NCT05911789

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 5, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

August 1, 2023

Status Verified

May 1, 2023

Enrollment Period

10 months

First QC Date

May 25, 2023

Last Update Submit

July 30, 2023

Conditions

Rectal Cancer

Keywords

rectal canceradaptive radiation therapy

Outcome Measures

Primary Outcomes (2)

  • Acute toxicities(CTCA

    evaluated with Common Terminology Criteria for Adverse Events (CTCAE) 5.0

    3 months for the start of treatment

  • Response rate after surgery

    Clinical and pathological complete response and partial response rate after chemoradiotherapy

    3 monsh after treatment

Secondary Outcomes (3)

  • Chronic toxicity

    2 years after treatment

  • Dose coverage of target volume (assessed by planing target volume V100%)

    Through study completion, an average of five month

  • Margins for clinical target volume(CTV) and gross tumor volume (GTV)

    Through study completion, an average of five month

Study Arms (1)

Online adaptive radiation therapy

EXPERIMENTAL

Patients receive adaptive radiotherapy therapy and concurrent chemotherapy.

Radiation: Online adaptive radiation therapy

Interventions

Online adaptive radiation therapyRADIATION

A dose of 45Gy will be delivered to planning target volume (PTV)

Also known as: ART
Online adaptive radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 22, 2023

Study Start

August 5, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

August 1, 2023

Record last verified: 2023-05