Total Meso-rectal Excision Versus Transanal Local Excision Followed by Radiotherapy for T2N0M0 Distal Rectal Cancer

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years.

Histologically confirmed adenocarcinoma by preoperative biopsy.

Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.

Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.

Disqualifiers

History of other malignant tumors within the past 5 years.

Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.

Multiple primary colorectal tumors.

Pregnant or breastfeeding women.

Trial design

Design model

Parallel

Treatments tested in this trial

  • transanal local excision following radiotherapy

    Procedure/Surgery

    transanal local excision following radiotherapy

  • TME

    Procedure/Surgery

    Total mesorectal excision

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: transanal endoscopic microsurgery followed by radiotherapyExperimental treatment 1 intervention
Group B: total mesorectal excisionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

local recurrance rate

Time frame
3 years

Secondary outcomes

1

3-years overall survival rate

Time frame
3 years
2

3-year disease-free survival

Time frame
3 years
3

3-year mortality rate

Time frame
3 years
4

postoperative quality of life

Measured by Quality of Life Questionnaire "EORTC QLQ-C30 (version 3)"

Time frame
30 days

Other outcomes

Sponsors and contacts

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