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

NCT ID: NCT06160570

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer Radiotherapy Toxicity Due to Radiotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMRT

Intensive Modulated Radiation Therapy

Group Type ACTIVE_COMPARATOR

Intensive Modulated Radiation Therapy

Intervention Type RADIATION

Radiotherapy technique: IMRT

3DCRT

3-Dimension Conformal Radiation Therapy

Group Type ACTIVE_COMPARATOR

3-Dimension Conformal Radiation Therapy

Intervention Type RADIATION

Radiotherapy technique: 3DCRT

Interventions

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Intensive Modulated Radiation Therapy

Radiotherapy technique: IMRT

Intervention Type RADIATION

3-Dimension Conformal Radiation Therapy

Radiotherapy technique: 3DCRT

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yulia Kundel, MD

Role: PRINCIPAL_INVESTIGATOR

Davidoff Cancer Center, Rabin Medical Center

Locations

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Orly Yariv

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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IMRT versus 3D to rectum

Identifier Type: -

Identifier Source: org_study_id