CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Cisplatin +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03690921
NCT03690921Phase 2Completed

Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial

M.D. Anderson Cancer Center·interventional·Posted Oct 1, 2018·Updated Jun 29, 2023

In Brief

A Phase 2 clinical trial evaluating Cisplatin, Fluorouracil, and 3 other interventions for Anal Canal Squamous Cell Carcinoma and 8 related conditions. Completed, enrolled 8 participants across 1 site.

Detailed Summary

This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer. LET-IMPT is a type of radiation therapy that uses high energy proton "beamlets" to "paint" the radiation dose into the target and may help to kill tumor cells and shrink tumors. Giving LET-IMPT and standard chemotherapy may work better in treating patients with anal canal squamous cell cancer.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 1, 2018
Enrollment StartNov 8, 2018
Primary CompletionJun 3, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.8 years ago

Interventions

Cisplatindrug

Given IV

Fluorouracildrug

Given IV

Linear Energy Transfer-Optimized Intensity Modulated Proton Therapyradiation

Undergo LET-IMPT

Quality-of-Life Assessmentprocedure

Ancillary studies

Questionnaire Administrationother

Ancillary studies