Trial Information

Lymphadenectomy After Neo-Adjuvant Chemotherapy in Ovarian Neoplasm

In patients with advanced ovarian cancer (FIGO stage III-IV), a percentage between 50% and
80% had lymph node metastases at diagnosis, mainly in para-aorto-caval (48 %) and iliac
areas (49%). In 1988, FIGO has included lymph node metastasis in stage IIIC, although some
authors argue that only node involvement constitutes a clinical course different from IIIC
cancer patients with abdominal diffusion.

Although it has been demonstrated that lymphadenectomy is technically feasible and
relatively safe in this subset of patients, however, it is burdened by a certain percentage
of complications including limphocyst, lymphedema, hemorrhage, ranging from 6% to 45%. In
addition, the actual therapeutic role is still controversial and it is not clear whether
this surgical procedure should be part of the staging of these tumors. Retrospective studies
have shown a benefit on overall survival in patients with ovarian cancer who underwent
lymphadenectomy associated with optimal debulking (residual tumor <1 cm). In a recent
publication by SEER is found that the number of lymph nodes removed during surgery for
advanced ovarian cancer is an independent prognostic factor.

In the literature there is only one prospective randomized study on lymphadenectomy in
advanced ovarian cancer without node lesions macroscopically observed (bulky nodes) during
the first surgery. The authors reported a significant benefit in terms of disease free
survival (DFS), but not in terms of overall survival (OS) in patients who underwent
systematic lymphadenectomy and who had a residual tumor <1 cm. Patients with intra-abdominal
residual tumor <1 cm could theoretically not benefit from a systematic lymphadenectomy since
most of lymph node metastases undetectable to intraoperative assessment are smaller than 1
cm.

About 20% of ovarian cancer patients stage III-IV, however, are not operable at the time of
diagnosis because of the spread of the disease. In these cases, the gold standard treatment
consists of submitting the patient to Interval Debulking Surgery (IDS) after neoadjuvant
chemotherapy. The prognosis of these patients compared to those who are subjected to primary
surgery, with the same residual tumor after surgery, is currently a topic of controversial
debate. Recently, a multicenter, randomized EORTC showed no difference in prognosis between
primary surgery and Interval Debulking Surgery in a population stratified by residual tumor.
There are few retrospective studies that consider the presence of lymph node metastases in
patients undergoing Interval Debulking Surgery: the percentage of lymph node metastases in
this subset varies from 37.5% to 75%.

The purpose of the study is to assess whether systematic pelvic and aortic lymphadenectomy
should be part of standard surgical procedures in patients with ovarian cancer who underwent
surgery after neoadjuvant chemotherapy with intra-abdominal residual tumor <1 cm.

All patients candidate for Interval Debulking Surgery which do not present bulky nodes at
surgery and which have an intra-abdominal residual tumor <1 cm at the end of the surgery
will be enrolled in the study.

The baseline assessment of patients is to perform general blood tests, CA 125, CT thorax,
abdomen, pelvis, anesthetic assessment and, if eligible, the patients will be subjected to
the treatment above.

The enrollment period will last for 2 years until the achieving of 65 patients as the study
population. The median follow-up of 6 months for all patients for the primary objectives and
a median of 36 months for the secondary objectives.