Cervical Cancer, Uterine Cancer
Conditions
Keywords
Ontogenetic surgery, TMMR, PMMR, LEER
Brief summary
The purpose of this study is to compare standard treatment and fusion ontogenetic surgery (total mesometrial resection, laterally extended endopelvic resection, peritoneal mesometrial resection) for gynecologic cancer in order to evaluate treatment response, adverse effect and survival.
Detailed description
Fujii method and ontogenetic surgery are the surgical method of radical hysterectomy that can preserve pelvic organ function as much as possible. Fujii method has advantage of preserving pelvic autonomic nerve with radical resection of tissue under parametrium. And ontogenetic surgery has advantage of reducing need of radiation therapy by radical resection of tissue above parametrium. This study is prospective study for fusion ontogenetic surgery that has the advantage of both Fujji method and ontogenetic surgery.
Interventions
PROCEDUREUterine cancer
Perform Fusion Peritoneal mesometrial resection (PMMR). After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. If not, no adjuvant therapy.
PROCEDURECervical cancer
If tumor sized ≥ 5cm, undergo neoadjuvant chemotherapy with Cisplatin before surgery. (40mg/m2 on day 1 of each 7 day cycle for 5 cycles), then perform Fusion TMMR after neoadjuvant chemotherapy with cisplatin as above. If tumor size \< 5cm, perform Fusion Total mesometrial resection (TMMR) After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. If not, no adjuvant therapy.
PROCEDURECervical cancer, pelvic sidewall invasion
Perform Fusion Laterally extended endopelvic resection (LEER). After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. Patients with primary disease will be treated with adjvuant chemotherapy. In case of recurrent disease, bevacizumab, paclitaxel, and cisplaitn will be administered regardless of the pathologic report (bevacizumab 15mg/kg on day 1, paclitaxel 135mg/m2 on day 1, and cisplatin 50mg/m2 on day 2, of each 21 day cycle). If not, no adjuvant therapy.
PROCEDURENon-cervical cancer, pelvic sidewall invasion
Perform Fusion Laterally extended endopelvic resection (LEER). After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type.
Sponsors
Seoul National University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female, Age ≥ 20 years * Patients with primary, recurrent, or refractory cervical cancer (FIGO stage IB1-IVA), primary, recurrent, or refractory uterine cancer (FIGO stage IA, grade 3, IB-IVA), or gynecologic cancer patients showing pelvic sidewall recurrence. * ECOG performance status 0 or 1 * Extensive surgery might be expected to cure the disease, or expected to relieve severe pelvic pain. * Patients who signed an approved informed consent * Patients who do not have a treatment option other than surgery.
Exclusion criteria
* Female, Age \< 20 years * ECOG performance status ≥2 * Bilateral pelvic sidewall invasion * Patients who had undergone radical hysterectomy, trachelectomy, or hysterectomy in case of the primary disease. * Patients who refused to sign an informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From date of treatment start until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months | The time interval from treatment start date to disease recurrence or progression date |
| Overall survival | From the date of treatment start until death due to any cause, assessed up to 60 months | the time interval from treatment start date to death or end of study date |
| Treatment-free interval | From date of treatment end until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 60 months | The time interval from treatment end date to disease recurrence or progression date |
| Treatment-related survival | the time interval from treatment start date to death or end of study date assessed up to 60 months | the time interval from treatment start date to death or end of study date (recurrent or refractory disease) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications 2 | 31 days after the ontogenetic surgery through study completion, an average of 1 year | Incidence of late complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System |
| Neurologic disturbance of low extremity | after the ontogenetic surgery, up to 30 days | Incidence of motor and sensory disturbances of low extremities, and the grading is based on Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Time to normal bladder function | The time from the ontogentic surgery to the time of confirmation or normal bladder function, assessed up to 60 months | In case of bladder preservation, normal bladder function is evaluated by residual urine check after time voiding, and the volume of residual urine is less than 100cc. The time from the ontogentic surgery to the time of confirmation or normal bladder function. |
| Pain evaluation | 1 day before the ontogenetic surgery, and at the time of discharge after postoperative management of the ontogenetic surgery assessed up to 60 months | Pelvic pain evaluated by numeric rating scale and morphine milligram equivalents (MME) |
| Tumor response | 3 weeks after completion of ontogenetic surgery up to 6 weeks | Tumor response after surgery, and the evaluation is based on revised RECIST version 1.1 |
| Postoperative complications 1 | after the ontogenetic surgery, up to 30 days | Incidence of early complications, and severity of complications based on Memorial Sloan Kettering Cancer Center Surgical Secondary Events Grading System |
Countries
South Korea
Contacts
Primary ContactHee Seung Kim, MD
Outcome results
None listed