Trial of Cytoreductive Surgery and HIPEC in Patients With Primary and Secondary Peritoneal Cancers

NCT03604653 | Completed

• 1 other identifier: holynameHIPEC1
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with primary peritoneal cancer or secondary peritoneal cancers from stomach, colorectal, appendiceal, and gynecological primary origin will be screened by pathology and staging to see if they are eligible to undergo cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC). To be eligible for the study, patients must be over 18 years of age, have appropriate pathology and stage with disease confined to the peritoneal cavity, have a good performance status, have laboratory values that fall within safe ranges to undergo an operation and receive intraperitoneal chemotherapy. The chemotherapeutic agent and dose will be assigned based on pathological diagnosis in accordance with current standard of care. Surgery will be performed with the goal of removing all visible tumor that may require removal of adjacent organs. Once only microscopic disease is present, the chemotherapy will be delivered directly into the peritoneum via intraperitoneal hyperthermia and perfusion device. This will continue for 90 minutes. Patients will be followed for tumor response, survival, toxicity, complications, quality of life, and tumor markers. They will have regular follow up visits with the surgeon, undergo routine surveillance imagings, and receive follow up phone calls periodically.

Conditions

Stomach Cancer; Colorectal Cancer; Appendiceal Cancer; Ovarian Cancer; Uterine Cancer; Cervical Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma

Keywords

HIPEC; Stomach cancer; colorectal cancer; appendiceal cancer; ovarian cancer; uterine cancer; cervical cancer; fallopian tube cancer; primary peritoneal carcinoma; intraperitoneal chemotherapy

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Time from HIPEC treatment to death

  up to 10 years

• Disease-free Survival

  Time from HIPEC treatment to either recurrence or relapse of cancer, or death

  up to 10 years

Secondary Outcomes (4)

• Complications

  90 Days

• Treatment related quality of life changes as measured by the WHO QOL-BREF questionnaire

  Up to 10 years

• Tumor Markers

  up to 10 years

• Toxicity as measured by treatment related adverse events according to the NCI CTCAE v 4.0

  90 Days

Study Arms (4)

Stomach

Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes, CDDP Cisplatin 50mg/m2@ time 0

Device: HIPEC; Drug: Mitomycin c; Drug: CDDP 50

Colorectal, Appendiceal, Pseudomyxoma Peritonei

Heated Intraperitoneal Chemotherapy with Mitomycin C 30mg at time 0, 10mg at time 45 minutes

Device: HIPEC; Drug: Mitomycin c

Primary Peritoneal

Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 50mg/m2 at time 0, Doxorubicin 15mg/m2 at time 0

Device: HIPEC; Drug: CDDP 50; Drug: Doxorubicin

Ovarian, Cervical, Uterine, Fallopian Tube

Heated Intraperitoneal Chemotherapy with CDDP Cisplatin 75mg/m2 at time 0

Device: HIPEC; Drug: CDDP 75

Interventions

HIPEC DEVICE

Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes

Also known as: Chemo bath

Colorectal, Appendiceal, Pseudomyxoma Peritonei; Ovarian, Cervical, Uterine, Fallopian Tube; Primary Peritoneal; Stomach

Mitomycin c DRUG

MMC 30mg@ T0, 10mg@T45 min

Also known as: MMC

Colorectal, Appendiceal, Pseudomyxoma Peritonei; Stomach

CDDP 50 DRUG

50mg/m2@T0

Also known as: Cisplatin

Primary Peritoneal; Stomach

CDDP 75 DRUG

75mg/m2@T0

Also known as: Cisplatin

Ovarian, Cervical, Uterine, Fallopian Tube

Doxorubicin DRUG

15mg/m2@T0

Also known as: DXR

Primary Peritoneal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary peritoneal cancers and secondary peritoneal cancers from stomach, colorectal, appendiceal, and/or gynecological origins who are eligible by stage and pathology for surgical debulking and HIPEC, and who meet criteria to undergo an extensive operation.

You may qualify if:

• Age \>18
• Diagnosis at the time of resection or on frozen section of:
• recurrent or primary stomach, colorectal or appendiceal cancer with regional spread that is confined to the peritoneal cavity
• primary peritoneal cancer
• ovarian cancer stage IC or higher
• uterine or cervical cancer stage IIA or higher with recurrence confined to the peritoneum
• fallopian tube cancer stage III or recurrence confined to the peritoneum ECOG performance status of 0,1, or 2
• Lab values:
• absolute neutrophil count \>1500
• platelets \>100,000
• creatinine less than or equal to 2.0mg/dL
• bilirubin less than or equal to 1.5 times the upper limit of normal
• SGOT and alkaline phosphatase less than or equal to 2.5 times the upper limit of normal
• patients of childbearing age must have a negative serum pregnancy test and be using an effective form of contraception

You may not qualify if:

• Extra-peritoneal disease or unresectable disease
• Any known sensitivity to the chemotherapeutic agents used in the study
• Significant medical comorbidities that would prevent the patient from being able to complete the protocol (at discretion of investigator)
• Patients with gynecological malignancy who desire future fertility
• An informed consent cannot be obtained from the patient or power of attorney

Sponsors & Collaborators

• Holy Name Medical Center, Inc.: lead

Study Sites (1)

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Colorectal Neoplasms; Appendiceal Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Uterine Cervical Neoplasms; Fallopian Tube Neoplasms

Interventions

Hyperthermic Intraperitoneal Chemotherapy; Mitomycin; Cisplatin; Doxorubicin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cecal Neoplasms; Cecal Diseases; Endocrine Gland 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; Uterine Diseases; Uterine Cervical Diseases; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced; Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 27, 2018
• Study Start: May 15, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)