Organ Preservation in Elderly Patients With Rectal Cancer

NCT01863862 | Unknown

• 1 other identifier: PGBRJG0113
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Chemoradiation; Complete pathological response

Outcome Measures

Primary Outcomes (1)

• The final three-year rate of local and distant recurrences taking into consideration results of rescue surgery for pelvic recurrence.

  After 3 years of median follow-up for living patients.

Secondary Outcomes (7)

• The rate of local recurrence at one year without taking into consideration results of rescue surgery.

  up to 20 months

• The rate of local and distant recurrences after rescue surgery of pelvic recurrence.

  After 3 years of median follow-up for living patients.

• Overall survival at three years.

  After 3 years of median follow-up for living patients.

• Disease-free survival at three years

  After 3 years of median follow-up for living patients.

• Cancer specific survival at three years.

  After 3 years of median follow-up for living patients.

Study Arms (1)

Clinical complete responders.

EXPERIMENTAL

Patients with complete clinical response obtained 8 weeks after chemoradiation or 10 weeks after short-course radiation.

Radiation: Radiochemotherapy or radiotherapy

Interventions

Radiochemotherapy or radiotherapy RADIATION

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.

Clinical complete responders.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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:
• Candidates for preoperative (chemo)radiotherapy and local excision: tumour ≤3 cm, non-polipoid cT1, or cT2 or borderline cT3, cN0.
• 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

You may not qualify if:

• Distant metastases
• Fixed tumour on digital rectal examination

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead

Study Sites (1)

M. Sklodowska-Curie Memorial Cancer Center

Warsaw, 02-781, Poland

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms; Pathologic Complete Response

Interventions

Chemoradiotherapy; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Krzysztof Bujko, Prof.

  M. Sklodowska-Curie memorial Cancer Centre in Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krzysztof Bujko, Prof.

CONTACT

+48 601207466; bujko@coi.waw.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2013
• First Posted: May 29, 2013
• Study Start: August 1, 2012
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 29, 2019

Record last verified: 2019-03

Locations

PL (1)