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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
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Institute - Oncology Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Radiation: Radiochemotherapy or radiotherapy Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. The rate of local recurrence at one year without taking into consideration results of rescue surgery. [ Time Frame: up to 20 months ]
  2. 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. ]
  3. Overall survival at three years. [ Time Frame: After 3 years of median follow-up for living patients. ]
  4. Disease-free survival at three years [ Time Frame: After 3 years of median follow-up for living patients. ]
  5. Cancer specific survival at three years. [ Time Frame: After 3 years of median follow-up for living patients. ]
  6. Evaluation of anorectal function by using self-administered questionnaire in patients without local recurrence. [ Time Frame: 1 year after treatment ]
  7. 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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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The initial eligibility criteria

  • Age ≥70 years or <70 years in patients with ASA 3+
  • Tumour accessible by digital rectal examination
  • Maximal tumour size (usually length) not more than 5 cm
  • Circumferential bowel wall involvement not larger than 60%

There will be two groups of patients:

  1. Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.
  2. Candidates for preoperative (chemo)radiotherapy and total mesorectal excision: cT2 tumors requiring abdominoperineal excision, or cT3 or resectable cT4 (slight involvement of vagina, prostate or seminal vesicles); cN+ is allowed.

The final eligibility criterion

• Complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation

Exclusion Criteria:

  • Distant metastases
  • Fixed tumour on digital rectal examination

Information from the National Library of Medicine

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


Contacts
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Contact: Krzysztof Bujko, Prof. +48 601207466 bujko@coi.waw.pl

Locations
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Poland
M. Sklodowska-Curie Memorial Cancer Center Recruiting
Warsaw, Poland, 02-781
Contact: Krzysztof Bujko, Prof.    +48 601207466    bujko@coi.waw.pl   
Principal Investigator: Krzysztof Bujko, Prof.         
Sponsors and Collaborators
Maria Sklodowska-Curie Institute - Oncology Center
Investigators
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Principal Investigator: Krzysztof Bujko, Prof. M. Sklodowska-Curie memorial Cancer Centre in Warsaw

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Responsible Party: Maria Sklodowska-Curie Institute - Oncology Center
ClinicalTrials.gov Identifier: NCT01863862     History of Changes
Other Study ID Numbers: PGBRJG0113
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Keywords provided by Maria Sklodowska-Curie Institute - Oncology Center:
Rectal cancer
Chemoradiation
Complete pathological response
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Rectal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases