Chemotherapy + Immunotherapy for Rectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a treatment for cancer patients undergoing surgery. It uses low dose chemotherapy and radiation to weaken the cancer, followed by immunotherapy drugs to help the immune system fight any remaining cancer cells.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take any other chemotherapy, investigational products, or biologic or hormonal therapy for cancer treatment while participating in this trial.
Is the combination of chemotherapy and immunotherapy safe for rectal cancer treatment?
How is the drug Cyclophosphamide used in treating rectal cancer different from other treatments?
The combination of chemotherapy and immunotherapy using Cyclophosphamide for rectal cancer is unique because it integrates an immune system-boosting approach with traditional chemotherapy, which is not a standard treatment for rectal cancer. This approach may offer a novel way to enhance the body's ability to fight cancer cells, potentially improving outcomes compared to existing treatments that primarily focus on chemotherapy and radiation.26789
What data supports the effectiveness of the drugs Cyclophosphamide, Cytoxan, Neosar, Endoxan, Tremelimumab, and Durvalumab for rectal cancer?
Research shows that neoadjuvant chemotherapy (treatment given before the main treatment) is effective in reducing local recurrence and distant metastasis in rectal cancer, and combining chemotherapy with radiation therapy is more effective than surgery alone. However, the specific effectiveness of the drugs Cyclophosphamide, Cytoxan, Neosar, Endoxan, Tremelimumab, and Durvalumab for rectal cancer has not been directly established in the provided studies.2691011
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive sub-ablative radiation, with Arm A also receiving low dose cyclophosphamide
Surgery
Participants undergo surgery following radiation treatment
Adjuvant Immunotherapy
Participants receive consolidation tremelimumab-durvalumab after surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cyclophosphamide
- Tremelimumab, Durvalumab
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Ontario Institute for Cancer Research
Collaborator
OICR
Collaborator