Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2026-01-04 @ 1:12 AM
Study NCT ID:
NCT00991094
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2009-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Collection for the Assessment of Acute and Late Normal Tissue in Patients Treated With Proton Therapy
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Data Collection to Assess Acute and Late Normal Tissue Sequelae in Proton Therapy for Adults
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study collects information on the side effects of proton therapy and detailed information on the proton therapy treatment plan itself. This may help researchers develop methods to predict the risk of side effects for future patients and learn the long-term benefit of proton therapy.
Detailed Description:
PRIMARY OBJECTIVES:
I. To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.
II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.
SECONDARY OBJECTIVES:
I. To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.
II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).
OUTLINE:
Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.
I. To prospectively collect data on acute and late toxicities (including second malignant neoplasms) in patients treated with proton therapy.
II. To collect and store the corresponding radiation dose distribution and imaging data in order to correlate normal tissue response with dose distribution.
SECONDARY OBJECTIVES:
I. To derive and refine dose-response relationships for normal tissue toxicity after proton therapy.
II. To document and compare symptom burden weekly during treatment and twice a month for 3 months after therapy, using the M.D. Anderson Symptom Inventory (MDASI).
OUTLINE:
Patients undergoing standard of care proton therapy are assessed for toxicities weekly during proton treatment, then from 1 to 3 times up to 90 days from the start of treatment and annually thereafter. Patients also complete questionnaires over 15-20 minutes at baseline, weekly during treatment, and every 2 weeks during follow up for up to 3 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: