Treating Locally Advanced Rectal Cancer With TAS-102 Chemotherapy Plus Neoadjuvant Radiotherapy
NCT05965531
Summary
The goal of this Phase 2 trial is to evaluate a neoadjuvant treatment mode for locally advanced rectal cancer (LARC), consisting of radiotherapy and concurrent Trifluridine/Tipiracil (TAS-102). The main questions it aims to answer are: (i) whether TAS-102 is effective in treating LARC, when combined with radiotherapy; (ii) whether TAS-102 is safe in combination with radiotherapy. Participants will receive one cycle of TAS-102 chemotherapy and neoadjuvant radiotherapy based on intensity-modulated technique. Then the ones with a possibility of R0 resection will receive radical surgery followed by 6 cycles of adjuvant XELOX (capecitabine plus oxaliplatin) chemotherapy.
Eligibility
Inclusion Criteria: * Pathologically diagnosed rectal adenocarcinoma via biopsy * Pretreatment clinical TNM stage as T3-4N0M0 or T1-4N1-2M0 (UICC TNM staging classification, version 8) * Tumor with proficient DNA mismatch repair confirmed by immunohistochemical analysis * Age between 18 and 75 years old * Karnofsky performance score ≥ 70 * Distance from tumor lower margin to anal verge \< 12 cm Exclusion Criteria: * Inguinal lymph node metastasis * Multiple primary colorectal cancer * Complete obstruction or perforation * Uncontrolled tuberculosis, AIDS or mental diseases * Severe cardiac, renal, hepatic or hematopoietic dysfunctions unsuitable for chemotherapy or radiotherapy * Prior history of other malignancies with 5 years, except cured cervical carcinoma in situ and skin basal cell carcinoma * Prior history of rectal surgery, pelvic radiotherapy or chemotherapy * Pregnant or lactating women * Other situations for which the investigators consider a patient inappropriate to participate
Conditions2
Interventions1
Related trials
- - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Mismatch Repair (MSS/pMMR) Metastatic Colorectal Cancer Without Active Liver Metastases — Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- ROMANCE: "Irinotecan Plus Cetuximab Rechallenge Versus Trifluridine/Tipiracil Plus Bevacizumab in Molecularly Selected Metastatic Colorectal Cancer" — Gruppo Oncologico Italia Meridionale
- Second-line Treatment of Metastatic Colorectal Cancer — Qilu Hospital of Shandong University
- Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma — Federation Francophone de Cancerologie Digestive
- ctDNA-Guided Cetuximab or Bevacizumab Plus Trifluridine/Tipiracil in RAS/BRAF Wild-Type mCRC — Sun Yat-sen University
- A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer — AbbVie
- FOG-001 in Locally Advanced or Metastatic Solid Tumors — Parabilis Medicines, Inc.
- Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas — Inhibrx Biosciences, Inc
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT05965531