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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002520-17 | EudraCT Number |
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The purpose of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: 3 courses | Active Comparator | Patients will receive 3 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks, followed by cytoreductive surgery within 6 weeks from the last cycle of chemotherapy. Alternatively, the Participating Centres can use the weekly paclitaxel schedule: carboplatin AUC 6 day 1 and paclitaxel 80 mg/m2 day 1-8-15. |
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| Arm B: 6 courses | Experimental | Patients will receive 6 courses of i.v. carboplatin AUC 5 and paclitaxel 175 mg/m2 every 3 weeks, followed by cytoreductive surgery within 6 weeks from the last cycle of chemotherapy. Alternatively, the Participating Centres can use the weekly paclitaxel schedule: carboplatin AUC 6 day 1 and paclitaxel 80 mg/m2 day 1-8-15. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| carboplatin and paclitaxel followed by surgery | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who obtain a complete cytoreduction (no macroscopic residual tumor) at surgery , as a comparative outcome measure of 3 vs 6 courses of neoadjuvant chemotherapy | The primary objective of this study is to define whether 6 courses of neoadjuvant chemotherapy can lead to a higher rate of complete cytoreductive surgery compared with 3 courses of neoadjuvant chemotherapy in patients with bulky stage IIIC or IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer | within 6 weeks after the last cycle of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with grade 3-5 perioperative toxicity (according to CTCAE), as a measure of safety | To determine whether a longer duration of neoadjuvant chemotherapy is associated with a lower rate of perioperative grade 3-5 toxicities. The surgical adverse events are defined as:
Adverse events list for surgical procedures: Postoperative death (<30 days); Hemorrhage/bleeding intraoperative or postoperative requiring at least transfusion of 2 units of non-autologous red blood cells; Vascular events: thrombosis/embolism, disabling or life-threatening vessel injury-artery or vein, symptomatic or life-threatening visceral arterial ischemia; Infections requiring IV antibiotics, antifungal or antiviral interventions or at risk for life-threatening consequences; Gastrointestinal fistula; Urinary fistula; Lymphocele, requiring medical or operative intervention. |
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Inclusion Criteria:
Female patients ≥18 years.
Karnofsky Performance Scale ≥ 60%
Histologically confirmed epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal carcinoma with the exception of mucinous, clear cell, low-grade carcinoma and carcinosarcoma histologies.
Documented International Federation of Gynecologic Oncology (FIGO) stage IIIC-IV oligometastatic unsuitable for complete primary cytoreductive surgery. Inoperability must be confirmed by open laparoscopy or by laparotomy.
Adequate bone marrow, liver and renal function to receive chemotherapy and subsequently to undergo surgery:
Signed informed consent obtained prior to any study-specific procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Zamagni, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.Orsola-Malpighi Hospital | Bologna | 40138 | Italy | |||
| Azienda Ospedaliero-Universitaria di Parma - Oncologia Medica |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| within 30 days after surgery |
| Percentage of patients with pathological complete response | To determine whether a longer duration of neoadjuvant chemotherapy is associated with higher rate of pathological complete response. Complete pathological response is defined as the absence of cancer cells in surgical specimens, and very good partial remission is defined as the persistence of only small clusters (< 1 cm) or individual cancer cells and no macroscopic residual after surgery. Partial pathological remission is defined as a tumor burden reduction between 30 and 90% at surgery, while stable disease is defined as no tumour burden reduction or reduction lower than 30% at surgery, compared with initial diagnostic laparoscopy. Only patients with complete and very good partial remissions are considered as pathological responders, while all the other cases are considered as pathological non-responders. | after surgery, up to 1 month after surgery |
| Rate of progression-free survival | To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer progression-free survival. | from date of randomization until the date of disease progression or second cancer or death from any cause, whichever occurs first, assessed for 10 years after the end of chemotherapy |
| Health related quality of life | To compare the quality of life in the two treatment groups | from baseline to safety follow-up visit (30-34 days after surgery) |
| Rate of radiological responses | To determine whether a longer duration of neoadjuvant chemotherapy is associated with a higher rate of radiological responses (according to RECIST 1.1 criteria). | at the end of neoadjuvant chemotherapy, before surgery |
| Rate of decrease of CA125 levels during NACT | To determine whether a longer duration of neoadjuvant chemotherapy is associated with a greater decrease of CA125 levels. | from cycle 1 of chemotherapy to safety follow-up visit (30-34 days after surgery) |
| Rate of overall survival | To determine whether a longer duration of neoadjuvant chemotherapy is associated with longer overall survival. | from date of randomization until date of death due to any cause, assessed until 10 years after the end of chemotherapy |
| Parma |
| 43100 |
| Italy |
| IRCCS Ospedale Santa Maria Nuova | Reggio Emilia | Italy |
| Fondazione Policlinico Universitario A. Gemelli | Rome | 00168 | Italy |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia | Udine | Italy |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |