Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      This study is designed to test the efficacy of tailored operative or non-operative management
      (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity modulated
      radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main purpose of this
      study is to increase organ-preservation rate for low-risk rectal cancer patients.
    

Detailed description: 
      Neoadjuvant chemoradiotherapy (nCRT), total mesorectal excision and adjuvant chemotherapy
      comprise the standard treatment for locally advanced rectal cancer, following which 15-30%
      patients achieved pathological complete response need to receive the removal of rectum
      without residual tumor and suffer significant functional impairment even after sphincter
      preservation. Adjuvant chemotherapy is also questioned for its benefit for prolonged survival
      through the data from various studies. More evidence demonstrated that organ-preservation
      (e.g. non-operative management or local excision) for patients with clinical complete
      response (cCR) or near-cCR following nCRT had similar survival when compared with those
      received standard care.

      This study is designed to investigate the efficacy of neoadjuvant intensity modulated nCRT
      with concurrent capecitabine plus consolidation CapeOX for T2/DWI/Enhanced MRI defined
      cT2-T3b mid-low rectal cancer without threatening mesorectal fascia or extramural vascular
      invasion (EMVI) or mrN2 disease.

      According to the response to treatment evaluated by multi-modal assessment including digital
      exam, T2/DWI/Enhanced MRI, endoscopy and serum CEA test, patients will receive tailored
      operative management like local excision or total mesorectal excision, or non-operative
      management. Intention to treatment was also allowed in this study.

      Firstly, the investigators will observe the organ preservation rate at 2 years. Endpoints for
      organ-preservation like non-regrowth DFS, stoma-free survival and other conventional survival
      outcomes (DFS, OS) would be further collected. The short-term and long-term QoL will be
      measured in all patients.

      . Our baseline data showed the 48% of locally advanced rectal cancers could be downstaged to
      stage ypT0-2N0 following IMRT with concurrent capecitabine. We hypothesize that at least 24%
      of rectal cancers could be candidates for LE or NOM after IMRT and the rectum preservation
      rate will increase to 40% in low-risk rectal cancers by LE or NOM following IMRT plus
      consolidation CapeOX at 2 years. As a superiority design, this study need to recruit 64
      patients to test this hypothesis, with 85% power (exact binomial test for proportions, alpha
      = 5 %, one-sided), If the number of responses is 22 or more, the hypothesis that P <= 0.240
      is rejected. We anticipate about 10 % loss to follow-up, so we will recruit an additional 8
      patients and the study will recruit 72 patients in all.
    

Intervention name(s): Oxaliplatin; Capecitabine; intensity modulated radiotherapy; DRE-Endoscopy-MRI-CEA; Nonoperative Management; Local Excision; Total Mesorectal Excision; Quality of Life Questionnaires
Intervention type(s): Drug; Drug; Radiation; Procedure; Procedure; Procedure; Procedure; Behavioral
Other intervention name(s): OXA; CAPE; IMRT; NOM; LE; TME
Intervention MeSH terms: Capecitabine; Oxaliplatin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Rectal cancer patient who receives primary care in Beijing Cancer Hospital will be selected
        as the candidate for this study.
      
Keywords: Rectal cancer; neoadjuvant; radiotherapy; chemotherapy; organ preservation