Your session is about to expire
← Back to Search
Chemotherapy
Chemotherapy + Atezolizumab for Colon Cancer
Phase 3
Waitlist Available
Led By Frank A Sinicrope
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
Age >= 12 years
Histologically proven stage III colon adenocarcinoma (any T [Tx, T1, T2, T3, or T4], N1-2M0; includes N1C); tumors must be deemed to originate in the colon including tumors that extend into/involve the small bowel (e.g. those at the ileocecal valve)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time from randomization to death, from any cause, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of chemotherapy drugs with atezolizumab to see if it is more effective than chemotherapy alone in treating patients with stage III colon cancer. Atezolizumab is an immunotherapy drug that may help the body's immune system attack the cancer.
Who is the study for?
This trial is for patients with stage III colon cancer and deficient DNA mismatch repair. Eligible participants must not have autoimmune diseases, active hepatitis B or C, severe allergies to certain antibodies or components in atezolizumab, nor require daily steroids or immunosuppressants. They should have proper liver and kidney function, no history of severe allergic reactions to specific proteins, and no prior treatments except possibly one cycle of mFOLFOX6.Check my eligibility
What is being tested?
The study compares the effectiveness of combination chemotherapy alone versus with atezolizumab in treating stage III colon cancer. Chemotherapy includes drugs like oxaliplatin, leucovorin calcium, and fluorouracil that kill or stop tumor cells from growing. Atezolizumab is an immunotherapy that may boost the immune system's attack on cancer.See study design
What are the potential side effects?
Potential side effects include allergic reactions to treatment components (like CHO cell products), organ inflammation due to immunotherapy agents such as atezolizumab, fatigue from chemotherapy drugs, digestive issues caused by both chemo and immunotherapy treatments, blood disorders related to bone marrow suppression by chemotherapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Select...
My cancer is a type of colon cancer that has not spread to distant parts of my body.
Select...
I am 16-17 years old and mostly can take care of myself.
Select...
My tumor was completely removed with clear margins, except possibly the sides.
Select...
I have only had one cycle of mFOLFOX6 for my current colon cancer.
Select...
I do not have any active autoimmune diseases like colitis or rheumatoid arthritis.
Select...
I am on a stable HIV treatment regimen.
Select...
I do not have active hepatitis B or C.
Select...
My CD4 count is above 250 and my HIV is undetectable.
Select...
I haven't taken high-dose steroids or immunosuppressants in the last week.
Select...
I am not planning to receive any other cancer treatments or participate in other clinical trials while in this study.
Select...
I am not allergic to 5-fluorouracil, oxaliplatin, or leucovorin.
Select...
I am 18 or older and can do most daily activities by myself.
Select...
My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.
Select...
I do not have severe nerve damage in my hands or feet.
Select...
I am under 16 and can do most activities without help.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time from randomization to death, from any cause, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time from randomization to death, from any cause, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival (DFS)
Secondary outcome measures
Incidence of adverse events
Overall survival
Side effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (combination chemotherapy, atezolizumab)Experimental Treatment8 Interventions
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive atezolizumab IV over 30-60 minutes on day 1 of each cycle, beginning in cycle 1 or 2. Treatment repeats every 14 days for up to 25 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
Group II: Arm II (combination chemotherapy)Active Control7 Interventions
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV as a bolus on day 1, then continuously over 46 hours on days 1-3 of each cycle. Treatment repeats every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo CT or MRI every 6 months for the first 2 years, then for years 3-5 or until evidence of relapse, whichever comes first. Patients may also undergo blood sample collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2720
Fluorouracil
2014
Completed Phase 3
~11540
Leucovorin Calcium
2011
Completed Phase 3
~12290
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190
Oxaliplatin
2011
Completed Phase 4
~2560
Atezolizumab
2017
Completed Phase 3
~5860
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,932,453 Total Patients Enrolled
Frank A SinicropePrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
107 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My platelet count is above the required level for my treatment stage.I am 12 years old or older.You need to have a certain number of a type of white blood cell called neutrophils in your blood.My kidney function, based on creatinine levels, is normal for my age and gender.Your oxygen levels without extra oxygen are below 85%.Your oxygen levels are below 88% even with extra oxygen.You have not had serious allergic reactions to certain types of medications made from human or animal proteins.Your creatinine level is not higher than 1.5 times the upper limit of normal.Your bilirubin levels should be within a certain range, unless you have Gilbert disease.I do not have active lung disease causing low oxygen levels.My cancer is a type of colon cancer that has not spread to distant parts of my body.I am 16-17 years old and mostly can take care of myself.Your AST and ALT levels are not more than 2.5 times the upper limit of normal.My cancer does not show a loss of MMR protein and is not MSI-H, or it is MSI-H but also shows loss of MMR protein.My tumor was completely removed with clear margins, except possibly the sides.My confirmed colon cancer has not spread to the rectum and any other cancers have been surgically removed.I have only had one cycle of mFOLFOX6 for my current colon cancer.I do not have active hepatitis B or C.My CD4 count is above 250 and my HIV is undetectable.I haven't taken high-dose steroids or immunosuppressants in the last week.I am not planning to receive any other cancer treatments or participate in other clinical trials while in this study.My tumor is located in a specific part of my colon or rectum.I am not pregnant and can prove it with a test taken within the last 7 days.My doctor confirmed I don't have cancer spread based on recent scans.I do not have any active autoimmune diseases like colitis or rheumatoid arthritis.I am on a stable HIV treatment regimen.I do not need daily medication to prevent infections.You are not allergic to Chinese hamster ovary (CHO) cell products or any part of the atezolizumab medicine.My thyroid function is normal, or I am taking supplements to keep it normal.I am not allergic to 5-fluorouracil, oxaliplatin, or leucovorin.My cancer has a specific genetic feature known as dMMR.I am 18 or older and can do most daily activities by myself.I have Lynch syndrome with a confirmed MMR gene mutation and dMMR.My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.I do not have severe nerve damage in my hands or feet.I am under 16 and can do most activities without help.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (combination chemotherapy, atezolizumab)
- Group 2: Arm II (combination chemotherapy)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Colon Cancer Patient Testimony for trial: Trial Name: NCT02912559 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on Atezolizumab's previous research?
"At present, 923 clinical trials are underway to study the efficacy of Atezolizumab. Of those active studies, 266 are in Phase 3. Although a large number of these trials for Atezolizumab originate in Guangzhou, Guangdong, there are actually 42746 locations conducting research on this treatment worldwide."
Answered by AI
Atezolizumab is most commonly used to target which type of cells?
"Atezolizumab, which is most often used as a treatment for macrocytic anemia, can also be taken to manage metastatic ureter urothelial carcinoma, bladder cancer, and other conditions."
Answered by AI
Do people who take Atezolizumab experience many side effects?
"Atezolizumab has received a Phase 3 safety rating from our analysts at Power. What this means is that while there are still some unknowns surrounding the efficacy of the medication, it has undergone multiple rounds of testing with positive results for safety."
Answered by AI
Are investigators still looking for more participants in this study?
"The clinical trial is still recruiting patients, as of today. This information can be found by looking at the posting date (9/12/2017) and last edit date (11/16/2022) on clinicaltrials.gov"
Answered by AI
Who else is applying?
What state do they live in?
Alabama
Texas
How old are they?
65+
What site did they apply to?
AdventHealth Orlando
Cookeville Regional Medical Center
MD Anderson League City
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
Hope something will work more than I’m recieving. As of now my treatment was successful, but want to see what options I have to ensure it does not return.
PatientReceived no prior treatments
I have been on chemo for over 5 years and it is getting more difficult to bounce-back from treatment, now that it is every other week.
PatientReceived no prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger