Cervical Cancer Clinical Trial
Official title:
A Randomized Phase III Trial for Evaluation of Usefulness of Pelvic Drains After Radical Hysterectomy and Node Dissection (RHND)
RATIONALE: The use of pelvic drains may help to prevent complications following radical
hysterectomy and pelvic lymphadenectomy. It is not known whether receiving pelvic drains
during surgery is more effective than receiving no pelvic drains during surgery in patients
with uterine, cervical, or vaginal cancer.
PURPOSE: Randomized phase III trial to determine if the use of pelvic drains following
radical hysterectomy and pelvic lymphadenectomy is effective in treating patients with
uterine, cervical, or vaginal cancer.
OBJECTIVES: I. Evaluate postoperative complications associated with the use or omission of
pelvic drains following radical hysterectomy and node dissection that includes suturing of
the vaginal cuff and no peritonealization.
OUTLINE: This is a randomized, two-arm study. All patients receive radical hysterectomy
(Rutledge-Piver II-III type) and pelvic lymphadenectomy, without pelvic and parietal
peritonealization, with suturing of the vaginal cuff and closure of fascia and cutaneous
layers; lumboaortic node dissection is optional. Patients are randomized during surgery to
one of two arms: those on arm I receive pelvic drains and those on arm II do not. Those in
arm I have drains applied in the pelvis, and lymph is collected by vaginal and/or
transabdominal drains located in both retroperitoneal fossa. Drains are removed when the
loss is less than 50 mL in 24 hours. Patients in both arms are followed at 2-3 months and 12
months after surgery.
PROJECTED ACCRUAL: 214 patients will be accrued for this study within 2 years.
;
Allocation: Randomized, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT06223308 -
A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Terminated |
NCT03367871 -
Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04537156 -
Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli)
|
Phase 3 | |
| Recruiting |
NCT03668639 -
Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
| Withdrawn |
NCT04806945 -
A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer
|
Phase 3 | |
| Active, not recruiting |
NCT04185389 -
Long-Term Follow-Up of HPV FOCAL Participants
|
||
| Withdrawn |
NCT03007771 -
Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia
|
Phase 1 | |
| Completed |
NCT03384511 -
The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies.
|
Phase 4 | |
| Recruiting |
NCT05107674 -
A Study of NX-1607 in Adults With Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT05120167 -
Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy
|
N/A | |
| Recruiting |
NCT05483491 -
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
|
Phase 1 | |
| Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
| Completed |
NCT05862844 -
Promise Women Project
|
N/A | |
| Recruiting |
NCT04934982 -
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)
|
N/A | |
| Recruiting |
NCT03876860 -
An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis
|
N/A | |
| Completed |
NCT03652077 -
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
|
Phase 1 | |
| Completed |
NCT00543543 -
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
|
Phase 3 | |
| Terminated |
NCT04864782 -
QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04226313 -
Self-sampling for Non-attenders to Cervical Cancer Screening
|
N/A |