Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03275194 |
| Other study ID # |
INCAN/CI/483/15 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 2, 2017 |
| Est. completion date |
December 1, 2026 |
Study information
| Verified date |
April 2023 |
| Source |
Instituto Nacional de Cancerologia de Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Ovarian cancer is the leading cause of gynecological cancer mortality, with no current
screening method effective for early diagnosis, with 75% of advanced stage patients being
detected. Not all patients are candidates for standard treatment, which is primary
cytoreduction followed by adjuvant chemotherapy, due to the advanced process. A subgroup of
patients will receive neoadjuvant chemotherapy followed by interval surgery, which allows
higher rates of optimal cytoreduction with low morbidity and mortality. Hyperthermic
intraperitoneal chemotherapy (HIPEC) is a therapeutic option that is used in pathologies of
peritoneal dissemination, whose morbidity and mortality has been reported in several series
and is promising as a management option for ovarian cancer, so it is necessary to evaluate
morbidity and mortality that conditions this modality of treatment as well as if it impacts
on the quality of life of the patients to whom they are performed, which will allow offering
our patients an option of additional treatment to the standard.
Description:
Ovarian cancer ranks seventh in incidence of malignant neoplasms in women younger than 65
years and is the leading cause of cancer death in women in the United States. Due to the
absence of an effective screening method and early symptoms, 70% of the cases are diagnosed
in advanced clinical stage (stage III or IV) and the overall 5-year survival is 30-40%.
The standard treatment of locally advanced ovarian carcinoma is primary cytoreductive surgery
plus adjuvant chemotherapy with carboplatin and taxanes. In cases where it is not possible to
perform primary cytoreductive surgery a treatment option is to start with induction
chemotherapy (three or four cycles), in order to reduce tumor size and volume, after which it
is performed an interval surgery, during which it has been reported that optimal
cytoreduction is achieved in 77-94% of patients, with lower morbidity and mortality than
primary surgery, without oncological compromise. Subsequent to interval surgery three
additional cycles of chemotherapy are applied.
Despite an adequate response to the treatment aforementioned, 70% of patients will recur
within the first two years. Because of this high recurrence rate, other therapeutic
alternatives have been evaluated, among them is hyperthermic intraperitoneal chemotherapy
(HIPEC). Since its first description 20 years ago, the HIPEC associated with cytoreductive
surgery in the treatment of malignant neoplasms (primary or metastatic) in the peritoneal
surface has become the standard of treatment, specifically in patients with peritoneal
pseudomyxoma, peritoneal mesothelioma, and cancer with limited peritoneal involvement. In
ovarian cancer, attempts are being made to determine its usefulness in specific scenarios of
this disease.
The increasing interest in the use of HIPEC in the management of advanced ovarian cancer is
based on the coelomic dissemination of ovarian cancer, which in theory would allow this
modality of treatment to be effective. Moreover, optimal cytoreduction and administration of
intraperitoneal chemotherapy over intravenous (intraperitoneal normothermy) have been shown
to be superior in achieving higher survival rates in randomised trials.
Few groups in the world have studied the use of HIPEC in ovarian cancer, however, studies
have been (and are being conducted) in the following scenarios: a) during primary
cytoreduction, b) during interval laparotomy, c) as consolidation after standard treatment,
d) recurrence of platinum resistant carcinoma and e) in the recurrence of "platinum
sensitive" carcinoma. The morbidity of this procedure reported in different series is 33-39%,
and mortality of 0-9%. The feasibility of the procedure with low rates of morbidity and
mortality has been reported, specially when the treatment is done by a multidisciplinary
group especially trained in HIPEC.
The present project is a Phase II, randomised study whose primary objective is to evaluate
the morbidity, mortality, and quality of life of patients undergoing HIPEC during the surgery
with optimal surgical cytoreduction. One group will be treated with cytoreduction and
adjuvant chemotherapy, while the experimental group will be treated with cytoreduction
followed by HIPEC. Our secondary objectives are the assessment of the disease-free period and
overall survival. The working hypothesis is that the use of HIPEC during interval surgery
will have a morbidity considered as acceptable as reported in the literature without
significant deterioration in the quality of life.
The importance of evaluating this new therapeutic tool is that any of the current treatments
for ovarian cancer have a high rate of recurrence. Based in the evidence, biological
behaviour and pattern of dissemination of ovarian cancer, treatment should incorporate both
systemic and locoregional therapy, because the neoplasm spreads via coelomic, lymphatic and
hematogenous. The use of HIPEC together with the surgical event of cytoreduction could avoid
recurrence and allow us to distinguish those patients who are candidates for this procedure
and their actual benefit.
