Fallopian Tube Cancer Clinical Trial
Official title:
Multi-center, Randomized Controlled, Phase III Trials to Evaluate the Safety and Effectiveness After Cycles Reduction of Neoadjuvant Chemotherapy for Advanced Epithelial Ovarian, Fallopian and Primary Peritoneal Cancer
Te hypothesized that two cycles of neoadjuvant chemotherapy followed by interval debulking
surgery would improve survival in advanced epithelial ovarian, fallopian, and primary
peritoneal cancer because reduction of one cycle of chemotherapy can lead to the removal of
more tumor burden, compared with three cycles of neoadjuvant chemotherapy.
So the investigators aim to compare survival, rate of successful optimal cytoreductive
surgery, post-operative complications, and quality of life between two and three cycles of
neoadjuvant chemotherapy followed by interval debulking surgery for advanced epithelial
ovarian, fallopian, and primary peritoneal cancer.
Primary debulking surgery (PDS) followed by adjuvant chemotherapy is the standard treatment
for advanced epithelial ovarian, fallopian and primary peritoneal cancer. However, three or
four cycles of neoadjuvant chemotherapy (NAC) followed by interval debulking surgery (IDS)
has been introduced in clinical setting because four randomized controlled trials related
have shown a lower rate of complications in NAC followed by IDS despite the similar efficacy
between PDS and NAC followed by IDS in advanced epithelial ovarian, fallopian and primary
peritoneal cancers. However, these trials have some limitations that the rate of optimal
cytoreduction defined as the size of residual tumor <1 cm was about 40%, which was a
disappointed result not showing the surgical effect improving survival. Nevertheless, more
treatment strategies using NAC followed by IDS should be investigated because NAC followed by
IDS has been already known as another standard treatment due to the safety.
A recent meta-analysis has reported that reduction of one cycle of neoadjuvant chemotherapy
may increase overall survival of 4.1 months because it can induce surgical resection of more
visible tumors with drug-resistant. Moreover, a related clinical trial has shown that
hyperthermic intraperitoneal chemotherapy (HIPEC) may increase survival in patients with
advanced ovarian cancer who received three cycles of neoadjuvant chemotherapy because HIPEC
can kill drug-resistant invisible tumor cells which were not resected during IDS. Thus, the
investigators designed a phase 3, multicenter, randomized controlled trial for comparing
survival, clinical outcomes and quality of life between two and three cycles of NAC followed
by IDS, and thereby will investigate the efficacy and safety of reduction of one cycle of
NAC.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03393884 -
Study of IMNN-001 (Also Known as GEN-1) With NACT for Treatment of Ovarian Cancer (OVATION 2)
|
Phase 1/Phase 2 | |
| Completed |
NCT04546373 -
Niraparib as Maintenance Therapy in Patients With Platinum Sensitive Recurrent Ovarian Cancer
|
||
| Active, not recruiting |
NCT05456685 -
IMGN853 With Carboplatin in Second-line Treatment of FRα Expressing, Platinum-sensitive Epithelial Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT01442051 -
Acute Normovolemic Hemodilution in Patients Undergoing Cytoreductive Surgery for Advanced Ovarian Cancer
|
N/A | |
| Completed |
NCT02928549 -
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study
|
||
| Active, not recruiting |
NCT03648489 -
Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)
|
Phase 2 | |
| Not yet recruiting |
NCT04983550 -
Efficacy and Safety of SG001 Combined With PLD in Patients With Platinum-resistant Relapsed EOC
|
Phase 2 | |
| Completed |
NCT02480374 -
Study of Safety & Biological Activity of IP IMNN-001 (Also Known as GEN-1) With Neoadjuvant Chemo in Ovarian Cancer
|
Phase 1 | |
| Completed |
NCT01899599 -
PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT01610206 -
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
|
Phase 2 | |
| Completed |
NCT03480750 -
Trial of Trientine Plus Pegylated Liposomal Doxorubicin and Carboplatin in Epithelial Ovarian Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT01219777 -
Neoadjuvant Chemotherapy IV Carboplatin With Weekly Paclitaxel \Bevacizumab for Primary Ovarian
|
Phase 1 | |
| Completed |
NCT01031381 -
Study of RAD001 and Bevacizumab in Recurrent Ovarian, Peritoneal, and Fallopian Tube Cancer
|
Phase 2 | |
| Completed |
NCT00959582 -
Positron Emission Tomography/Computed Tomography (PET/CT) in Relapsed Ovarian Cancer (MK-0000-143)
|
Phase 1 | |
| Suspended |
NCT00753480 -
A Study of D4064A Administered to Patients With Recurrent or Persistent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
|
Phase 1 | |
| Completed |
NCT00801320 -
Primary Tumor Harvest for the Purpose of Possible Use in a Future Clinical Trial in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer
|
N/A | |
| Completed |
NCT00768144 -
Sunitinib in Recurrent and Refractory Ovarian, Fallopian Tube and Peritoneal Carcinoma
|
Phase 2 | |
| Completed |
NCT00702299 -
Alimta® Plus Cisplatin & Paclitaxel Given Intraperitonelly; First Line Tx Stage III Ovarian Cancer
|
Phase 1 | |
| Recruiting |
NCT02349958 -
Clinical Trial of Intraperitoneal Hyperthermic Chemotherapy
|
Phase 2 | |
| Completed |
NCT00390234 -
Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
|
Phase 2 |