Neoadjuvant chemotherapy first, followed by chemoradiation and then surgery, in the management of locally advanced rectal cancer.
Andrea Cercek, Karyn A Goodman, Carla Hajj...
https://pubmed.ncbi.nlm.nih.gov/24717570Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID05054959
Induction Versus Consolidation Chemotherapy in Total Neoadjuvant Therapy of Locally Advanced Rectal Cancer With High Risk of Recurrence (ICONA Study)
Led by Institute of Oncology Ljubljana · Updated on 2021-09-23
62
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the best sequence of treatments in total neoadjuvant therapy (TNT) for people with locally advanced rectal cancer who have a high risk of the disease coming back. This Phase 2 study compares two approaches: one using consolidation chemotherapy after chemoradiotherapy and another using induction chemotherapy before and after chemoradiotherapy. The goal is to find which method leads to the highest rate of complete remission and better long-term outcomes. Participants receive chemoradiation using advanced techniques like intensity-modulated irradiation with a targeted boost to the tumor. One group receives 6 cycles of CAPOX chemotherapy after chemoradiation, while the other group receives 4 cycles of CAPOX before and 2 cycles after chemoradiation. CAPOX includes capecitabine taken orally and oxaliplatin given intravenously in specified doses and cycles, with treatment tailored based on tumor staging. During the study, participants will have regular check-ups and scans to monitor treatment effects and disease status. Researchers will assess complete remission two weeks after finishing TNT and follow survival, disease recurrence, and local control over three years. The study involves ongoing monitoring to understand the long-term benefits and risks of each treatment sequence for rectal cancer patients.
CONDITIONS
Brief Title
Consolidation Versus Induction Chemotherapy in Total Neoadjuvant Therapy of Rectal Cancer With High Risk for Recurrence
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically proven rectal adenocarcinoma
- No distant metastases on CT scan (M0 disease)
- At least one high risk factor for disease recurrence identified on MR imaging: T4 tumor (cT4), N2 disease (cN2), extramural venous invasion (cEMVI+), positive lateral lymph nodes, or tumor/lymph node distance to mesorectal fascia 1 mm or less (cMRF+)
- Capacity to give informed consent
- Willingness to attend regular check-ups during and after treatment
You will not qualify if you...
- History of previous irradiation in the pelvic area
- Absolute contraindications for MR imaging
- Inability to reliably exclude distant metastases
- Presence of synchronous cancer
- Chronic inflammatory bowel disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 15 to 18 weeks depending on chemotherapy regimen
Participants receive total neoadjuvant therapy (TNT) for rectal cancer, including chemoradiotherapy combined with chemotherapy cycles either as consolidation or induction chemotherapy.
Weekly visits for chemoradiotherapy and chemotherapy administration
Follow-up
Duration - Up to 3 years
Participants are monitored for treatment response and long-term outcomes including survival and disease recurrence.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Institute of Oncology
Ljubljana, Slovenia, 1000
Actively Recruiting
Loading map...
Research Team
V
Vaneja Velenik, PhD
M
Miha Orazem, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Total neoadjuvant therapy vs standard therapy of locally advanced rectal cancer with high-risk factors for failure.
Mojca Tuta, Nina Boc, Erik Brecelj...
https://pubmed.ncbi.nlm.nih.gov/33643528Total neoadjuvant treatment of locally advanced rectal cancer with high risk factors in Slovenia.
Mojca Tuta, Nina Boc, Erik Brecelj...
https://pubmed.ncbi.nlm.nih.gov/31652124Randomized Phase II Trial of Chemoradiotherapy Plus Induction or Consolidation Chemotherapy as Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer: CAO/ARO/AIO-12.
Emmanouil Fokas, Michael Allgäuer, Bülent Polat...
https://pubmed.ncbi.nlm.nih.gov/31150315Induction chemotherapy, chemoradiotherapy and consolidation chemotherapy in preoperative treatment of rectal cancer - long-term results of phase II OIGIT-01 Trial.
Danijela Golo, Jasna But-Hadzic, Franc Anderluh...
https://pubmed.ncbi.nlm.nih.gov/30210040Acute Toxicity and Tumor Response in Locally Advanced Rectal Cancer After Preoperative Chemoradiation Therapy With Shortening of the Overall Treatment Time Using Intensity-Modulated Radiation Therapy With Simultaneous Integrated Boost: A Phase 2 Trial.
Jasna But-Hadzic, Franc Anderluh, Erik Brecelj...
https://pubmed.ncbi.nlm.nih.gov/27727065