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

NCT05622357 | Completed Phase 2 DMC

• 1 other identifier: 201617097
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Carcinoma

Keywords

advanced rectal cancer- short course radiation - chemotherapy-surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Local control

  3 years

• Overall survival

  3 years

• Disease free survival

  within 3 years

Study Arms (1)

Short course RT followed by full course of chemotherapy then surgery

EXPERIMENTAL

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

Interventions

short course radiation therapy followed by 6 cycles of CAPOX then surgery RADIATION

Short course RT 5 x5 Gy followed by 6 cycles CAPOX then surgery

Short course RT followed by full course of chemotherapy then surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, الجيزة, 11796, Egypt

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Radiation Oncology

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 18, 2022
• Study Start: March 18, 2018
• Primary Completion: December 20, 2020
• Study Completion: September 1, 2021
• Last Updated: November 18, 2022

Record last verified: 2022-11

Locations

EG (1)