Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503932
Status:
WITHDRAWN
Last Update Posted:
2012-03-22
First Post:
2007-07-17
Brief Title:
Proton Therapy With Capecitabine for Rectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase III Trial of Proton Therapy With Concurrent Capecitabine for Locally Advanced and Recurrent Rectal Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participant enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of the Phase I portion of this study is to evaluate the safety of a combination of capecitabine and proton therapy for patients with locally advanced or recurrent rectal cancer The maximum tolerated dose MTD will be determined in the Phase I portion of this trial
The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD
Secondary Objectives
1 To evaluate local tumor response in patients treated with the above regimen
2 To evaluate the relapse-free and overall survival in patients treated with the above regimen
3 To evaluate proton dosimetry in patients receiving this treatment
4 To evaluate quality of life in patients receiving this therapy
The primary objective of the Phase II portion of this study is to evaluate the local control rate in patients treated with the above regimen at the MTD
Secondary Objectives
1 To evaluate local tumor response in patients treated with the above regimen
2 To evaluate the relapse-free and overall survival in patients treated with the above regimen
3 To evaluate proton dosimetry in patients receiving this treatment
4 To evaluate quality of life in patients receiving this therapy
Detailed Description:
Proton beams can be used to deliver a high dose of radiation to the treatment area while sparing surrounding normal tissues Capecitabine is a drug that interferes with the growth of cancer cells
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete physical exam Blood about 2 tablespoons will be drawn for routine tests Urine will be collected for routine tests Chest x-rays and computed tomography CT scans of the abdomen stomach area and pelvis will be done Women who are able to have children must have a negative blood or urine pregnancy test
If you are found to be eligible to take part in this study you will receive radiation therapy 1 time a day for 5 days in a row Monday-Friday for 6 -7 weeks 30-35 treatments in all You will take the chemotherapy drug capecitabine by mouth 2 times a day at morning and night on each of the days that you receive radiation therapy These pills will not be taken on Saturday or Sunday These pills should be taken within 30 minutes of eating and with a full glass of water
During the study every week you will have a physical exam and blood about 2 teaspoons will be drawn to check for side effects from chemotherapy and radiation therapy You will be asked about any side effects you are experiencing
You will be evaluated by a surgeon 4-6 weeks after the completion of treatment Those with tumors that can be surgically removed will have surgery to remove the tumor 6-8 weeks after completion of treatment as they would for the standard of care for their disease
You will be taken off study if the disease gets worse or intolerable side effects occur
Two 2 weeks after completing radiation therapy you will have a follow-up visit At this visit you will have a physical exam Blood about 2 teaspoons will be collected for routine tests You will be asked about any side effects you are experiencing Six 6 weeks after completing radiation therapy you will have a follow-up visit At this visit you will have a physical exam chest x-ray and CT scan of your abdomen and pelvis Blood about 2 teaspoons and urine will be collected for routine tests You will be asked about any side effects you are experiencing
After finishing treatment you will have a follow-up visit every 3 months for the first 2 years and every 6 months after that At each visit you will have a physical exam Blood about 2 teaspoons and urine will be collected for routine tests You will have a chest x-ray and CT scan of the abdomen and pelvis You will be asked about any side effects you are experiencing
One 1 year after you finish treatment you will also have a colonoscopy or sigmoidoscopy You will receive a separate consent for these procedures
After participation in the study is over you will have follow-up evaluation as needed for standard of care
This is an investigational study Capecitabine is FDA approved for treating colon cancer after surgery and for treating metastatic colorectal cancer The use of capecitabine with proton beam therapy in this study is investigational About 50 patients will take part in this study All will be enrolled at M D Anderson
Before you can start treatment on this study you will have what are called screening tests These tests will help the doctor decide if you are eligible to take part in this study You will have a complete physical exam Blood about 2 tablespoons will be drawn for routine tests Urine will be collected for routine tests Chest x-rays and computed tomography CT scans of the abdomen stomach area and pelvis will be done Women who are able to have children must have a negative blood or urine pregnancy test
If you are found to be eligible to take part in this study you will receive radiation therapy 1 time a day for 5 days in a row Monday-Friday for 6 -7 weeks 30-35 treatments in all You will take the chemotherapy drug capecitabine by mouth 2 times a day at morning and night on each of the days that you receive radiation therapy These pills will not be taken on Saturday or Sunday These pills should be taken within 30 minutes of eating and with a full glass of water
During the study every week you will have a physical exam and blood about 2 teaspoons will be drawn to check for side effects from chemotherapy and radiation therapy You will be asked about any side effects you are experiencing
You will be evaluated by a surgeon 4-6 weeks after the completion of treatment Those with tumors that can be surgically removed will have surgery to remove the tumor 6-8 weeks after completion of treatment as they would for the standard of care for their disease
You will be taken off study if the disease gets worse or intolerable side effects occur
Two 2 weeks after completing radiation therapy you will have a follow-up visit At this visit you will have a physical exam Blood about 2 teaspoons will be collected for routine tests You will be asked about any side effects you are experiencing Six 6 weeks after completing radiation therapy you will have a follow-up visit At this visit you will have a physical exam chest x-ray and CT scan of your abdomen and pelvis Blood about 2 teaspoons and urine will be collected for routine tests You will be asked about any side effects you are experiencing
After finishing treatment you will have a follow-up visit every 3 months for the first 2 years and every 6 months after that At each visit you will have a physical exam Blood about 2 teaspoons and urine will be collected for routine tests You will have a chest x-ray and CT scan of the abdomen and pelvis You will be asked about any side effects you are experiencing
One 1 year after you finish treatment you will also have a colonoscopy or sigmoidoscopy You will receive a separate consent for these procedures
After participation in the study is over you will have follow-up evaluation as needed for standard of care
This is an investigational study Capecitabine is FDA approved for treating colon cancer after surgery and for treating metastatic colorectal cancer The use of capecitabine with proton beam therapy in this study is investigational About 50 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None