RecruitingPhase 2NCT05563922

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Early Low Rectal Carcinoma: A Prospective, Exploratory Trial


Sponsor

Shanghai Zhongshan Hospital

Enrollment

56 participants

Start Date

Sep 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery (TEM) or endoscopic local resection for early low rectal cancer(cT 1-3N0M0).Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life (QoL) will also be assessed.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether people with early-stage rectal cancer located close to the anal opening can avoid surgery (and preserve the rectum and bowel function) by using a combination of chemotherapy and radiation before any surgical decision is made. This approach, called total neoadjuvant therapy (TNT), aims to shrink the tumor enough that surgery may not be needed. **You may be eligible if...** - You are 18 or older - You have rectal cancer confirmed by biopsy located within 5 cm of the anal opening - Imaging shows early-stage disease (T1–T3, no lymph node or distant spread) - You strongly want to avoid surgery and preserve bowel function - You have not had any prior treatment for this cancer - You are otherwise suitable for chemoradiotherapy **You may NOT be eligible if...** - You have already received surgery, radiation, or chemotherapy for this cancer - You have other diseases of the colon or rectum - You have a family history of familial polyposis - You have had prior bowel surgery or pelvic radiation - You are pregnant or breastfeeding - Tumors larger than 4 cm, or certain high-risk tumor features, may also disqualify you 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

COMBINATION_PRODUCTTotal Neoadjuvant Chemoradiotherapy

Radiotherapy:45Gy/25F+Boost 50Gy/25F. A total of 45 Gy, 25 fractions of 1.8 Gy, 5 fractions a week CapOx: Capecitabine 1000mg / m² po bid (1-14 days, 21 days a cycle) Oxaliplatin 130mg / m2 igtt(Day 1, 21 days a cycle) TEM or endoscopic local resection


Locations(1)

Fudan University Zhongshan Hospital

Shanghai, Shanghai Municipality, China

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NCT05563922


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