Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

Sponsor

Salah Azaïz Cancer Institute (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05868317

Collaborator

(none)

Enrollment

Location

Arm

36.9

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer Locally Advanced	Drug: Chemotherapy With FOLFIRINOX ( 5 Fluorouracil, Oxaliplatine and Irinotecan) Radiation: Radiotherapy	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Actual Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pathologic complete response [1 month after surgery]
no tumor identified in the rectum or associated lymph nodes by final pathology following surgical resection

Secondary Outcome Measures

Disease free survival [3 years]
first relapse after surgery
overall survival [3 years]
death
objective response rate to induction chemotherapy [immediately after completion of 6 cycles of chemotherapy ( each cycle is 14 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Amel Mezlini	Tunis		Tunisia

Sponsors and Collaborators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amel Mezlini, Professor in Medical Oncology, Salah Azaïz Cancer Institute

ClinicalTrials.gov Identifier:

NCT05868317

Other Study ID Numbers:

ISANOX

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 22, 2023