RecruitingPhase 2NCT05228431

Modified Sandwich Therapeutic Regimen for Locally Advanced Rectal Cancer

Single Arm and Phase II Clinical Trial of a Sandwich Regimen as XELOX Regimen and Capecitabine Alternate Administration Combined With Preoperative Intensity Modulated Radiation Therapy for pMMR Locally Advanced Rectal Cancer


Sponsor

Zhen-Hai Lu

Enrollment

121 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

In the treatment of locally advanced rectal cancer, the short-term and long-term efficacy of the traditional sandwich regimen has not reached satisfactory efficacy. For this reason, the concept of reducing the dose of postoperative chemotherapy or directly moving forward the full amount of postoperative chemotherapy was proposed, which is called total neoadjuvant therapy (TNT). However, TNT also includes the high toxicity of oxaliplatin in the whole process and the long time interval between the end of radiotherapy and the operation, which leads to fibrosis of the surrounding tissue, which increases the difficulty of surgical resection and makes it difficult to ensure good surgical specimen quality. In addition to this, there are issues that may increase the risk of potential disease progression in patients with poor treatment withdrawal. Therefore, appropriately reducing the intensity of chemotherapy and controlling the total duration of preoperative neoadjuvant therapy during radiotherapy is expected to alleviate the side effects of neoadjuvant therapy. Here, the investigators synthesized the characteristics of TNT and sandwich regimens and proposed a XELOX regimen and capecitabine alternate administration combined with preoperative intensity modulated radiation therapy.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified treatment approach (called a sandwich regimen) for locally advanced rectal cancer that combines chemotherapy, radiation, and surgery in an optimized sequence — with the aim of shrinking the tumor more effectively before removal. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with rectal cancer (adenocarcinoma) confirmed by pathology - Your cancer is at clinical stage T3-T4 or has spread to nearby lymph nodes (N1) - Surgery to remove all cancer (R0 resection) appears achievable - You have no evidence of cancer spread to distant organs - You have not previously received radiotherapy, surgery, or chemotherapy for this cancer **You may NOT be eligible if...** - You have metastatic (stage IV) rectal cancer - You have unresolved bowel obstruction - You are outside the 18–75 age range - You have had prior cancer treatments for this rectal cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXELOX

Starting from the first day of radiotherapy (set as day 0), the patient received a total of 4 courses of XELOX chemotherapy on days -42, -21, 42, and 63, including oxaliplatin 130 mg/m2, intravenous administration, d1, repeat every 3 weeks; and capecitabine 1000mg/m2, twice daily, d1-d14, repeat every 3 weeks.

DRUGCapecitabine monotherapy

During radiotherapy (Monday to Friday), capecitabine was administered at 1650 mg/m2/d, twice a day.

RADIATIONRadiation

The TV is expanded by 6-7mm to form PTV1, and the CTV is expanded by 6-7mm to form PTV2. The dose of PTV1 was 50Gy/25 times/35 days, and the dose of PTV2 was 45Gy/25 times/35 days, 5 times/week for a total of 5 weeks.


Locations(1)

Zhenhai Lu

Guangzhou, Guangdong, China

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NCT05228431