Organ Preservation in Elderly Patients With Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT01863862|
Recruitment Status : Recruiting
First Posted : May 29, 2013
Last Update Posted : March 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Radiation: Radiochemotherapy or radiotherapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Organ Preservation in Elderly Patients With Rectal Cancer: a Prospective Observational Study|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Clinical complete responders.
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. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863862
|Contact: Krzysztof Bujko, Prof.||+48 firstname.lastname@example.org|
|M. Sklodowska-Curie Memorial Cancer Center||Recruiting|
|Warsaw, Poland, 02-781|
|Contact: Krzysztof Bujko, Prof. +48 601207466 email@example.com|
|Principal Investigator: Krzysztof Bujko, Prof.|
|Principal Investigator:||Krzysztof Bujko, Prof.||M. Sklodowska-Curie memorial Cancer Centre in Warsaw|