An interventional study of Radiochemotherapy or radiotherapy in Rectal Cancer, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Status unknown at 1 site in Poland. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2019-03-29.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Not applicable, Interventional, and Treatment
In elderly patients postoperative mortality measured 3-6 months after total mesorectal excision is high. Thus, less toxic treatments may lead to a survival benefit for elderly patients even if a risk of local recurrence is slightly higher compared to the open surgery. The investigators addressed the question whether watch and wait policy is safe in clinical complete responders after (chemo)radiation for elderly patients with small or moderately advanced tumours.
There are two steps of selection. In the first step, the elderly patients with small or moderately advanced tumours who should routinely receive neoadjuvant chemoradiation (or radiation alone in those unfit for chemotherapy) prior to full-thickness local excision using transanal endoscopic microsurgery or prior to total mesorectal excision will be included. In the next step, only patients with clinical complete response obtained 8-10 weeks from completion of (chemo)radiation are selected. Those patients constitute study group and will be observed without further treatment. The remaining patients with residual cancer will proceed to routine management, namely transanal endoscopic microsurgery or total mesorectal excision. Patients undergoing transanal endoscopic microsurgery and having poor response to (chemo)radiation (ypT2-3 disease or positive margin) will proceed to the conversion to total mesorectal excision.
Neoadjuvant chemoradiation: 50 Gy total dose over 5 weeks with 2 Gy per fraction delivered with simultaneous chemotherapy consisting of three cycles of 5-Fu 200 mg/m2 i.v. bolus and leucovorin 100 mg/m2 i.v. short infusion over 2 days given during 1-2, 15-16, and 29-30 days of radiotherapy. Patients unfit for chemotherapy will receive 25 Gy total dose over 5 days with 5 Gy per fraction.
The study hypothesis is that in clinical complete responders after (chemo)radiation treated without initial surgery, the local recurrence rate will be less than 25% and results of the rescue surgery (local and distant recurrence rate) will be not worse (or only slightly worse) than that seen after up-front total mesorectal excision in patients with similar stage of the disease.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 90 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.
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The initial eligibility criteria
There will be two groups of patients:
The final eligibility criterion
Exclusion Criteria:
Patients with complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation.
Radiation: Radiochemotherapy or radiotherapy
50 Gy, 2 Gy per fraction with simultaneous 5-Fu and leucovorin or 5 x 5 Gy for patients unfit for chemotherapy. Patients with complete clinical response 8-10 weeks after radiotherapy will be closely observed and rescue surgery will be performed in a case of local recurrence. Patients with persistent tumour 8-10 weeks after radiotherapy will undergo transanal endoscopic microsurgery or total mesorectal excision. After transanal endosciopic microsurgery, patients with ypT0-1 disease and negative surgical margins will be closely observed and rescue total mesorectal excision will be performed in a case of local recurrence; those with ypT2-3 disease or with positive margin will undergo immediate conversion to total mesorectal excision.
The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence.
Time frame: After 3 years of median follow-up for living patients.
The rate of local recurrence at one year without taking into consideration results of rescue surgery.
Time frame: up to 20 months
The rate of local and distant recurrences after rescue surgery of pelvic recurrence.
Time frame: After 3 years of median follow-up for living patients.
Overall survival at three years.
Time frame: After 3 years of median follow-up for living patients.
Disease-free survival at three years
Time frame: After 3 years of median follow-up for living patients.
Cancer specific survival at three years.
Time frame: After 3 years of median follow-up for living patients.
Evaluation of anorectal function by using self-administered questionnaire in patients without local recurrence.
Time frame: 1 year after treatment
Multivariable analysis of prognostic factors associated with clinical complete response.
Time frame: After 3 years of median follow-up for living patients.
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Maria Sklodowska-Curie National Research Institute of Oncology