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Alkylating agents
Heated Chemotherapy + Surgery for Stomach Cancer
Phase 2
Waitlist Available
Led By Jeremy L Davis, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at staging laparoscopy
Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the absence of disseminated peritoneal disease must be obtained
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is testing if surgical removal of tumors plus heated intraperitoneal chemotherapy can improve survival in people with gastric cancers.
Who is the study for?
Adults over 18 with gastric cancer who've had chemotherapy for 3-6 months can join this trial. They should be able to have surgery, not have widespread cancer outside the abdomen, and their organs must work well. Pregnant women, those with serious illnesses or HIV without special approval can't participate.Check my eligibility
What is being tested?
The study is testing if removing stomach tumors through surgery plus heated chemo in the belly (HIPEC) improves survival. Patients will get two chemo drugs in their abdomen heated slightly above body temperature and another drug by vein.See study design
What are the potential side effects?
Possible side effects include pain requiring medication, infection risks needing antibiotics, potential need for blood transfusions due to bleeding or anemia, organ inflammation from chemo drugs, and general anesthesia risks during surgery.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tests show cancer spread in the abdomen lining.
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My tests show cancer cells in the fluid in my abdomen, but no widespread disease there.
Select...
I am older than 18 years.
Select...
My treatment includes drugs based on fluoropyrimidine or platinum.
Select...
My blood tests show normal organ function and I don't have anemia or infections.
Select...
I can do most of my daily activities without help.
Select...
My cancer is confirmed as gastric or gastroesophageal junction adenocarcinoma.
Select...
I am physically fit for HIPEC and stomach surgery.
Select...
I had my last chemotherapy less than 8 weeks ago and have mostly recovered from side effects.
Select...
I haven't had cancer, except for certain skin cancers or cervical pre-cancer, in the last 2 years.
Select...
I have records of my chemotherapy treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival
Secondary outcome measures
extra-peritoneal disease free survival
intraperitoneal progression free survival
morbidity
Side effects data
From 2023 Phase 3 trial • 521 Patients • NCT0410906665%
Alopecia
48%
Nausea
36%
Anaemia
26%
Fatigue
25%
Aspartate aminotransferase increased
24%
Diarrhoea
21%
Alanine aminotransferase increased
20%
Vomiting
20%
Asthenia
19%
Headache
19%
Neuropathy peripheral
19%
Neutropenia
17%
Constipation
16%
COVID-19
16%
Neutrophil count decreased
15%
Arthralgia
14%
Rash
13%
Decreased appetite
13%
Hypothyroidism
12%
Hyperglycaemia
12%
White blood cell count decreased
12%
Radiation skin injury
11%
Lymphopenia
11%
Myalgia
9%
Pruritus
9%
Infusion related reaction
9%
Cough
9%
Pyrexia
9%
Urinary tract infection
9%
Epistaxis
9%
Hypertension
8%
Blood alkaline phosphatase increased
7%
Dizziness
7%
Dyspepsia
7%
Dysgeusia
7%
Hot flush
6%
Paraesthesia
6%
Peripheral sensory neuropathy
6%
Abdominal pain upper
6%
Back pain
6%
Pain in extremity
6%
Illness
6%
Mucosal inflammation
6%
Leukopenia
6%
Hypersensitivity
6%
Hyperthyroidism
6%
Insomnia
5%
Anxiety
5%
Weight decreased
5%
Blood lactate dehydrogenase increased
5%
Folliculitis
4%
Abdominal pain
4%
Blood thyroid stimulating hormone increased
4%
Dry mouth
4%
Adrenal insufficiency
4%
Oedema peripheral
4%
Pain
3%
Dyspnoea
3%
Blood thyroid stimulating hormone decreased
3%
Hyponatraemia
3%
Stomatitis
3%
Dry eye
3%
Lacrimation increased
3%
Gastrooesophageal reflux disease
3%
Nasopharyngitis
3%
Lymphocyte count decreased
3%
Hypokalaemia
2%
Nail disorder
2%
Pulmonary embolism
2%
Postoperative wound infection
2%
Bone pain
2%
Breast pain
2%
Thrombocytopenia
2%
Depression
2%
Malignant neoplasm progression
2%
Rash maculo-papular
2%
Palpitations
2%
Dry skin
2%
Onycholysis
2%
Febrile neutropenia
2%
COVID-19 pneumonia
2%
Tachycardia
2%
Procedural pain
2%
Oropharyngeal pain
1%
Left ventricular failure
1%
Thyroiditis subacute
1%
Interstitial lung disease
1%
Embolism
1%
Cardiac perfusion defect
1%
Pneumonia bacterial
1%
Upper respiratory tract infection
1%
Cardiac failure
1%
Vertigo
1%
Myocarditis
1%
Cervix carcinoma
1%
Pemphigoid
1%
Immune-mediated adrenal insufficiency
1%
Hypotension
1%
Chills
1%
Pneumonia
1%
Myelosuppression
1%
Intracranial pressure increased
1%
Cardio-respiratory arrest
1%
Myocardial infarction
1%
Colitis
1%
Anaphylactic reaction
1%
Diabetic ketoacidosis
1%
Hepatitis cholestatic
1%
Infection
1%
Glomerulonephritis
1%
Arterial thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Nivo + Chemo (PTX QW + AC Q3W) / Nivo + ET
Arm A: Nivo + Chemo (PTX QW + AC Q2W) / Nivo + ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q3W) / ET
Arm B: Nivo Placebo + Chemo (PTX QW + AC Q2W) / ET
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1/Arm 1Experimental Treatment4 Interventions
HIPEC with gastrectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sodium Thiosulfate
2014
Completed Phase 3
~90
Surgery
2000
Completed Phase 3
~2550
Cisplatin
2013
Completed Phase 3
~1940
Mitomycin C
2019
Completed Phase 4
~820
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,658 Previous Clinical Trials
40,924,462 Total Patients Enrolled
Jeremy L Davis, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
3,292 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread beyond the peritoneum with significant fluid buildup.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am not pregnant or breastfeeding.I have undergone chemotherapy for 3 to 6 months before joining this study.My tests show cancer spread in the abdomen lining.My tests show cancer cells in the fluid in my abdomen, but no widespread disease there.I am older than 18 years.I have had surgery to look inside my abdomen and possibly tissue sampling.My treatment includes drugs based on fluoropyrimidine or platinum.I can receive Trastuzumab for my HER2-positive cancer if needed.My cancer in the abdomen is fully removable by surgery.My blood tests show normal organ function and I don't have anemia or infections.I can do most of my daily activities without help.My cancer is confirmed as gastric or gastroesophageal junction adenocarcinoma.I am physically fit for HIPEC and stomach surgery.I had my last chemotherapy less than 8 weeks ago and have mostly recovered from side effects.I haven't had cancer, except for certain skin cancers or cervical pre-cancer, in the last 2 years.I have records of my chemotherapy treatments.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is surgery a safe medical procedure for patients?
"Surgery is given a score of 2 out of 3 in terms of safety. This reflects the fact that, while there are Phase 2 trials underway testing its efficacy, none have been completed yet."
Answered by AI
Are there any prior case studies of surgery being used therapeutically?
"At the current moment, there are 755 on-going studies related to surgery. Out of those, 294 have reached Phase 3 testing. Even though most of these trials take place in Shanghai, China, there are 44405 total locations worldwide where these tests are being conducted."
Answered by AI
What types of ailments or injuries often require surgery?
"Depending on the severity and location, carcinomas in the head and neck area, as well as cervical and low-grade upper tract urothelial cancers can be managed through surgery."
Answered by AI
How many people can join this study at most?
"According to the clinicaltrials.gov website, this trial is still open and recruiting patients. The study was first posted on June 5th, 2017, and has since enrolled 40 participants across 1 site."
Answered by AI
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