RecruitingNot ApplicableNCT05496491

Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial


Sponsor

Larissa University Hospital

Enrollment

84 participants

Start Date

Aug 30, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment approaches for locally advanced rectal cancer: standard neoadjuvant chemoradiation (chemotherapy plus radiation given before surgery) versus chemoradiation followed by additional consolidation chemotherapy before surgery. The extra chemotherapy cycles may help shrink the tumor further and reduce the chance of spread. **You may be eligible if...** - You are between 18 and 80 years old - You have rectal cancer (adenocarcinoma) confirmed by biopsy - Your tumor is in the lower part of the rectum (within 15 cm of the anal opening) - Your cancer is locally advanced (cT3/T4, or lymph nodes involved) - You are in good general health (WHO 0–1) - Your blood counts, kidney function, and other lab values are within normal ranges **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastases) - Your cancer cannot be surgically removed - You have had prior pelvic radiation or chemotherapy - You have active inflammatory bowel disease - You have a history of serious heart disease (angina, heart attack, heart failure) - You are pregnant or breastfeeding 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

RADIATIONNeoadjuvant Chemoradiotherapy

5-week neoadjuvant radiotherapy regimen (28 x 1.8 Gy) combined with Capecitabine (bid 800 mg/m2, twice daily, on days 1-33-38)

DRUGAdjuvant Chemotherapy

8 cycles of CAPOX (Capecitabine bid 1000 mg/m2, twice daily, day 1-14, every 3 weeks and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively, 12 cycles of folinate, fluorouracil and oxaliplatin (FOLFOX)

DRUGConsolidation Chemotherapy

CAPOX (Capecitabine bid1000 mg/m2 and Oxaliplatin 130 mg/m2, day 1, every 3 weeks) or alternatively FOLFOX


Locations(1)

Department of Surgery, University Hospital of Larissa

Larissa, Greece

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NCT05496491


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