Gastric AdenocarcinomaPhase 2NCT02891447

Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer

A Phase 2 study testing Cisplatin, Hyperthermic Intraperitoneal Chemotherapy and Mitomycin in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
What is being tested?: Cisplatin, Hyperthermic Intraperitoneal Chemotherapy and Mitomycin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2016to 11 Apr 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 60,000/Ul
Serum creatinine =< 1.5 mg/dL

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Distant metastatic disease of peritoneum may be visualized on imaging:
Positive peritoneal cytology
Carcinomatosis on diagnostic laparoscopy or laparotomy
Completion of preoperative systemic chemotherapy and preoperative laparoscopic HIPEC

Who cannot join

Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung)
Infections such as pneumonia or wound infections that would preclude protocol therapy
Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
Subjects deemed unable to comply with study and/or follow-up procedures
Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity

Trial locations and contacts

1 site in 1 country.

United States1 site

M D Anderson Cancer Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology

Read the detailed description

PRIMARY OBJECTIVES:

To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.

SECONDARY OBJECTIVES:

To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.

OUTLINE:

Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

After completion of study treatment, patients are followed up within 4 weeks, and then every 6 months for 5 years.

Conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
Being tested: Cisplatin, Hyperthermic Intraperitoneal Chemotherapy, Mitomycin
Medical subject headings: Peritoneal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CisplatinDrug
Also called Abiplatin, Blastolem, Briplatin, CDDP
Given intraperitoneally
Hyperthermic Intraperitoneal ChemotherapyDrug
Also called HIPEC
Undergo HIPEC
MitomycinDrug
Also called Ametycine, MITO, MITO-C, Mito-Medac
Given intraperitoneally

Study groups in NCT02891447
Study group	Role	What they receive
Treatment (mitomycin, cisplatin)	Experimental	Patients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy. Receives: Drug: Cisplatin; Drug: Hyperthermic Intraperitoneal Chemotherapy; Drug: Mitomycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival
Overall survival from the date of diagnosis in subjects with stage IV gastric cancer
Measured: Date of diagnosis to date of death or last follow-up

Secondary outcomes (1)

Clavien-Dindo Surgical Complications
90-day surgical complications graded according to an accepted classification scale (Clavien-Dindo) Classification of Surgical Complications Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.
Grade III: Requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complication (including CNS complications)‡ requiring IC/ICU-management Grade V: Death of a patient
Measured: 90-days from surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201611 Apr 2023

First posted7 Sep 2016 (estimated)
Study start1 Sep 2016
Primary completion11 Apr 2023
Study completion11 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02891447
Sponsor's protocol ID: 2016-0269
Other IDs: NCI-2018-02341, 2016-0269
Status last verified: Aug 2024
First submitted: 1 Sep 2016
Last updated: 19 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Badgwell B, Ikoma N, Murphy MB, Wang X, Estrella J, Roy-Chowdhuri S, Das P, Minsky BD, Lano E, Song S, Mansfield P, Ajani J. A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology. Ann Surg Oncol. 2021 Jan;28(1):258-264. doi: 10.1245/s10434-020-08739-5. Epub 2020 Jun 17.
PubMed 32556731

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastric Adenocarcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Chemoperfusion (HIPEC) in Patients With Gastric Adenocarcinoma and Carcinomatosis or Positive Cytology
ClinicalTrials.gov ID: NCT02891447
Acronym / sponsor ID: 2016-0269
Conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Peritoneal Carcinomatosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 1 Sep 2016 (actual)
Primary completion: 11 Apr 2023 (actual)
Study completion: 11 Apr 2023 (actual)
First posted: 7 Sep 2016 (estimated)
Results: Posted 19 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess overall survival from the date of diagnosis in subjects with stage IV gastric or gastroesophageal cancer and positive cytology or carcinomatosis after cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration.

SECONDARY OBJECTIVES:

To assess the safety of cytoreduction, gastrectomy, and hyperthermic intraperitoneal chemotherapy administration for subjects with gastric or gastroesophageal cancer and positive cytology or carcinomatosis.

OUTLINE:

Patients undergo hyperthermic intraperitoneal chemotherapy (HIPEC) comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

After completion of study treatment, patients are followed up within 4 weeks, and then every 6 months for 5 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (mitomycin, cisplatin)	Experimental	Drug: Cisplatin, Drug: Hyperthermic Intraperitoneal Chemotherapy, Drug: MitomycinPatients undergo HIPEC comprised of mitomycin and cisplatin given intraperitoneally over 60 minutes during standard of care cytoreduction and gastrectomy.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Cytologic or histologic proof of adenocarcinoma of the stomach or gastroesophageal junction
Leukocytes >= 3,000/uL
Absolute neutrophil count >= 1,500/uL
Platelets >= 60,000/Ul

Key exclusion criteria (6 listed)

Distant metastatic disease not limited to peritoneum: Solid organ metastases (liver, central nervous system, lung)
Infections such as pneumonia or wound infections that would preclude protocol therapy
Women with a positive urine or serum pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence
Subjects with unstable angina or New York Heart Association grade II or greater congestive heart failure
Subjects deemed unable to comply with study and/or follow-up procedures

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CisplatinAlso: Abiplatin, Blastolem, Briplatin, CDDPGiven intraperitoneally	Drug	Treatment (mitomycin, cisplatin)
Hyperthermic Intraperitoneal ChemotherapyAlso: HIPECUndergo HIPEC	Drug	Treatment (mitomycin, cisplatin)
MitomycinAlso: Ametycine, MITO, MITO-C, Mito-MedacGiven intraperitoneally	Drug	Treatment (mitomycin, cisplatin)

Primary outcome

Overall Survival
Time frame: Date of diagnosis to date of death or last follow-up
Overall survival from the date of diagnosis in subjects with stage IV gastric cancer

1 secondary outcome

Clavien-Dindo Surgical Complications
Time frame: 90-days from surgery

Results and safety

Results posted to the registry on 19 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy	20	20

Primary outcome: Overall Survival

Time frame: Date of diagnosis to date of death or last follow-up. Median (95% Confidence Interval). Unit: Months

Measure	Single Arm of Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy n = 20
Value	22.1 (15.4 to 30.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Deaths were assessed up to 5 years. Complications according to the grading scale above were assessed 90 days from the date of surgery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cytoreduction, Gastrectomy, and Intraperitoneal Chemotherapy	7 of 20 (35%)	15 of 20 (75%)	14 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32556731Badgwell B, Ikoma N, Murphy MB, Wang X, Estrella J, Roy-Chowdhuri S, Das P, Minsky BD, Lano E, Song S, Mansfield P, Ajani J. A Phase II Trial of Cytoreduction, Gastrectomy, and Hyperthermic Intraperitoneal Perfusion with Chemotherapy for Patients with Gastric Cancer and Carcinomatosis or Positive Cytology. Ann Surg Oncol. 2021 Jan;28(1):258-264. doi: 10.1245/s10434-020-08739-5. Epub 2020 Jun 17.
MD Anderson Cancer Center WebsiteLink provided by the sponsor.

Related trials for Gastric Adenocarcinoma

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
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Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
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RecruitingPhase 2
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian D Badgwell principal investigator

M.D. Anderson Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: Date of diagnosis to date of death or last follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02891447, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 7 Nov 2026.