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Induction Chemotherapy Followed by Short Course Radiotherapy in Rectal Cancer

NCT05868317 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-05-22

No results posted yet for this study

Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Salah Azaïz Cancer Institute

    lead OTHER

Principal Investigators

  • Feryel letaief ksontini, A/Prof · Salah Azaiez Institute of oncology

  • Amina Mokrani, A/Prof · Salah Azaiez Institute

  • Mouna Ayadi, A/Prof · Salah Azaiez Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-11-30
Completion
2023-11-30

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05868317 on ClinicalTrials.gov