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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients who are known to have Lynch syndrome, have been found to carry a specific germline mutation in an MMR gene (MLH1, MSH2, MSH6, PMS2), and have been shown to be dMMR by IHC are eligible to participate
Alternatively, for patients < 18 years of age, maximum serum creatinine =< the below age-gender-specific norms:
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow Upfrom the time from randomization to death, from any cause, assessed up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
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.
Eligible Conditions
- Stage III Colon Cancer
- Colorectal Cancer
- DNA Repair Disorder
- Lynch Syndrome
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have never had a severe allergic reaction to certain types of medications called chimeric, human, or humanized antibodies.
Select...
You are not allergic to any ingredients in the atezolizumab medication, including Chinese hamster ovary (CHO) cell products.
Select...
You do not have moderate or severe nerve damage in your arms or legs.
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 • NCT0200822727%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Pyrexia
18%
Constipation
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel
Awards & Highlights
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.
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
Magnetic Resonance Imaging
2017
Completed Phase 3
~1250
Leucovorin Calcium
2011
Completed Phase 3
~12290
Oxaliplatin
2011
Completed Phase 4
~1990
Fluorouracil
2014
Completed Phase 3
~11540
Atezolizumab
2016
Completed Phase 3
~6040
Biospecimen Collection
2004
Completed Phase 1
~1540
Computed Tomography
2017
Completed Phase 2
~2890
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,264,177 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:- You do not have any ongoing autoimmune diseases such as colitis, inflammatory bowel disease, rheumatoid arthritis, or adrenal insufficiency.You do not have moderate or severe nerve damage in your arms or legs.You have never had a severe allergic reaction to certain types of medications called chimeric, human, or humanized antibodies.You are not allergic to any ingredients in the atezolizumab medication, including Chinese hamster ovary (CHO) cell products.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (combination chemotherapy)
- Group 2: Arm I (combination chemotherapy, atezolizumab)
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?
Cookeville Regional Medical Center
MD Anderson League City
MD Anderson in Sugar Land
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?
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
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