Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer

NCT02125513 | Unknown Phase 2 DMC

• 2 other identifiers: GOGER-012013-002520-17
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Ovarian Cancer; Fallopian Tube Carcinoma; Peritoneal Carcinoma

Keywords

neoadjuvant chemotherapy; ovarian cancer; fallopian tube carcinoma; peritoneal carcinoma; randomized study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Percentage of patients with grade 3-5 perioperative toxicity (according to CTCAE), as a measure of safety

  within 30 days after surgery

• Percentage of patients with pathological complete response

  after surgery, up to 1 month after surgery

• Rate of 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

  from baseline to safety follow-up visit (30-34 days after surgery)

• Rate of radiological responses

  at the end of neoadjuvant chemotherapy, before surgery

Study Arms (2)

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.

Drug: carboplatin and paclitaxel followed by surgery

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.

Drug: carboplatin and paclitaxel followed by surgery

Interventions

carboplatin and paclitaxel followed by surgery DRUG

Arm A: 3 courses; Arm B: 6 courses

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• white blood cells \>3,000/µL, absolute neutrophil count ≥1,500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL,
• serum creatinine \<1.25 x upper normal limit (UNL) or creatinine clearance ≥60 mL/min according to Cockroft-Gault formula or to local lab measurement
• serum bilirubin \<1.25 x UNL, AST(SGOT) and ALT(SGPT) \<2.5 x UNL.
• Signed informed consent obtained prior to any study-specific procedures

You may not qualify if:

• Mucinous, clear cell, low-grade carcinoma and carcinosarcoma histologies.
• Synchronous or previous other malignancies within 3 years prior to starting study treatment, with the exception of adequately treated non-melanomatous skin cancer or carcinoma in situ (of the cervix or breast or other sites).
• Patients with brain metastases, seizure not controlled with standard medical therapy, or history of cerebrovascular accident (CVA, stroke) or transient ischemic attack (TIA) or subarachnoid hemorrhage within 6 months from the enrollment on this study.
• Any other concurrent medical conditions contraindicating surgery or chemotherapy that could compromise the adherence to the protocol (including but not limited to impaired cardiac function or clinically significant cardiac diseases, active or uncontrolled infections, HIV-positive patients on antiretroviral therapy, uncontrolled diabetes, cirrhosis, chronic active or persistent hepatitis, impaired respiratory function requiring oxygen-dependence,serious psychiatric disorders).
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (5)

S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Azienda Ospedaliero-Universitaria di Parma - Oncologia Medica

Parma, 43100, Italy

Location

IRCCS Ospedale Santa Maria Nuova

Reggio Emilia, Italy

Location

Fondazione Policlinico Universitario A. Gemelli

Rome, 00168, Italy

Location

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia di Udine, Reparto di Oncologia

Udine, Italy

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Claudio Zamagni, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Medical Oncologist

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 29, 2014
• Study Start: January 1, 2014
• Primary Completion: May 25, 2021
• Study Completion: December 1, 2023
• Last Updated: December 30, 2022

Record last verified: 2022-12

Locations

IT (5)