Pre-Surgery Chemotherapy for Rectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This pilot trial studies how well active surveillance and chemotherapy before surgery work in treating participants with stage II-III rectal cancer. Active surveillance involves monitoring participants for additional tumor growth after receiving cancer treatment. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether deferring surgery after active surveillance and chemotherapy will work better in treating participants with stage II-III rectal cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is pre-surgery chemotherapy for rectal cancer safe for humans?
Pre-surgery chemotherapy for rectal cancer has been studied for safety, showing some common side effects like low blood cell counts, diarrhea, and nausea. These side effects are generally manageable, but severe cases can occur, so it's important to be monitored by healthcare professionals during treatment.12345
How is pre-surgery chemotherapy for rectal cancer different from other treatments?
What data supports the effectiveness of the treatment for rectal cancer?
Research shows that chemotherapy, when combined with radiation therapy before surgery, can significantly reduce the risk of cancer coming back in the same area. Even a partial response to this pre-surgery treatment is linked to lower chances of the cancer spreading to other parts of the body.611121314
Who Is on the Research Team?
George J. Chang
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with stage II-III rectal cancer who can undergo standard chemotherapy and are fit enough for potential surgery. They must have measurable disease, be able to use contraception if needed, and provide consent. Excluded are those with bowel obstruction, inability to undergo MRI, certain genetic cancer types like MSI-H, prior pelvic radiation or active treatment for other cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemoradiation
Participants receive chemoradiation treatment to achieve clinical complete response
Active Surveillance and Consolidated Chemotherapy
Participants receive active surveillance and consolidated chemotherapy in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chemotherapy
- Resection of Rectum
Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator