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Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy for Rectal Cancer: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Histologically confirmed rectal adenocarcinoma

• cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1

• Multidisciplinary tumor board decision for neoadjuvant treatment

• Tumor distance from the anal verge \<15 cm based on endoscopy or magnetic resonance imaging

• Patient 18 to 80 years old

• General health condition status WHO 0-1

• Absence of co-morbidities that may affect treatment

• Neutrophils \>1,500 / mm3, platelets \>100,000 / mm3, hemoglobin\> 10 g / dL, normal creatinine, and creatinine clearance\> 50 mL / min

• Signed informed consent of the patient

Locations
Other Locations
Greece
Department of Surgery, University Hospital of Larissa
RECRUITING
Larissa
Contact Information
Primary
Konstantinos Perivoliotis, MD
kperi19@gmail.com
2413501000
Backup
George Tzovaras, Prof
gtzovaras@hotmail.com
2413502804
Time Frame
Start Date: 2022-08-30
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 84
Treatments
Experimental: Neoadjuvant Chemoradiotherapy and Consolidation Chemotherapy
The experimental group will receive the standard 5-week neoadjuvant chemoradiotherapy (CRT). Thereafter, all patients will commence consolidation chemotherapy. At the 6th week after the end of CRT, patients will undergo MRI re-staging: In case of non-response (mrTRG 5) they will be submitted immediately to surgery, and, subsequently, excluded from the trial.~In case of response (mrTRG 2-4) they will receive consolidation chemotherapy for the whole waiting period between the end of CRT and surgery - 12 weeks.
Active_comparator: Neoadjuvant Chemoradiotherapy and Adjuvant Chemotherapy
The control group will receive the standard 5-week neoadjuvant chemoradiotherapy regimen. Six weeks after completion the patient will be re-staged with rectal MRI and depending on the response will be operated (TME): immediately in case of non-response (mrTRG 5) or after an additional 6-week delay (overall 12 weeks after the end of chemoradiotherapy) in case of partial response (mrTRG 2-4). Adjuvant chemotherapy will be, also, administered.
Related Therapeutic Areas
Sponsors
Leads: Larissa University Hospital

This content was sourced from clinicaltrials.gov