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Anti-metabolites
Chemoradiation with Targeted Therapy for Rectal Cancer
Phase 2
Waitlist Available
Led By Imtiaz A. Malik, MD
Research Sponsored by Loma Linda Oncology Medical Group, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Able to tolerate major surgery
T3 or T4 tumor or nodal involvement by endorectal ultrasound or CT scan or MRI
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving capecitabine and panitumumab together with radiation therapy with or without irinotecan hydrochloride before surgery in treating patients with rectal cancer.
Who is the study for?
This trial is for adults with localized rectal cancer who can undergo major surgery. They should not have other cancers unless disease-free for 5 years, no serious infections or heart issues in the past year, and cannot be HIV or hepatitis positive. Participants need normal organ function tests and must use effective contraception.Check my eligibility
What is being tested?
The study is testing how well patients respond to chemotherapy drugs capecitabine and irinotecan hydrochloride, combined with panitumumab (a monoclonal antibody) and radiation therapy before surgery. The goal is to shrink the tumor before it's removed.See study design
What are the potential side effects?
Possible side effects include reactions to the monoclonal antibody like skin rash or infusion reactions, chemotherapy-related issues such as nausea, diarrhea, fatigue, low blood counts leading to increased infection risk, and radiation-induced skin irritation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fit for major surgery.
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My cancer is advanced, affecting deeper tissues or lymph nodes.
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My cancer is a type of rectal cancer confirmed by lab tests.
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I am fully active or can carry out light work.
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
1-year survival rate
2-year survival rate
Disease-free survival
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Who is running the clinical trial?
Loma Linda Oncology Medical Group, Inc.Lead Sponsor
Imtiaz A. Malik, MDPrincipal InvestigatorLoma Linda Oncology Medical Group, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fit for major surgery.I don't have the UGT1A1*28 genetic mutation.My cancer is advanced, affecting deeper tissues or lymph nodes.I have not received any treatments targeting the EGFr protein.It has been over 4 weeks since I last took sorivudine or brivudine.I am not taking any long-term immune-weakening medications.I am not taking cimetidine currently.My cancer has not spread to distant parts of my body.I have been cancer-free from any other invasive cancer for over 5 years.I can swallow pills and do not have issues with nutrient absorption.My cancer is a type of rectal cancer confirmed by lab tests.My tumor is near the sphincter but hasn't spread to it, and I might need major surgery.I do not have any serious infections right now.I haven't had serious heart problems in the last year.I have not had chemotherapy or radiotherapy for rectal cancer.I have not had radiation therapy to my pelvic area.It has been over 28 days since my last major surgery.It has been over 14 days since my last minor surgery.I am fully active or can carry out light work.I have never been diagnosed with interstitial lung disease.I have not taken any EGFr inhibitor medications.
Research Study Groups:
This trial has the following groups: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.
What are the risks associated with this treatment plan?
"While there is some evidence of this treatment's safety, it is still in Phase 2 trials and has not been proven effective. Consequently, our team rates its safety at a 2."
Answered by AI
Are there any available positions for participants in this trial?
"According to the website, this clinical trial has not been recruiting patients for some time now. The study was first posted on 7/1/2009 and was last updated on 1/9/2014. However, there are plenty of other opportunities to participate in medical research, as 927 other studies are currently seeking enrolment."
Answered by AI
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