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

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06160570
Enrollment
75
Registered
2023-12-07
Start date
2018-10-01
Completion date
2021-01-31
Last updated
2023-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiotherapy, Rectal Cancer, Toxicity Due to Radiotherapy

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.

Detailed description

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.

Interventions

RADIATIONIntensive Modulated Radiation Therapy

Radiotherapy technique: IMRT

RADIATION3-Dimension Conformal Radiation Therapy

Radiotherapy technique: 3DCRT

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with treatment-related gastrointestinal and urinary adverse events as assessed by CTCAE v5.03 monthsAcute gastrointestinal and urinary toxicity

Secondary

MeasureTime frameDescription
Pathological response to chemoradiotherapy3 monthsPathological response to neoadjuvant chemoradiotherapy was assessed on the surgical specimen.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026