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Completed

NCT Number: NCT05622357

Prospective Study of 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.

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Key information

Conditions

Locally Advanced Rectal Carcinoma

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Institute

Cairo, الجيزة, 11796, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. pathological complete response (pCR)

    Time frame: within 30 days

    No residual disease in surgical specimen

  2. clinical complete response(cCR)

    Time frame: within 30 days

    No residual disease after end of radiation and chemotherapy by examination,imaging and colonoscopy

  3. Sphincter saving surgery

    Time frame: 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 outcomes

  1. Local control

    Time frame: 3 years

    defined as the period calculated from the date of end of treatment to the date of occurrence of loco-regional failure.

  2. Overall survival

    Time frame: 3 years

    defined as period from diagnosis till last follow up or death from any cause

  3. Disease free survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Nov 18, 2022
Registry last updated
Nov 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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