CLINICAL TRIAL

Hyperthermic intraperitoneal chemotherapy for Ovary Cancer

Newly Diagnosed
Stage III
Recruiting · 18+ · Female · Baltimore, MD

This study is evaluating whether a surgery and chemotherapy combination may help treat advanced stage ovarian cancer.

See full description

About the trial for Ovary Cancer

Eligible Conditions
Ovarian Cancer (Epithelial) · Ovarian Carcinoma · Fallopian Tube Neoplasms · Stage III Ovarian Cancer · Advanced Ovarian Cancer · Ovarian Neoplasms · Carcinoma, Ovarian Epithelial · Fallopian Tubes Cancer · Primary Peritoneal Carcinoma · Fallopian Tube Carcinoma · Carcinoma

Treatment Groups

This trial involves 2 different treatments. Hyperthermic Intraperitoneal Chemotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cytoreductive Surgery (CRS)
PROCEDURE
Adjuvant Chemotherapy
DRUG
Questionnaire
OTHER
Carboplatin
DRUG
Paclitaxel
DRUG
Hyperthermic intraperitoneal chemotherapy
PROCEDURE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Cisplatin
DRUG
Cytoreductive Surgery (CRS)
PROCEDURE
Adjuvant Chemotherapy
DRUG
Questionnaire
OTHER
Paclitaxel
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytoreductive Surgery (CRS)
2015
Completed Phase 2
~20
Adjuvant Chemotherapy
2015
Completed Phase 2
~20
Carboplatin
FDA approved
Paclitaxel
FDA approved

Eligibility

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Ovary Cancer or one of the other 10 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
No prior treatment or significant surgery for the management of ovarian, fallopian tube, or primary peritoneal carcinoma; History of laparoscopic procedures to obtain diagnostic biopsies will be permitted in the study
Histological confirmation
≤1 cm residual disease at the completion of the cytoreductive surgery (GOG criteria for optimally cytoreduction)
Platelets ≥100,000/mm3
Hemoglobin ≥ 8.5 g/dL
1) Creatinine ≤1.5 times the upper limit of normal or a calculated creatinine clearance ≥60ml/min
Clinical presentation of ovarian, fallopian tube or primary peritoneal cancer
Stage III/IV disease
Eastern Cooperative Oncology Group performance status 0-2 or Karnofsky performance status ≥ 70%
Absolute neutrophil count (ANC) ≥1,000/mm3
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
Screening: ~3 weeks
Treatment: Varies
Reporting: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Baseline, 4 weeks post-operative, upon completion of systemic chemotherapy, and years 1, 2, 3, 4, & 5.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Hyperthermic intraperitoneal chemotherapy will improve 1 primary outcome, 3 secondary outcomes, and 1 other outcome in patients with Ovary Cancer. Measurement will happen over the course of 30 days post-operative.

Post-operative complication rates
30 DAYS POST-OPERATIVE
Compare post-operative complication rates between study arms
30 DAYS POST-OPERATIVE
Risk factors for morbidity and mortality
DURING & AT STUDY COMPLETION
Determine percent of patients wtih Grade I-V adverse events according to NCI criteria, Common Terminology Criteria for AE (CTCAE).
DURING & AT STUDY COMPLETION
Evaluate the rate of progression free survival
AT 24 MONTHS
Time from intervention to disease recurrence
AT 24 MONTHS
Evaluate overall survival
AT 1, 3, AND 5 YEARS
Time from intervention to death
AT 1, 3, AND 5 YEARS
Assessment of quality of life
BASELINE, 4 WEEKS POST-OPERATIVE, UPON COMPLETION OF SYSTEMIC CHEMOTHERAPY, AND YEARS 1, 2, 3, 4, & 5
FACT-O questionnaire to assess quality of life in both study arms
BASELINE, 4 WEEKS POST-OPERATIVE, UPON COMPLETION OF SYSTEMIC CHEMOTHERAPY, AND YEARS 1, 2, 3, 4, & 5

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is ovary cancer?

Ovary cancer starts in the ovaries, the woman's fertility hormones produced by the ovaries play an important role in the disease and the female reproductive organs are commonly affected. However, there is no evidence to suggest that female reproductive organs are the most often involved in cancer. In fact, ovarian cancer (which accounts for up to 10% of all cases of breast cancer in women younger than 40 in developed countries) is the cause of around 200 000 deaths in the UK in women aged 25 and under each year.

Anonymous Patient Answer

What causes ovary cancer?

Ovary cancer is primarily genetic. It is only in the second decade of life that a cancer develops in a woman who has not previously had a cancer. If she does have a cancer in the first three decades, ovarian cancer is rare. Most ovarian cancer occurs in post-menopausal women. It is the fifth-most devastating cancer among women.

Anonymous Patient Answer

Can ovary cancer be cured?

If [standard chemotherapy and surgery are feasible], treatment to cure the disease may be possible. We believe that this treatment may be a good option as the disease can be cured with no long-term side effects to the patient.

Anonymous Patient Answer

What are the signs of ovary cancer?

The signs of ovarian cancer include frequent, painful or bloody urination, pelvic mass or a lump or other symptom that does not go away with menstruation. These symptoms may also be linked to ovarian cancer. The signs of ovarian cancer may mimic the signs of other gynecological conditions. As a result, more screening should be done for ovarian cancer.

Anonymous Patient Answer

How many people get ovary cancer a year in the United States?

About 30.2 million American women are predicted to develop ovarian cancer during their lifetime. Approximately 8,700 women will be diagnosed with primary ovarian cancer in 2012.

Anonymous Patient Answer

What are common treatments for ovary cancer?

Most women undergo surgery, and chemotherapy and radiation therapy are used if there is no complete resection of the ovarian tumor. A subset of women are eligible to receive a palliative course of hormonal therapy.

Anonymous Patient Answer

What are the latest developments in hyperthermic intraperitoneal chemotherapy for therapeutic use?

The recent advances in IPC have improved the outlook for patients with ovarian cancer. More recently, the development of new cytotoxic agents has provided a new chance for improving the prognosis of patients with ovarian cancer. The exact mechanism of the hyperthermic IPC remains to be elucidated, but the application of this treatment to ovarian cancer could be useful in improving the prognosis of patients with ovarian cancer.

Anonymous Patient Answer

What are the common side effects of hyperthermic intraperitoneal chemotherapy?

The standard HIC regimen causes adverse effects on most patients with advanced ovarian cancer. These include the most common side effects of chemotherapeutic drugs. For patients whose debility to chemotherapy, a new regimen with a higher dose of paclitaxel should be tried.

Anonymous Patient Answer

Is hyperthermic intraperitoneal chemotherapy safe for people?

This research demonstrates that HIPEC is safe for people and provides some comfort to people with ovarian cancer. Better survival of women with stage III ovarian cancer was observed when compared to women treated by standard surgery.

Anonymous Patient Answer

What is the survival rate for ovary cancer?

Ovary cancer is the 3rd leading cause of death in the United States. It can be divided into low-stage (S1), intermediate-stage (S2), and high-stage (S3) types. The overall 3-year survival rate for advanced ovarian cancer is 37%. For younger women, the prognosis is worse: the five-year survival rate is 24%. Factors associated with unfavorable outcome are advanced-stage disease, high-grade histology, residual tumor after primary surgery, and presence of extrapelvic metastases. Five-year survival is higher in low-stage disease and does not appear to be affected by grade or tumor size.

Anonymous Patient Answer

What is the primary cause of ovary cancer?

Most [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer)s display two types of cells, cancer-like cells with a single nucleus and non-cancer-like cells with multiple nuclei. The cancers are benign in about 80 % of cases. In the rest, cancer-like cells are always found with atypical nuclei, suggesting that the nuclei of these cells have had chromosomal instability. The primary cause of ovarian cancer is unclear, but has important consequences for prognosis and treatment.

Anonymous Patient Answer

Have there been any new discoveries for treating ovary cancer?

In 2008, the first drugs to treat ovarian cancer were approved by the U.S. Food and Drug Administration. In December 2011, it was published that a drug called pegylated liposomal doxorubicin produced better outcomes in patients with advanced ovarian cancer. Also in 2011, it was reported that the platinum-containing anticancer drugs have been shown to elicit apoptosis in patients with ovarian cancer. This finding led to the invention of the platinum-taxane-based combination of drugs that are well known to induce apoptosis and are being tested as treatment of ovarian cancer as well. This combination is currently being tested in a clinical trial that has enrolled over 700 patients with ovarian cancer.

Anonymous Patient Answer
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