therapy. However, there are no prospective study reporting that resecting macroscopic nodes before concurrent chemoradiation therapy (CCRT) would improve PFS or OS of cervical cancer and no guidelines for surgical resection of bulky lymph nodes. The CQGOG0103 study is a prospective, multicenter and randomized controlled trial (RCT) evaluating lymph node dissection on stage IIICr of cervical cancer. @*Methods@#Eligible patients are histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma. Stage IIICr (confirmed by computed tomography [CT]/magnetic resonance imaging/positron emission tomography/CT) and the short diameter of image-positive lymph node ≥15 mm. 452 patients will be equally randomized to receive either CCRT (pelvic external-beam radiotherapy [EBRT]/extended-field EBRT + cisplatin [40 mg/m2] or carboplatin [the area under curve=2] every week for 5 cycles + brachytherapy) or open/minimally invasive pelvic and para-aortic lymph node dissection followed by CCRT. Randomization is stratified by status of para-aortic lymph node. The primary endpoint is PFS. Secondary endpoints are OS and surgical complications. A total of 452 patients will be enrolled from multiple hospitals in China within 4 years and followed up for 5 years.
RESUMEN
The management of patients with bulky positive lymph nodes who may not candidates for radical surgery and not response to concurrent chemoradiotherapy (CCRT) has unmet clinical need for years. Surgical excision of grossly involved pelvic or para-aortic lymph nodes has previously been suggested to provide a survival benefit. However, there are no guidelines for surgical resection of enlarged lymph nodes. We designed multicenter randomized controlled trial with 452 enrollments to evaluate lymphadenectomy in cervical cancer stage IIICr. Eligible patients are histologically confirmed cervical squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma. Stage IIICr and the short diameter of image-positive lymph node ≥15 mm. Recruited patients will be randomized to the CCRT arm, or lymphadenectomy followed by CCRT arm. For better quality control, regardless of where the enlarged lymph nodes are located, the protocol calls for the excision of para-aortic lymph nodes to the level of the inferior mesenteric artery and all the pelvic lymph nodes. The removal of such large lymph nodes is quite difficult, there are some tips for surgeons. Although the no-touch method cannot be done for these patients, but unilateral reverse exposure of blood vessels and lymph nodes suggested to be use. To avoid holding the lymph nodes and reduce the use of electric energy instruments throughout the procedure. In this way, the lymph nodes can be completely and safely cut off. So far, 65 patients have been enrolled, with 32 in CCRT group, 33 in surgery group. There was no recurrence in surgery group and 2 in CCRT group. There were no surgery-related complications and no serious adverse event till now.