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Alkylating agents
Chemotherapy + Immunotherapy for Rectal Cancer
Phase 2
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously untreated mesothelioma
Body weight >30 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to five years
Awards & highlights
Study Summary
This trial is testing whether adding low-dose chemotherapy and/or immunotherapy to standard radiation therapy can improve outcomes in patients with locally advanced rectal cancer.
Who is the study for?
The SMARTEST trial is for adults over 18 with previously untreated mesothelioma, stages I-III. Participants must be fit for surgery, have good organ function, weigh more than 30 kg, and have a life expectancy of at least 12 weeks. They should not have had recent cancer treatments or other clinical trials that could interfere.Check my eligibility
What is being tested?
This phase II trial tests low dose cyclophosphamide with radiation before surgery (Arm A) against radiation alone (Arm B). After surgery, eligible patients from both arms receive tremelimumab-durvalumab to assess safety and effectiveness.See study design
What are the potential side effects?
Potential side effects include immune-related reactions due to tremelimumab-durvalumab therapy such as inflammation in various organs, fatigue, digestive issues and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mesothelioma and have not received any treatment for it.
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I weigh more than 30 kilograms.
Select...
My cancer is at stage I, II, or III based on specific scans.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
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My condition is confirmed mesothelioma through tissue analysis.
Select...
My tumor can be safely biopsied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to five years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to five years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CD8 TILs density / gross tumor volume (GTV)
Secondary outcome measures
Survival
Other outcome measures
Proportional change in circulating CD8 RA+ effector memory T cells, Proportional change in circulating CD4 RA+ effector memory T cells
Side effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
Trial Design
2Treatment groups
Experimental Treatment
Group I: Radiation+Drug (Arm A)Experimental Treatment3 Interventions
sub-ablative radiation plus low dose cyclophosphamide followed by surgery and adjuvant immunotherapy
Group II: Radiation alone (Arm B)Experimental Treatment2 Interventions
sub-ablative radiation alone followed by surgery and adjuvant immunotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Tremelimumab
Not yet FDA approved
Durvalumab
FDA approved
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,475 Previous Clinical Trials
485,060 Total Patients Enrolled
5 Trials studying Mesothelioma
1,579 Patients Enrolled for Mesothelioma
OICRUNKNOWN
3 Previous Clinical Trials
265 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy to the chest area before.I have not had major surgery within the last 28 days.You have participated in a study involving durvalumab or tremelimumab before, no matter which treatment you received.I have or had an autoimmune or inflammatory disorder.My doctor thinks I can undergo surgery and combined treatment.My cancer has spread to distant parts of my body, including possibly the brain or spine.I have tested positive for HIV or have active tuberculosis.I don't have lasting side effects from cancer treatment, except for hair loss or skin changes.I have mesothelioma and have not received any treatment for it.I do not have an active hepatitis infection.I have not received a live vaccine in the last 30 days.I weigh more than 30 kilograms.I haven't taken immunosuppressive drugs in the last 14 days.I am not currently on any cancer treatments like chemotherapy or hormone therapy.I am not pregnant or breastfeeding and agree to use birth control during and after treatment.I have received an organ transplant from another person.My cancer is at stage I, II, or III based on specific scans.I am willing and able to follow the study's treatment plan and attend all visits.I have nerve damage that affects my daily activities.I have a severe side effect that won't worsen with durvalumab or tremelimumab, as confirmed by a study doctor.I have had cancer before.I have had cancer spread to the lining of my brain and spinal cord.You have a history of a current weakened immune system.I am 18 years old or older.I have a serious illness like heart or lung disease that prevents me from getting radiation therapy.I do not have any unmanaged ongoing illnesses.I have had a brain scan with contrast before joining the study.Your heart's electrical activity (QT interval) is longer than normal when measured on multiple ECG tests.I am fully active or can carry out light work.My condition is confirmed mesothelioma through tissue analysis.My organs and bone marrow are functioning well.You are expected to live for at least 12 weeks.My tumor can be safely biopsied.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation alone (Arm B)
- Group 2: Radiation+Drug (Arm A)
Awards:
This trial has 2 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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 the age qualification for this research higher than 25 years?
"The acceptable age range for participants is 18 to 95, as stipulated in the clinical trial's inclusion rules."
Answered by AI
Is Cyclophosphamide a feasible treatment option with minimal hazards?
"Cyclophosphamide was deemed to have a safety rating of 2, as it is currently undergoing Phase 2 testing. This indicates there are some data points supporting the drug's safety but no evidence yet for its efficacy."
Answered by AI
Is my eligibility to join this medical experiment sufficient?
"This research trial is recruiting 30 individuals with malignant mesothelioma ranging in age from 18 to 95. The primary eligibility criteria include: serum bilirubin ≤1.5 x institutional upper limit of normal (ULN), capacity for informed consent and compliance, an Eastern Cooperative Oncology Group performance score of 0 or 1, body weight greater than 30 kg, haemoglobin ≥9.0 g/dL , ANC ≥1.0 × 109 /L, platelet count ≥75 × 109/L, AST (SGOT)/ALT (SGPT) ≤2.5x ULN unless liver metastases"
Answered by AI
What is the cap for the amount of participants joining this clinical investigation?
"Yes, the clinical trial is still open for enrollment. According to records on clinicaltrials.gov, this research endeavor was initially posted online on May 9th 2022 and has been recently updated as of May 13th 2022. It requires 30 participants from a single site in order to proceed."
Answered by AI
Are there any available opportunities for participation in this trial?
"According to clinicaltrials.gov, this medical research is actively recruiting participants. The trial was initially posted on May 9th 2022 and has since been updated as recently as the 13th of that same month."
Answered by AI
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