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Tumor Local Excision +Postoperative Adjuvant Chemoradiotherapy for T1-2N0M0 Low/Ultra-Low Rectal Cancer

ConditionRectal Cancer Stage I
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

This study is a single-center, single-arm, prospective clinical trial designed to evaluate the efficacy of local excision followed by postoperative chemoradiotherapy in patients with early-stage low/ultra-low rectal cancer. The study plans to enroll 60 patients with T1-2N0M0 low/ultra-low rectal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, regardless of gender

ECOG performance status 0-1

Biopsy-proven rectal adenocarcinoma

Distal margin of primary tumor ≤8 cm from anal verge

Disqualifiers

Failure to meet the above inclusion criteria

Patients refusing to sign informed consent

Impaired cognitive function or psychiatric disorders

Patients deemed ineligible by investigators

Trial design

Design model

Single group

Treatments tested in this trial

  • Local Tumor Resection

    Procedure/Surgery

    All enrolled patients will first undergo local tumor resection.

  • Radiotherapy

    Radiation

    Pelvic field irradiation 45Gy in 25 fractions plus Local tumor bed boost 5.4Gy in 3 fractions. For patients with positive surgical margins after local resection, a radiotherapy boost (pelvic field 45Gy/25 fractions + tumor bed local boost 14.4Gy/8 fractions) can be given.

  • Chemotherapy

    Drug

    Concurrent oral capecitabine 825 mg/m² twice daily with radiotherapy

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Local Tumor Excision +Postoperative Adjuvant ChemoradiotherapyExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

5-year DFS Rate

Defined as the proportion of subjects who remain free from recurrence, progression, or death for 5 years after completing surgery and adjuvant chemoradiotherapy (estimated as the proportion of event-free patients based on survival curves).

Time frame
5 years

Secondary outcomes

1

5-year Local Recurrence Rate

The proportion of patients who experience tumor recurrence at or near the primary tumor site (within the pelvic region) within 5 years after initial treatment completion.

Time frame
5 years
2

5-year Distant Metastasis Rate

The proportion of patients who develop metastatic disease in distant organs (e.g., liver, lungs, bones, or non-regional lymph nodes) within 5 years after initial treatment.

Time frame
5 years
3

5-year OS

The proportion of patients who remain alive (regardless of disease status) at 5 years after initial diagnosis or treatment initiation.

Time frame
5 years
4

Sphincter Retention Rate

The proportion of patients who successfully avoid permanent colostomy after rectal cancer treatment, maintaining natural anal sphincter function for defecation.

Time frame
1 week after sugery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hebei Medical University Fourth Hospital

Lead sponsor

Source ClinicalTrials.gov
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