Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

NCT05868317 | Unknown Phase 2 DMC

• 1 other identifier: ISANOX
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer; Locally Advanced

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection

  1 month after surgery

Secondary Outcomes (3)

• Disease free survival

  3 years

• overall survival

  3 years

• objective response rate to induction chemotherapy

  immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)

Study Arms (1)

Induction CT followed by short course RT

EXPERIMENTAL

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); Radiation: Radiotherapy

Interventions

Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) DRUG

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

Induction CT followed by short course RT

Radiotherapy RADIATION

Short Course Radiotherapy

Induction CT followed by short course RT

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Salah Azaïz Cancer Institute: lead

Study Sites (1)

Amel Mezlini

Tunis, Tunisia

Location

Related Publications (2)

• Fernandez-Martos C, Pericay C, Aparicio J, Salud A, Safont M, Massuti B, Vera R, Escudero P, Maurel J, Marcuello E, Mengual JL, Saigi E, Estevan R, Mira M, Polo S, Hernandez A, Gallen M, Arias F, Serra J, Alonso V. Phase II, randomized study of concomitant chemoradiotherapy followed by surgery and adjuvant capecitabine plus oxaliplatin (CAPOX) compared with induction CAPOX followed by concomitant chemoradiotherapy and surgery in magnetic resonance imaging-defined, locally advanced rectal cancer: Grupo cancer de recto 3 study. J Clin Oncol. 2010 Feb 10;28(5):859-65. doi: 10.1200/JCO.2009.25.8541. Epub 2010 Jan 11.

  PMID: 20065174 RESULT

• Conroy T, Bosset JF, Etienne PL, Rio E, Francois E, Mesgouez-Nebout N, Vendrely V, Artignan X, Bouche O, Gargot D, Boige V, Bonichon-Lamichhane N, Louvet C, Morand C, de la Fouchardiere C, Lamfichekh N, Juzyna B, Jouffroy-Zeller C, Rullier E, Marchal F, Gourgou S, Castan F, Borg C; Unicancer Gastrointestinal Group and Partenariat de Recherche en Oncologie Digestive (PRODIGE) Group. Neoadjuvant chemotherapy with FOLFIRINOX and preoperative chemoradiotherapy for patients with locally advanced rectal cancer (UNICANCER-PRODIGE 23): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2021 May;22(5):702-715. doi: 10.1016/S1470-2045(21)00079-6. Epub 2021 Apr 13.

  PMID: 33862000 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Drug Therapy; folfirinox; Fluorouracil; Oxaliplatin; Irinotecan; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Camptothecin; Alkaloids

Study Officials

• Feryel letaief ksontini, A/Prof

  Salah Azaiez Institute of oncology

  STUDY DIRECTOR

• Amina Mokrani, A/Prof

  Salah Azaiez Institute

  STUDY CHAIR

• Mouna Ayadi, A/Prof

  Salah Azaiez Institute

  STUDY CHAIR

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: Professor in Medical Oncology

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 22, 2023
• Study Start: November 1, 2020
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2023
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)