Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531434
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Establishing Best Treatment Strategy for T4 Esophageal Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Establish Best Treatment Strategy for T4 Esophageal Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to investigate the safety and efficacy of a new treatment approach for T4-stage esophageal cancer which involves chemoradiotherapy after induction chemotherapy The main questions it aims to answer are
Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate
Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer
Participants will
Receive induction chemotherapy for 4 to 8 cycles followed by chemoradiation therapy if downstage to T3
Visit the clinic once every week for checkups and tests
Keep a diary of their symptoms
Does the new induction chemotherapy followed by chemoradiation reduce esophageal perforation rate
Does the new induction chemotherapy followed by chemoradiation increase treatment response rate and patient survival Researchers will analyze the above data to see if the new treatment approach works to treat T4 esophageal cancer
Participants will
Receive induction chemotherapy for 4 to 8 cycles followed by chemoradiation therapy if downstage to T3
Visit the clinic once every week for checkups and tests
Keep a diary of their symptoms
Detailed Description:
The treatment of T4-stage esophageal cancer is challenging because of a high esophageal perforation rate 19 after concurrent chemoradiotherapy This research aims to investigate whether a novel sequential chemoradiotherapy approach can improve the treatment response rate and reduce the incidence of esophageal perforation in participants with T4-stage esophageal cancer The proposed novel treatment strategy involves induction chemotherapy for 4 to 8 cycles It is followed by concurrent chemoradiotherapy if down-stage had been achieved by induction chemotherapy The study will be conducted in two phases starting with a phase I study to determine safety followed by a phase II study to evaluate overall efficacy Expected outcomes include improved treatment response rates and reduced esophageal perforation rates in T4-stage esophageal cancer offering a better treatment option for these patients
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