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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

NCT03690921 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2023-06-29

Study results available
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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.

Conditions

  • Anal Canal Squamous Cell Carcinoma
  • Stage I Anal Cancer AJCC v8
  • Stage II Anal Cancer AJCC v8
  • Stage IIA Anal Cancer AJCC v8
  • Stage IIB Anal Cancer AJCC v8
  • Stage III Anal Cancer AJCC v8
  • Stage IIIA Anal Cancer AJCC v8
  • Stage IIIB Anal Cancer AJCC v8
  • Stage IIIC Anal Cancer AJCC v8

Interventions

DRUG

Cisplatin

Given IV

DRUG

Fluorouracil

Given IV

RADIATION

Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy

Undergo LET-IMPT

PROCEDURE

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Emma B Holliday · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2022-06-03
Completion
2022-06-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03690921 on ClinicalTrials.gov