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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorLarissa University Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Distant metastases

Non-resectable cancer

Contraindications for the administration of chemotherapy

Previous pelvic radiotherapy or chemotherapy

Trial design

Treatments tested in this trial

  • Neoadjuvant Chemoradiotherapy
  • Adjuvant Chemotherapy
  • Consolidation Chemotherapy

Treatment groups

84 Participants
are divided into 2 treatment groups

Sponsors and collaborators