Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

NCT03287843 | Completed Results DMC

• 1 other identifier: 17-4.1/13
• Study Type: interventional
• Target: 350
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to compare the outcomes of early versus late surgical resection in patients who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of the participants will undergo surgery before 8 weeks, while the other half will undergo surgery after 8 weeks.

Conditions

Neoplasm, Rectum

Keywords

Locally advanced rectal cancer; Neoadjuvant chemoradiation

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response Rate

  Complete pathological response, defined as the absence of viable tumor cells, may develop after neoadjuvant treatment for rectal cancer. Prognostic factors affecting pathological complete response will be evaluated.

  2 months

Secondary Outcomes (6)

• Completeness of the Mesorectal Dissection

  30 days after surgery

• Tumour Regression Grade

  30 days after surgery

• Surgical Complications

  90 days after surgery

• Recurrence

  5 years after surgery

• Disease-free Survival

  5 years after surgery

Study Arms (2)

Early surgery group

EXPERIMENTAL

İn this arm patients will go under surgery before eight weeks, after neoadjuvant chemoradiation therapy.

Procedure: Total mesorectal excision before 56 days (4-8 weeks)

Late surgery group

EXPERIMENTAL

İn this arm patients will go under surgery after eight weeks, after neoadjuvant chemoradiation therapy.

Procedure: Total mesorectal excision after 56 days (8-12 weeks)

Interventions

Total mesorectal excision before 56 days (4-8 weeks) PROCEDURE

Low anterior resection or abdominoperineal resection

Early surgery group

Total mesorectal excision after 56 days (8-12 weeks) PROCEDURE

Low anterior resection or abdominoperineal resection

Late surgery group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinic stage II-III cancer ( T3- T4 tm or/and N(+) disease )
• Patients with histologically confirmed adenocarcinoma of the rectum
• Tumor distal border located within 15 cm. from anal verge (as measured by rigid rectoscopy)
• Standardized total mesorectal excision surgery
• Tumor must be clinically resectable with curative intent (R0 resection must be most likely)
• Elective operation
• The patient must consent to be in the study and the informed consent must be signed

You may not qualify if:

• Clinic stage I and IV cancer disease
• Patients with malignant disease of the rectum other than adenocarcinoma
• Recurrent rectal cancer
• Emergency cases (Mechanical bowel obstruction, perforation)
• Other previous or concurrent malignancies
• Any contraindication for radiochemotherapy
• Previous chemotherapy or radiotherapy to the pelvis
• Tumor has arisen from chronic inflammatory bowel disease or hereditary polyposis disease
• American Society of Anesthesiologists Score \>3 patients

Sponsors & Collaborators

• Ege University: lead

Related Publications (2)

• Akgun E, Caliskan C, Bozbiyik O, Yoldas T, Doganavsargil B, Ozkok S, Kose T, Karabulut B, Elmas N, Ozutemiz O. Effect of interval between neoadjuvant chemoradiotherapy and surgery on disease recurrence and survival in rectal cancer: long-term results of a randomized clinical trial. BJS Open. 2022 Sep 2;6(5):zrac107. doi: 10.1093/bjsopen/zrac107.

  PMID: 36254732 DERIVED

• Akgun E, Caliskan C, Bozbiyik O, Yoldas T, Sezak M, Ozkok S, Kose T, Karabulut B, Harman M, Ozutemiz O. Randomized clinical trial of short or long interval between neoadjuvant chemoradiotherapy and surgery for rectal cancer. Br J Surg. 2018 Oct;105(11):1417-1425. doi: 10.1002/bjs.10984. Epub 2018 Aug 29.

  PMID: 30155949 DERIVED

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

Results Point of Contact

• Title: Erhan Akgun,MD, Proffessor
• Organization: Ege University Hospital

z.erhan.akgun@ege.edu.tr

+902323905050

Study Officials

• Z.Erhan Akgun, Proffesor

  Ege University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of surgery

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 19, 2017
• Study Start: January 1, 2006
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2022
• Last Updated: March 31, 2022
• Results First Posted: August 29, 2019

Record last verified: 2022-03