Timing of Rectal Cancer Resection After Preoperative Chemoradiotherapy

NCT02441153 | Completed

• 1 other identifier: T4RC North
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot study will take place at Health Sciences North (HSN) in Sudbury. Patients will be identified and screened for inclusion into the study once referred to a general or colorectal surgeon for resection of their rectal cancer. This may occur before or after preoperative chemoradiotherapy (CRT) but randomization will take place after CRT.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Disease-free survival

  The absence of any local recurrence or metastatic disease discovered on physical exam, endoscopy, or imaging

  3 years post surgery

Study Arms (2)

Group 1(Extended Timing)

Surgery will be performed at 10-11 weeks after the completion of chemoradiotherapy.

Other: Extended Timing

Group 2 (Non-extended timing)

Surgery will be performed at 6-7 weeks after completion of chemoradiotherapy.

Interventions

Extended Timing OTHER

Surgery will be performed at 10-11 weeks after completion of chemoradiotherapy.

Group 1(Extended Timing)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients at Health Sciences North who have been referred to a general or colorectal surgeon for resection of their rectal cancer.

You may qualify if:

• Adult patients (\>18 years)
• T3/4N0M0 or TxN+M0 rectal cancer below or at the peritoneal reflection, confirmed on clinical exam, histology, pelvic MRI, and CT chest/abdo
• Patients who have completed a CRT protocol for the above tumor at HSN
• Informed consent given
• Surgical resection with TME planned

You may not qualify if:

• Metastatic disease
• Failure to complete preoperative CRT
• Unable to give free and informed consent
• Unable to comply with the requirements of the study
• Previous malignancy other than nonmelanoma skin cancer, papillary or follicular thyroid cancer
• Inflammatory bowel disease
• Hereditary colorectal cancer

Sponsors & Collaborators

• Health Sciences North Research Institute: lead

Biospecimen

Retention: NONE RETAINED

To maximize the utility of this trial, immunohistochemical staining will be performed on pre-CRT tumor samples to prospectively validate the scoring system proposed by Hur et al. \[28\] The question being whether or not expression of these biomarkers can predict which patients will experience pCR and disease-free survival.

MeSH Terms

Conditions

Rectal Neoplasms

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

Study Officials

• Antonio Caycedo, MD. M.Sc (c). FRCS. FACS

  Health Sciences North

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 12, 2015
• Study Start: March 1, 2016
• Primary Completion: December 25, 2017
• Study Completion: January 25, 2018
• Last Updated: August 20, 2019

Record last verified: 2018-02