Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05868317
• Other study ID #: ISANOX
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: November 1, 2020
• Est. completion date: November 30, 2023

Study information

• Verified date: May 2023
• Source: Salah Azaïz Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Locally Advanced
• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Tunisia	Amel Mezlini	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Salah Azaïz Cancer Institute

Country where clinical trial is conducted

Tunisia, 

References & Publications (2)

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, G — View Citation

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 concomitan — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic complete response	no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection	1 month after surgery
Secondary	Disease free survival	first relapse after surgery	3 years
Secondary	overall survival	death	3 years
Secondary	objective response rate to induction chemotherapy		immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)