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Alkylating agents

Hyperthermic Intraperitoneal Chemotherapy for Ovarian Cancer

Q: Is the recruitment of participants still ongoing for this experiment?

<p>Affirmative. The clinical trial database reveals that this experiment is currently accepting participants, having been first released on June 13th 2022 and edited as recently as September 16th 2022. 45 candidates must be recruited from a single location.</p>

Q: What is the current enrollment for this research trial?

<p>Affirmative. According to the clinicaltrials.gov database, this trial is presently accepting participants. The study was initially posted on June 13th 2022 and has since been updated on September 16th of that same year. A total of 45 patients will be welcomed at 1 particular location for the duration of the trial.</p>

Phase < 1

Recruiting

Led By Floor Backes, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance-status score of 0-2

Following 3-4 cycles of NACT at least 50% decrease in CA-125 level between pre-cycle 1 and post-cycle 3/prior to surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up for 3-5 years after study

Awards & highlights

Study Summary

This trial is testing the side effects of hyperthermic intraepithelial chemotherapy with cisplatin before or after surgery in patients with ovarian, fallopian tube, or peritoneal cancer receiving chemotherapy before surgery.

Who is the study for?

This trial is for adults over 18 with stage III or IV ovarian, fallopian tube, or peritoneal cancer who've had some chemo but still need surgery. They should be fit for major surgery and have a good performance status score (0-2). People can't join if they have inflammatory bowel disease, recent other cancers except certain skin cancers and cervical carcinoma in situ, allergies to the drugs used here, or uncontrolled illnesses like heart failure.Check my eligibility

What is being tested?

The study tests two approaches: giving heated chemotherapy with cisplatin during surgery versus standard cisplatin before surgery. The goal is to see which method might kill more tumor cells effectively. Participants will also complete quality-of-life questionnaires to assess how these treatments impact their well-being.See study design

What are the potential side effects?

Side effects may include reactions to chemotherapy such as nausea, kidney damage from cisplatin, nerve damage from paclitaxel leading to numbness or tingling in hands and feet, blood count changes increasing infection risk, fatigue and potential complications from major surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and am up and about more than half of the day.

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My CA-125 levels dropped by at least 50% after 3-4 cycles of chemotherapy before surgery.

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I am considered fit for major surgery according to ASA standards.

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My cancer responded to the initial 3-4 cycles of chemotherapy.

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I have completed 3 cycles of a specific chemotherapy before surgery.

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I am older than 18 years.

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I have been newly diagnosed with advanced ovarian, fallopian tube, or peritoneal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ for 3-5 years after study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~for 3-5 years after study

This trial's timeline: 3 weeks for screening, Varies for treatment, and for 3-5 years after study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of chemotherapy-related adverse events

Secondary outcome measures

Feasibility of chemotherapy immediately perioperatively

Percentage of patients in Arm C with a treatment free interval of < 8 weeks

Quality of life (QOL) assessment EORTC QLQ-C30

+2 more

Side effects data

From 2012 Phase 3 trial • 256 Patients • NCT01005680

51%

Neutropenia

47%

Leukopenia

46%

Nausea

43%

Vomiting

35%

Anaemia

31%

Decreased appetite

26%

Haemoglobin decreased

26%

Fatigue

25%

Constipation

25%

White blood cell count decreased

24%

Neutrophil count decreased

19%

Alanine aminotransferase increased

13%

Platelet count decreased

12%

Rash

10%

Aspartate aminotransferase increased

10%

Thrombocytopenia

Blood sodium decreased

Hypokalaemia

Insomnia

Pyrexia

Hyponatraemia

Blood creatinine increased

Lymphopenia

Diarrhoea

Dyspepsia

Red blood cell count decreased

Cough

Dizziness

Bone marrow failure

Ischaemic stroke

Cerebral infarction

Dyspnoea

Pulmonary embolism

Embolism venous

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Gemcitabine Plus Cisplatin (GC)

Pemetrexed Plus Cisplatin (PC)

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (carboplatin, paclitaxel, CRS, cisplatin)Experimental Treatment6 Interventions

OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM III: Patients receive cisplatin IV the day prior to interval debulking surgery

Group II: Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin)Experimental Treatment7 Interventions

OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM II: Patients undergo HIPEC and receive cisplatin IV over 90 minutes at the time of interval debulking surgery

Group III: Arm I (carboplatin, paclitaxel, CRS)Active Control5 Interventions

OUTLINE: Patients receive carboplatin IV and paclitaxel IV on day 1. Treatment repeats every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity. Within 3-4 weeks following the third or fourth neoadjuvant cycle, patients who achieve complete or partial response undergo interval debulking surgery Patients are randomized to 1 of 3 arms. ARM I: No chemotherapy immediately before, during or after surgery. Carboplatin/paclitaxel is given 3-4 weeks prior to surgery and again 2-4 weeks after surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

FDA approved

Platinum

Not yet FDA approved

Cytoreductive Surgery

2011

Completed Phase 1

~150

Hyperthermic Intraperitoneal Chemotherapy

2010

Completed Phase 3

~210

Paclitaxel

FDA approved

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor

320 Previous Clinical Trials

290,122 Total Patients Enrolled

2 Trials studying Ovarian Cancer

705 Patients Enrolled for Ovarian Cancer

Floor Backes, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center

5 Previous Clinical Trials

295 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05415709 — Phase < 1

Ovarian Cancer Research Study Groups: Arm I (carboplatin, paclitaxel, CRS), Arm II (carboplatin, paclitaxel, CRS, HIPEC, cisplatin), Arm III (carboplatin, paclitaxel, CRS, cisplatin)

Ovarian Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT05415709 — Phase < 1

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05415709 — Phase < 1

Frequently Asked Questions

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

Is the recruitment of participants still ongoing for this experiment?

"Affirmative. The clinical trial database reveals that this experiment is currently accepting participants, having been first released on June 13th 2022 and edited as recently as September 16th 2022. 45 candidates must be recruited from a single location."

Answered by AI

What is the current enrollment for this research trial?

"Affirmative. According to the clinicaltrials.gov database, this trial is presently accepting participants. The study was initially posted on June 13th 2022 and has since been updated on September 16th of that same year. A total of 45 patients will be welcomed at 1 particular location for the duration of the trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer

Floor Backes, MD 2022. "Hyperthermic Intraperitoneal Chemotherapy With Cisplatin During Surgery or Cisplatin Before Surgery for the Treatment of Stage III or IV Ovarian, Fallopian Tube or Peritoneal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05415709.

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