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Anti-cancer agent
Pre-Surgery Chemotherapy for Rectal Cancer
Phase < 1
Waitlist Available
Led By George Chang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Nodal involvement confined to the radiation field
Histologically confirmed diagnosis of rectal adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing how well active surveillance (monitoring cancer growth after treatment) and chemotherapy before surgery work in treating stage II-III rectal cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests the effectiveness of monitoring tumor growth (active surveillance) combined with pre-surgery chemotherapy in treating rectal cancer patients. It aims to determine if delaying surgery after these treatments leads to better outcomes compared to immediate surgery.See study design
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, vomiting, hair loss, fatigue, increased risk of infection due to lowered blood cell counts and potential damage to healthy cells alongside the tumor cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has spread only to lymph nodes that can be targeted by radiation.
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My diagnosis is rectal cancer confirmed by tissue examination.
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My cancer can be measured or seen on scans.
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My rectal cancer can be surgically removed with the goal of curing it.
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I have no known allergies or reactions to standard pelvic chemoradiation treatments.
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My cancer is at Stage II or III, and it's been checked with specific scans.
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I can care for myself and am up and about more than 50% of my waking hours.
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My rectal tumor is within 12 cm of the anal opening, confirmed by a scan or endoscopy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Local tumor regrowth rate
Overall organ preservation rate
Time to surgery or death
Secondary outcome measures
Decision quality assessment determined by European Organization for Treatment and Research of Cancer Quality of Life Questionnaire (EORTC-QLQ30+CR29)
Incidence of adverse events graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Overall survival (OS)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Group II (active surveillance)Experimental Treatment4 Interventions
Participants who have achieved clinical complete response receive active surveillance and consolidated chemotherapy for up to 4 months in the absence of disease progression or unacceptable toxicity. Participants with incomplete response or regrowth of tumor, undergo surgical resection as in Group I.
Group II: Group I (surgical resection)Active Control2 Interventions
Participants who have achieved clinical complete response undergo standard surgical resection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy
2003
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,526 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,329 Total Patients Enrolled
George ChangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis is rectal cancer confirmed by tissue examination.My cancer can be measured or seen on scans.My rectal cancer can be surgically removed with the goal of curing it.I have no known allergies or reactions to standard pelvic chemoradiation treatments.I am not currently receiving treatment for another cancer that would interfere with this trial's treatment.My cancer is at Stage II or III, and it's been checked with specific scans.I have had radiation therapy to my pelvic area before.I cannot or do not want to have a pelvic MRI.My cancer has spread only to lymph nodes that can be targeted by radiation.I can care for myself and am up and about more than 50% of my waking hours.My colorectal cancer is MSI-H.My rectal tumor is within 12 cm of the anal opening, confirmed by a scan or endoscopy.My tumor is causing blockage in my intestines.My rectal cancer has come back.I have been diagnosed with inflammatory bowel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (active surveillance)
- Group 2: Group I (surgical resection)
Awards:
This trial has 1 awards, including:- 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.
Could you please provide information about the enrollment status of this research endeavor?
"Unfortunately, this clinical trial is not presently enlisting for patient participation. The original posting was made on October 31st 2022 and the last update occurred September 22nd 2022; however, there are 311 other trials actively recruiting at present."
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