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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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Phase 1/Phase 2 | |
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||
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|
Phase 2 | |
| Completed |
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|
N/A | |
| Completed |
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||
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Phase 2 | |
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Phase 2 | |
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Phase 1 | |
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Phase 2 | |
| Completed |
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Phase 1/Phase 2 | |
| Completed |
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Phase 2 | |
| Completed |
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Phase 2 | |
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Phase 1 | |
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Phase 1 | |
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Phase 1 | |
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Phase 2 | |
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N/A | |
| Completed |
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Phase 1 | |
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Phase 2 | |
| Completed |
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Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma
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Phase 2 |