Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer

The goal of this clinical trial is to investigate total neoadjuvant therapy (TNT) using short course radiation therapy (SCRT) followed by full course of chemotherapy then surgery in locally advanced rectal cancer. The main questions it aims to answer are:

• Is total neoadjuvant treatment in this design safe & tolerable?
• Impact of this design on treatment related outcomes in terms of pathological and clinical responses.

Study Overview

• Status: Completed
• Conditions: Locally Advanced Rectal Carcinoma
• Intervention / Treatment: Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgery

Detailed Description

Patients will be assigned to an experimental arm in which preoperative short course 5 x 5 Gy radiation therapy is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin) and surgery within 4-6 weeks

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • الجيزة
    • Cairo, الجيزة, Egypt, 11796
      • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histopathological proof of rectal adenocarcinoma.
• Tumors located within 15 cm and not less than 4 cm from anal verge.
• Age: ≥ 18 years.
• Locally advanced resectable rectal cancer (cT3/4 N0- Any T N+ve).
• ECOG Performance Status: 0-2.

Exclusion Criteria:

• Non-epithelial rectal malignancy such as sarcoma or lymphoma.
• Unresectable tumors in which surgery will never be possible even if substantial tumor downsizing is seen.
• Recurrent rectal cancer.
• Previous history of malignancy within the last 5 years.
• Previous pelvic irradiation.
• Psychiatric or addictive disorder that would preclude study therapy.
• Concurrent uncontrolled medical conditions.
• Pregnancy or breast feeding.
• Any contraindication to surgery.
• Extensive peripheral neuropathy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short course RT followed by full course of chemotherapy then surgery; Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.	Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgery; Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pathological complete response (pCR)	No residual disease in surgical specimen	within 30 days
clinical complete response(cCR)	No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy	within 30 days
Sphincter saving surgery	Patients who were deemed abdomino-perineal resection before treatment start & were able to undergo low anterior resection after end of treatment	within 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local control	defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.	3 years
Overall survival	defined as period from diagnosis till last follow up or death from any cause	3 years
Disease free survival	defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure or distant failure, whichever comes first.	within 3 years

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2018
• Primary Completion (Actual): December 20, 2020
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: advanced rectal cancer- short course radiation - chemotherapy-surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: 201617097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No