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

Phase 2

Completed

• Conditions: Locally Advanced Rectal Carcinoma
• Interventions: Radiation: short course radiation therapy followed by 6 cycles of CAPOX then surgery

• Registration Number: NCT05622357
• Lead Sponsor: National Cancer Institute, Egypt

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

Study Timeline

• Study Start: 2018-03-18
• Primary Completion: 2020-12-20
• Study Completion: 2021-09-01
• Status Verified: 2022-11
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Short course RT followed by full course of chemotherapy then surgery	short course radiation therapy followed by 6 cycles of CAPOX 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Local control	3 years	defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.
Overall survival	3 years	defined as period from diagnosis till last follow up or death from any cause
Disease free survival	within 3 years	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.

Trial Locations

Locations (1)

National Cancer Institute; 🇪🇬 Cairo, الجيزة, Egypt