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Trial registered on ANZCTR

Registration number

ACTRN12612000835842

Ethics application status

Approved

Date submitted

4/08/2012

Date registered

8/08/2012

Date last updated

28/05/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Proctectomy with sphincter preservation in very low rectal cancer that traditionally need abdominoperineal resection with permanent colostomy

Scientific title

Effect of changing decision of abdominoperineal resection to sphincter preserving technique in very low rectal cancer after downstaging by neoadjuvant chemoradiation on recurrence and survival

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Low rectal cancer

Condition category

Condition code

Surgery

Surgical techniques

Cancer

Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients with stage II and III low rectal cancer less than 5 cm from anal verge usually need abdominoperineal resection. Preoperative neoadjuvant chemoradiation(54 grays of radiation divided over 5 weeks with chemotherapy by intravenous 5-fu and leucovorin 1 day a week for 5 weeks; 5-FU 425 mg/m2 plus LV 45 mg ) helps in tumor downstaging and downsizing that might help to resect the tumor with safety margin without removing the anal sphincters. Patients with T3, T4 low rectal tumors 5 cm or less from anal verge receive neoadjuvant preoperative chemoradiation. Patient assessment is done 8 weeks after the end of chemoradiation by digital rectal examination and endorectal ultrasound. If there is tumor downsizing that leaves safety margin above the anal sphincters, , then very low anterior resection with coloanal anastomosis is performed (120-180 minutes) . If no sufficient safety margin, intersphincteric resection (120-180 minutes) with coloanal anastomosis is done if the external anal sphincter is not involved (yT2), if the external sphincter was involved so abdominoperineal resection is done and excluded from study.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Drugs

Comparator / control treatment

nil

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Perioperative morbidity assesed by clinical examination of the abdomen to diagnose wound problems, chest x ray and Ultrasound abdomen

Timepoint [1]

1-30 days postoperative

Primary outcome [2]

Perioperative mortailty

Timepoint [2]

1-30 days postoperative

Primary outcome [3]

Tumor recurrence assessed by clinical examination and abdominal CT scan

Timepoint [3]

every 6 months postoperative for 2 years

Secondary outcome [1]

Morbidity and mortality after salvage surgery in case of recurrence by clinical examination of the abdomen to diagnose wound problems, chest x ray and Ultrasound abdomen

Timepoint [1]

1-30 days postoperative after salvage surgery

Secondary outcome [2]

Continence assessed by wexner score

Timepoint [2]

6 months and 1 year postoperative

Eligibility

Key inclusion criteria

Adult male or female 18-80 years
low rectal tumor, 5 cm or less from anal verge
Stage II or III

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Stage IV tumors
fecal incontinence assessed by wexner score

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

20/01/2007

Actual

20/01/2007

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Egypt

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

Egypt

Primary sponsor type

Individual

Name

Khaled Madbouly

Address

Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt

Country

Egypt

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee, University of Alexandria

Ethics committee address [1]

Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt

Ethics committee country [1]

Egypt

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Background:
Multimodality treatment of rectal cancer, with the combination of radiation therapy, chemotherapy, and surgery has become the preferred approach to locally advanced rectal cancer.The considerably high local recurrence rates observed after radical
surgery alone has led to the use and recommendation for additional therapy either before or after surgery for T3/T4 or N1 tumors. In this setting, to avoid overtreatment
of patients with early-stage disease, preoperative treatment with radiation therapy with or without concomitant chemotherapy requires optimal radiological staging because
there is no pathologic confirmation of exact TNM parameters. However, there is a theoretic benefit of exposing unscarred tissue with optimal oxygen delivery to both radiation
and chemotherapy as opposed to postoperative treatment. The results from randomized controlled trials suggest that the neoadjuvant approach seems to be superior for
local disease control, even in the setting of appropriate surgical technique (total mesorectal excision). The use of neoadjuvant chemoradiation therapy (CRT) has resulted in
additional benefits such as reduced toxicity rates, significant tumor downsizing and downstaging, better chance of sphincter preservation, and improved functional results
(compared with postoperative CRT). In a multicenter study of patients undergoing neoadjuvant CRT for clinically stage II disease (staged by either endorectal ultrasound
or magnetic resonance imaging), more than 20% of the patients staged as N0 were found to harbor lymph node metastases in their tumors on pathologic examination.
Considering that these patients underwent neoadjuvant CRT, even greater rates of nodal disease underestimation might be expected. Radical surgery with total mesorectal excision remains the mainstay of treatment of distal rectal cancer and is considered by many to be necessary regardless of tumor
response to neoadjuvant CRT. However, it has been associated with high rates of immediate morbidity and mortality. With very low tumors, abdominoperineal resection sometimes is necessary with the result of permenant colostomy and disturbance of the quality of life. Up till now, many authors believe that the decision of surgery should be set before any change in the tumor by neoadjuvant chemoradiation, however haber-gama who concluded that with complete pathologic response and restrict criteria, it is safe just to follow up the patient without surgery. Changing decision to sphincter preserving technique in patients who have good response to neoadjuvant chemoradiation with downsizing and downstaging is still contraversail.

Aim of the work:
To study the safety of changing decision from abdominoperineal resection to sphincter preserving technique in low rectal tumors after downsizing be neoadjuvant chemoradiation. Aspects of safety will include periperative morbidity, mortality, continence, recurrences and results of salvage surgery after recurrence.

Study design: Patients with stage II and III low rectal cancer less than 5 cm from anal verge usually need abdominoperineal resection. Preoperative neoadjuvant chemoradiation helps in tumor downstaging and downsizing that might help to resect the tumor with safety margin without removing the anal sphincters. Patients with T3, T4 low rectal tumors 5 cm or less from anal verge receive neoadjuvant preoperative chemoradiation.  Patient assessment is done 8 weeks after the end of chemoradiation by digital rectal examination and endorectal ultrasound. If there is tumor downsizing that leaves safety margin above the anal sphincters,  , then very low anterior resection with coloanal anastomosis is performed. If no sufficient safety margin, intersphincteric resection with coloanal anastomosis is done if the external anal sphincter is not involved (yT2), if the external sphincter was involved so abdominoperineal resection is done.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Khaled Madbouly

Address

Faculty of Medicine, University of Alexandria. Kolet el teb Street, Azarita, Alexandria. 21321

Country

Egypt

Phone

+2034802375

Fax

khaled.madbouly@alexmed.edu.eg

Contact person for public queries

Name

Khaled Madbouly

Address

Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt

Country

Egypt

Phone

+20 34802375

Fax

khaled.madbouly@alexmed.edu.eg

Contact person for scientific queries

Name

Khaled Madbouly

Address

Kolet el teb street, Azarita, Faculty of medicine, university of alexandria, Alexandria, 21321, egypt

Country

Egypt

Phone

+20 34802375

Fax

khaled.madbouly@alexmed.edu.eg

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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