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Esiti dopo chirurgia citoriduttiva secondaria con o senza chemioterapia ipertermica intraperitoneale con carboplatino (HIPEC) seguita da chemioterapia sistemica di combinazione per carcinoma ovarico sensibile al platino ricorrente, tuba di Falloppio o carcinoma peritoneale primario

10 settembre 2026 aggiornato da: Memorial Sloan Kettering Cancer Center

Uno studio randomizzato di fase II: risultati dopo chirurgia citoriduttiva secondaria con o senza chemioterapia intraperitoneale ipertermica con carboplatino (HIPEC) seguita da chemioterapia di combinazione sistemica per carcinoma ovarico sensibile al platino ricorrente, tuba di Falloppio o carcinoma peritoneale primario

The purpose of this study is to see if the investigators can improve the treatment of this type of cancer. They want to find out what effects, good and/or bad, giving heated chemotherapy into the belly, known as hyperthermic intraperitoneal chemotherapy (HIPEC), has on the patient and this type of cancer.

The goal of HIPEC is to expose any cancer left in the abdomen after surgery to high doses of chemotherapy. The chemotherapy is heated in the hope that this will make it easier for it to get into and kill the cancer cells. The drug used for HIPEC will be carboplatin, a Food and Drug Administration (FDA) approved drug for use in ovarian, fallopian tube or primary peritoneal cancer.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

99

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Connecticut
      • Hartford, Connecticut, Stati Uniti, 06102
        • Hartford Healthcare Cancer Institute @ Hartford Hospital
    • Florida
      • Miami, Florida, Stati Uniti, 33143
        • Baptist Health South Florida
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • University of Chicago Medical Center
    • Minnesota
      • Rochester, Minnesota, Stati Uniti, 55905
        • Mayo Clinic
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti
        • Memorial Sloan Kettering Basking Ridge
      • Middletown, New Jersey, Stati Uniti, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Stati Uniti, 07645
        • Memorial Sloan Kettering Bergen
    • New York
      • Commack, New York, Stati Uniti, 11725
        • Memorial Sloan Kettering Commack
      • Harrison, New York, Stati Uniti, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, Stati Uniti, 10065
        • Memorial Sloan Kettering Cancer Center
      • Uniondale, New York, Stati Uniti, 11553
        • Memorial Sloan Kettering Nassau (All protocol activities, except surgery)

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

Inclusion Criteria for Eligibility Prior to Surgery:

  • Age ≥ 21 years old.
  • Patients with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal carcinoma, or fallopian tube carcinoma that has recurred >6 months since platinum-based chemotherapy (first recurrence) and who are scheduled for secondary surgical evaluation/cytoreduction.
  • Histologic epithelial cell types include serous, endometrioid, clear cell, or undifferentiated carcinomas, transitional cell carcinoma, mixed epithelial carcinoma, malignant Brenner's tumor, or adenocarcinoma N.O.S.
  • Karnofsky Performance Status (KPS) of ≥ 70%.
  • Disease-free interval ≤ 30 months.
  • No prior chemotherapy in the recurrent setting. Prior hormonal therapy is permitted. Concomitant anti-neoplastic anti-hormonal therapy (including tamoxifen, aromatase inhibitors etc.) is not allowed for patients participating in study treatment. Low-dose (physiologic) estrogen hormone-replacement therapy (HRT) may be given.
  • Patients receiving maintenance biologic therapy are eligible, provided their recurrence is documented more than 6 months from completion of primary cytotoxic chemotherapy (includes maintenance chemotherapy) and a minimum of 3 weeks has elapsed since their last infusion of biologic therapy at the start of protocol intervention, day 1.
  • Patients must be, after evaluation by the investigator, appropriate candidates for the administration of 5 to 6 cycles of standard platinum-based combination chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, or carboplatin and gemcitabine) following CRS with or without HIPEC.
  • Bone marrow function:
  • Hemoglobin ≥ 8.5 g/dL.
  • Absolute neutrophil count (ANC) ≥ 1,000/mm3.
  • Platelets ≥ 100,000/mm3.
  • Renal function:
  • Creatinine ≤ 1.5mg/dl
  • Hepatic function:
  • Bilirubin ≤ 1.5 times ULN.
  • ALT ≤ 3 times the ULN.
  • AST ≤ 3 times the ULN.
  • Neurologic function:
  • Peripheral neuropathy ≤ CTC AE grade 2.
  • Blood coagulation parameters:
  • PT with an INR of ≤ 1.5 and a PTT ≤ 1.5 times the ULN. For patients on full-dose oral anti-coagulation (such as warfarin or rivaroxaban), in-range INR (usually between 2 and 3) and a PTT <1.2 times the ULN.
  • Patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to CRS and must be practicing an effective form of contraception during the study period.

Inclusion Criteria for Eligibility Post-Surgery:

  • Patients will be consented prior to the surgical evaluation/cytoreductive surgery. Patients must have less than or equal to 0.5cm residual disease at the completion of the secondary surgery to be eligible for the study.

Exclusion Criteria:

Exclusion Criteria for Eligibility Prior to Surgery:

  • Tumors of low malignant potential (borderline carcinomas).
  • Subjects who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded.
  • Patients with a history of primary endometrial cancer are excluded unless the following conditions are met:
  • Stage not greater than IA.
  • Not a poorly differentiated subtype (including papillary serous, clear cell or other FIGO grade 3 lesions)
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies, who had any evidence of the other cancer present within the last 1 year or whose previous cancer treatment contraindicates this protocol therapy, are excluded.
  • Subjects with known active acute hepatitis.
  • Subjects with active infection that requires parenteral antibiotics.
  • Active coronary artery disease (defined as unstable angina or a positive cardiac stress test).
  • Patients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment.
  • Uncontrolled hypertension defined as > 140/90 and not cleared for surgery at the time of consent..
  • New York Heart Association (NYHA) Class II or higher Congestive heart failure.
  • History of cerebrovascular disease.
  • Immune deficiency: Clinically significant primary or acquired immune deficiency (i.e. AIDS or on immunosuppressive medication after organ transplant).
  • Patients with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study.
  • Patients with known carboplatin or cisplatin allergy.
  • Life expectancy < 12 weeks.

Exclusion Criteria for Eligibility Post-Surgery:

  • Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operating surgeon which prohibits intraperitoneal therapy.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Secondary Cytoreductive Surgery with HIPEC

secondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B). In some patients randomized to HIPEC at MSKCC only , peritoneal fluid and blood samples will be drawn before, during and after the HIPEC procedure.

5 cycles

6 cycles

Sperimentale: Secondary Cytoreductive Surgery without HIPEC

secondary cytoreductive surgery (CRS) with or without carboplatin-based hyperthermic intraperitoneal chemotherapy (HIPEC) followed by systemic combination chemotherapy for recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer. Patients will be randomized intraoperatively to undergo CRS with HIPEC (arm A) or CRS only (arm B) in a manner 1:1. Both arms will receive a standard platinum-based systemic chemotherapy postoperatively (5 cycles in arm A and 6 cycles in arm B).

5 cycles

6 cycles

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression Free Survival
Lasso di tempo: up to 4 years

A proportion of patients ≥ 40%, who are without evidence of disease progression at 24 months, is considered acceptable, whereas a proportion of ≤ 25% is considered not acceptable in this patient population.

up to 4 years

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants Evaluated for Toxicity
Lasso di tempo: 4 weeks post op

Study participants will be evaluated for toxicity with the NCI Common Terminology Criteria for Adverse Events version 4.0. and MSKCC Surgical Secondary Events Grading System for complications.

4 weeks post op
Determine the Completion Rate of Four Cycles
Lasso di tempo: 5 years

A secondary analysis of estimating the completion rate will be conducted. The completion rate and a 95% confidence interval will be calculated for each arm separately. Completion is defined as patients being able to complete ≥ 4 out of 5 or 6 cycles of a standard systemic chemotherapy.

5 years
Pharmacokinetics for HIPEC Arm Only
Lasso di tempo: 5 years

in a subset of patients randomized to receive HIPEC in the OR. In patients randomized to HIPEC, peritoneal fluid and blood samples only from MSKCC patients will be drawn before, during and after the HIPEC procedure.

5 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Collaboratori

Investigatori

  • Investigatore principale: Dennis Chi, MD, Memorial Sloan Kettering Cancer Center

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

8 gennaio 2013

Completamento primario (Effettivo)

26 agosto 2025

Completamento dello studio (Effettivo)

26 agosto 2025

Date di iscrizione allo studio

Primo inviato

10 gennaio 2013

Primo inviato che soddisfa i criteri di controllo qualità

10 gennaio 2013

Primo Inserito (Stimato)

14 gennaio 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 agosto 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 12-275

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .