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

Not Applicable

Completed

• Conditions: Radiotherapy; Toxicity Due to Radiotherapy; Rectal Cancer
• Interventions: Radiation: 3-Dimension Conformal Radiation Therapy; Radiation: Intensive Modulated Radiation Therapy

• Registration Number: NCT06160570
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study Start: 2018-10-01
• Status Verified: 2021-01
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3DCRT	3-Dimension Conformal Radiation Therapy	3-Dimension Conformal Radiation Therapy
IMRT	Intensive Modulated Radiation Therapy	Intensive Modulated Radiation Therapy

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related gastrointestinal and urinary adverse events as assessed by CTCAE v5.0	3 months	Acute gastrointestinal and urinary toxicity

Secondary Outcome Measures

Name	Time	Method
Pathological response to chemoradiotherapy	3 months	Pathological response to neoadjuvant chemoradiotherapy was assessed on the surgical specimen.

Trial Locations

Locations (1)

Orly Yariv; 🇮🇱 Petah-tikva, Israel