Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma
Recruiting
Phase 2
Interventional Study
Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 56 (estimated)
- Sponsor
- Shanghai Zhongshan Hospital · Other
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About This Trial
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 an…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Age≥18 years
* cT1-3N0M0 assessed by CT, MRI and ultrasound colonoscopy
* Rectal adenocarcinoma confirmed by biopsy pathology and the lower edge of the lesion was within 5cm from the anal edge
* Patients who have a strong desire to preserve the anus and are willing to accept n…
Contacts