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

Primary Purpose

Locally Advanced Rectal Carcinoma

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
short course radiation therapy followed by 6 cycles of CAPOX then surgery
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Rectal Carcinoma focused on measuring advanced rectal cancer- short course radiation - chemotherapy-surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Short course RT followed by full course of chemotherapy then surgery

Arm Description

Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Local control
defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.
Overall survival
defined as period from diagnosis till last follow up or death from any cause
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.

Full Information

First Posted
November 11, 2022
Last Updated
November 11, 2022
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT05622357
Brief Title
Prospective Study of Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Official Title
Prospective Phase II Study of Hypofractionated Short Course Radiation Therapy Followed by Neoadjuvant Chemotherapy and Surgery in Locally Advanced Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
March 18, 2018 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Carcinoma
Keywords
advanced rectal cancer- short course radiation - chemotherapy-surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short course RT followed by full course of chemotherapy then surgery
Arm Type
Experimental
Arm Description
Short course radiation therapy ( 25 Gy/ 5 fractions/ 1 week) , followed by 6 cycles of chemotherapy CAPOX, followed 4-6 weeks by surgery.
Intervention Type
Radiation
Intervention Name(s)
short course radiation therapy followed by 6 cycles of CAPOX then surgery
Intervention Description
Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery
Primary Outcome Measure Information:
Title
pathological complete response (pCR)
Description
No residual disease in surgical specimen
Time Frame
within 30 days
Title
clinical complete response(cCR)
Description
No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy
Time Frame
within 30 days
Title
Sphincter saving surgery
Description
Patients who were deemed abdomino-perineal resection before treatment start & were able to undergo low anterior resection after end of treatment
Time Frame
within 6 months
Secondary Outcome Measure Information:
Title
Local control
Description
defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.
Time Frame
3 years
Title
Overall survival
Description
defined as period from diagnosis till last follow up or death from any cause
Time Frame
3 years
Title
Disease free survival
Description
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.
Time Frame
within 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Cancer Institute
City
Cairo
State/Province
الجيزة
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

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

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