NCT06160570

Brief Summary

The goal of this prospective phase II study was to determine whether personalized planning-based nCRT for LARC would indeed decrease small bowel dose, and whether selected plans, specifically prioritizing lower dose to small bowel, would result in lower rates of acute GI toxicity compared with previously reported rates.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
Last Updated

December 7, 2023

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

February 6, 2021

Last Update Submit

December 6, 2023

Conditions

Rectal CancerRadiotherapyToxicity Due to Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment-related gastrointestinal and urinary adverse events as assessed by CTCAE v5.0

    Acute gastrointestinal and urinary toxicity

    3 months

Secondary Outcomes (1)

  • Pathological response to chemoradiotherapy

    3 months

Study Arms (2)

IMRT

ACTIVE COMPARATOR

Intensive Modulated Radiation Therapy

Radiation: Intensive Modulated Radiation Therapy

3DCRT

ACTIVE COMPARATOR

3-Dimension Conformal Radiation Therapy

Radiation: 3-Dimension Conformal Radiation Therapy

Interventions

Intensive Modulated Radiation TherapyRADIATION

Radiotherapy technique: IMRT

IMRT
3-Dimension Conformal Radiation TherapyRADIATION

Radiotherapy technique: 3DCRT

3DCRT

Eligibility Criteria

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

You may qualify if:

  • Patients with locally advanced rectal adenocarcinoma
  • Performance status of 0-2
  • Adequate hematologic, renal, and hepatic function

You may not qualify if:

  • Prior radiotherapy to pelvis
  • Metastatic disease at diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Orly Yariv

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Yulia Kundel, MD

    Davidoff Cancer Center, Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2021

First Posted

December 7, 2023

Study Start

October 1, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

December 7, 2023

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)