Skip to main content
OpenTrials
Completed

NCT Number: NCT06160570

IMRT Versus 3DCRT for Locally Advanced Rectal Cancer, Prospective Phase II Study.

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

The standard of care for locally advanced rectal cancer is neoadjuvant chemoradiotherapy. However, acute gastrointestinal (GI) toxicity is common. Some retrospective studies suggested that Intensity Modulated Radiation Therapy( IMRT) reduces acute bowel toxicity compere to 3D conformal radiotherapy (3DCRT).The aim of this prospective phase II study to determine whether the use of IMRT planning in neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer can decrease small bowel irradiation dose compared to commonly used 3D conformal techniques ,and the rate of acute GI toxicity.

Patients (pts) with clinical stage II-III rectal adenocarcinoma were enrolled in a prospective phase II study of preoperative chemoradiation. For each patient two radiation plans were performed: IMRT and 3DCRT. After comparing two DVH (dose volume histogram) plans for organs at risk (OARs), such as small bowel and bladder, pts were treated according to the plan with maximal critical organs sparing. All Patients received 45 Gy in 25 fractions to the rectum and draining lymph nodes, followed by boost to the tumor, with concurrent capecitabine or 5- Fluorouracil .Weekly follow up was performed to assess acute toxicity.

The investigators hypothesize that the use of IMRT in neoadjuvant chemoradiation for locally advanced rectal cancer may reduce the small bowel and bladder irradiated volume and consequently reduce acute toxicity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Prior radiotherapy to pelvis
  • Metastatic disease at diagnosis

Treatment and study plan

Intensive Modulated Radiation Therapy

Radiation

Radiotherapy technique: IMRT

3-Dimension Conformal Radiation Therapy

Radiation

Radiotherapy technique: 3DCRT

Primary outcomes

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

    Time frame: 3 months

    Acute gastrointestinal and urinary toxicity

Secondary outcomes

  1. Pathological response to chemoradiotherapy

    Time frame: 3 months

    Pathological response to neoadjuvant chemoradiotherapy was assessed on the surgical specimen.

Sponsors and collaborators

Lead sponsor

Rabin Medical Center

Other

Registry information

Official study title

Evaluation of Preoperative Chemoradiotherapy Utilizing Intensity Modulated Radiation Therapy (IMRT) When Compared With 3D Conformal Radiotherapy (3DCRT) for Patients With Locally Advanced Rectal Cancer, Prospective Phase II Study.

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.