Online Adaptive Radiation Therapy for Rectal Cancer

July 30, 2023 updated by: Peking Union Medical College Hospital

A Prospective Study to Evaluate Online Adaptive Radiotherapy in Rectal Cancer

In the present study, the investigators will evaluate the efficacy, toxicities, and of online adaptive radiation therapy (ART) for patients with rectal cancer treated with neoadjuvant chemoradiotherapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. ≥18 years old;
  2. Diagnose with rectal cancer;
  3. T3-T4 or N+, and no distant metastasis
  4. Neoadjuvant chemoradiotherapy intended;
  5. Surgery is expected after neoadjuvant therapy;
  6. ECOG score 0-2, expected to lie in the treatment bed for at least half an hour;

Exclusion Criteria:

  1. With contraindications to rectal MRI;
  2. Received surgery, radiotherapy or chemotherapy for rectal cancer;
  3. History of pelvic radiotherapy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online adaptive radiation therapy
Patients receive adaptive radiotherapy therapy and concurrent chemotherapy.
Radiation: Online adaptive radiation therapy
A dose of 45Gy will be delivered to planning target volume (PTV)
Other Names:
  • ART

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute toxicities(CTCA
Time Frame: 3 months for the start of treatment
evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0
3 months for the start of treatment
Response rate after surgery
Time Frame: 3 monsh after treatment
Clinical and pathological complete response and partial response rate after chemoradiotherapy
3 monsh after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic toxicity
Time Frame: 2 years after treatment
evaluated with Radiation Therapy Oncology Group (RTOG)/EORTC late radiation morbidity scoring scheme
2 years after treatment
Dose coverage of target volume (assessed by planing target volume V100%)
Time Frame: Through study completion, an average of five month
Planing target volume V100%, defined as the planing target volume receiving at least 100% of the prescribed dose (V100%), is used to evaluate the dose coverage of target volume.
Through study completion, an average of five month
Margins for clinical target volume(CTV) and gross tumor volume (GTV)
Time Frame: Through study completion, an average of five month
Margins needed in online ART for CTV to planning clinical target volume (PCTV) and GTV to planning gross tumor volume (PGTV) to cover inter/intra-fraction motion
Through study completion, an average of five month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 5, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

May 25, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 22, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-rectal cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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