Short-course HIPEC in Advanced Epithelial Ovarian Cancer
Short-course Hyperthermic IntraPEritoneal Chemotherapy (HIPEC) at Interval Debulking Surgery for High Tumor Burden Ovarian Cancer
2 other identifiers
interventional
15
0 countries
N/A
Brief Summary
This is an open-label, multicenter, single-arm, feasibility phase 2 trial on safety and efficacy of short-course regimen of intra-operative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) at the time of fast-track interval debulking surgery (IDS) following neoadjuvant chemotherapy (NACT) for high tumor burden epithelial ovarian cancer (EOC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 ovarian-cancer
Started Feb 2015
Longer than P75 for phase_2 ovarian-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2014
CompletedFirst Posted
Study publicly available on registry
September 25, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2021
CompletedMarch 18, 2021
March 1, 2021
6.1 years
September 22, 2014
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PD9
Proportion of patients with disease progression or death occurring within 9 months of IDS plus HIPEC
9 months
Secondary Outcomes (6)
Postoperative 30-day mortality rate
30 days
Postoperative complication rates
30 days
Assessment of quality of life (QLQ-C30/EORTC)
Baseline (i.e., at the time of hospital admission for IDS plus HIPEC); after CRS/HIPEC (i.e., at the time of restarting the systemic chemotherapy); after protocol (i.e., at 3-6 weeks after the last syst
Overall survival (OS)
24 months
Progression-free Survival (PFS)
24 months
- +1 more secondary outcomes
Other Outcomes (2)
Time to start chemotherapy after surgery
An expected range of 4 to 8 weeks
Length of ICU and hospital stay
An expected range of 5 to 30 days
Study Arms (1)
HIPEC
EXPERIMENTALNeoadjuvant Chemotherapy (NACT) followed by Cytoreductive Surgery (CRS) under a Fast-track recovery strategy plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and thus, Adjuvant Chemotherapy
Interventions
CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.
HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) for the first 10 patients and thus, using CDDP plus Doxorubicin (15mg/L) thereafter, both for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min.
Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.
Eligibility Criteria
You may qualify if:
- Patients with no previous treatment and candidates for elective surgery with histological diagnosis of epithelial ovarian carcinoma;
- Clinical stage IIIB to IV, without suspicion of extra-abdominal metastasis;
- No other malignancies in activity;
- No previous treatments such as radiation, chemotherapy (except neoadjuvant chemotherapy in the study protocol) or major abdominal surgery;
- Absence of neuro-psychiatric disorders, history of drug allergies, and pregnancy or breast feeding;
- Aged between 18 and 70 years;
- Performance status 0-2 (ECOG, Eastern Cooperative Oncology Group) and / or greater than 70 points by the Karnofsky scale;
- Appropriated cardio-respiratory, hepato-renal and hematological reserves;
- Signing of the Consent Form.
You may not qualify if:
- Evidence of extensive retroperitoneal lymph node involvement or unresectable disease (i.e., massive involvement of the small bowel, mesentery, or hepatic pedicle, and ureteral or biliary obstruction) at the time of CRS/HIPEC;
- Residual disease after the CRS greater than or equal to 2.5 mm (CC-2 and CC-3);
- Limiting obesity for CRS or HIPEC;
- Disease progression, apparent or confirmed uncontrolled infection, or health impairment during NACT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Professor Fernando Figueira Integral Medicine Institutelead
- Hospital de Câncer de Pernambuco (Recife/PE)collaborator
- AC Camargo Cancer Center (São Paulo/SP)collaborator
- Instituto Brasileiro de Controle do Câncer (São Paulo/SP)collaborator
- Hospital de Cancer de Barretos - Fundacao Pio XII (Barretos/SP)collaborator
- Hospital Sao Jose (Criciuma/SC)collaborator
- Hospital de Base do Distrito Federal (Brasilia/DF)collaborator
Related Publications (3)
Batista TP, Carneiro VCG, Tancredi R, Teles ALB, Badiglian-Filho L, Leao CS. Neoadjuvant chemotherapy followed by fast-track cytoreductive surgery plus short-course hyperthermic intraperitoneal chemotherapy (HIPEC) in advanced ovarian cancer: preliminary results of a promising all-in-one approach. Cancer Manag Res. 2017 Dec 13;9:869-878. doi: 10.2147/CMAR.S153327. eCollection 2017.
PMID: 29263704RESULTBatista TP, Badiglian Filho L, Leao CS. Exploring flow rate selection in HIPEC procedures. Rev Col Bras Cir. 2016 Dec;43(6):476-479. doi: 10.1590/0100-69912016006014. English, Portuguese.
PMID: 28273222RESULTLustosa RJC, Batista TP, Carneiro VCG, Badiglian-Filho L, Costa RLR, Lopes A, Sarmento BJQ, Lima JTO, Mello MJG, LeAo CS. Quality of life in a phase 2 trial of short-course hyperthermic intraperitoneal chemotherapy (HIPEC) at interval debulking surgery for high tumor burden ovarian cancer. Rev Col Bras Cir. 2020;47:e20202534. doi: 10.1590/0100-6991e-20202534. Epub 2020 Jul 10. English, Portuguese.
PMID: 32667582RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thales P Batista, MD, MS
Professor Fernando Figueira Integral Medicine Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Physician and Researcher
Study Record Dates
First Submitted
September 22, 2014
First Posted
September 25, 2014
Study Start
February 1, 2015
Primary Completion
February 23, 2021
Study Completion
February 23, 2021
Last Updated
March 18, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share
We have no plan to make individual participant data (IPD) available to other researchers.