Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

May 19, 2023 updated by: Amel Mezlini, Salah Azaïz Cancer Institute

Induction Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) Followed by Short Course Radiotherapy in Locally Advanced Rectal Cancer

A Single-arm phase II trial evaluating induction chemotherapy with FOLFIRINOXm followed by short course radiotherapy (RT) in locally advanced rectal carcinoma

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Total neoadjuvant treatment (TNT) is currently the standard of care in the management of locally advanced rectal cancer since recent studies have shown improved pathological complete response and disease-free survival with this approach. However, survival benefits remain unproven.

Two strategies of TNT are validated so far : induction chemotherapy with FOLFIRINOX followed by long course radio-chemotherapy (RCT) or short course RT (5x5 Gy) followed by consolidation chemotherapy with CAPOX (capecitabine and oxaliplatin) or FOLFOX (5 FU and oxaliplatin) .

The objective of investigators is to evaluate pathological complete response with a new strategy of TNT consisting in induction chemotherapy with FOLFIRINOXm followed by short course RT and a delayed surgery.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • Amel Mezlini

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • World Health Organization (WHO) performance status : 0 or 1
  • Histologically proven rectal adenocarcinoma < 10 cm from anal margin on rectoscopy
  • clinically T3 (cT3) or clinically T4 (cT4) and/ or N+ non metastatic rectal cancer
  • Neutrophil count > 1500 e/mm3
  • Platelet count >100000
  • Hemoglobin > 10 g/dl ( transfusion allowed)
  • Normal bilirubin level
  • Creatinine clearance > 50 ml/mn

Exclusion Criteria:

  • Distant metastases
  • History of chemotherapy or radiotherapy
  • Grade 1 neuropathy
  • Patient undergoing treatment for another cancer
  • Active infection or severe comorbidities contraindicating chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction CT followed by short course RT
Induction chemotherapy with modified 5 fluorouracil, oxaliplatin and irinotecan followed by short course radiotherapy ( 5x5 Gy), then 5 fluorouracil and oxaliplatin based chemotherapy. Surgery will be performed 6 to 8 weeks after completion of RT.
Drug: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan)

Induction chemotherapy with six cycles of modified 5 fluorouracil,oxaliplatin and irinotecan followed by short course radiotherapy (RT) (5x5 Gy), then two cycles of 5 fluorouracil and oxaliplatin based chemotherapy and surgery will be performed 6 to 8 weeks after completion of RT.

After surgery , continuation of chemotherapy with 4 cycles of 5 fluorouracil and oxaliplatin regardless of pathological response

Radiation: Radiotherapy
Short Course Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic complete response
Time Frame: 1 month after surgery
no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection
1 month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease free survival
Time Frame: 3 years
first relapse after surgery
3 years
overall survival
Time Frame: 3 years
death
3 years
objective response rate to induction chemotherapy
Time Frame: immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)
immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salah Azaïz Cancer Institute

Investigators

  • Study Director: Feryel letaief ksontini, A/Prof, Salah Azaiez Institute of oncology
  • Study Chair: Amina Mokrani, A/Prof, Salah Azaiez Institute
  • Study Chair: Mouna Ayadi, A/Prof, Salah Azaiez Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2020

Primary Completion (Actual)

November 30, 2022

Study Completion (Anticipated)

November 30, 2023

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISANOX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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