Preoperative Chemoradiotherapy With CApecitabine and Temozolomide in MGMT Silenced, MSS, Locally Advanced RecTal Cancer

In patients with locally advanced rectal cancer (LARC), preoperative chemo-radiotherapy (CTRT) is considered the standard of care. Preoperative CTRT approach often results in a significant tumor downstaging and local control, with evidence of complete pathological response (pCR) rate of about 15% in high volume institutions. In high-risk LARC a new strategy called total neoadjuvant therapy (TNT) has emerged, in which systemic chemotherapy with fluorouracil and oxaliplatin (RAPIDO trial) or with the triplet FOLFIRINOX (as was used in the PRODIGE 23 study) is incorporated before or after the adm

Trial Details

NCT ID

NCT05136326

Phase

PHASE2

Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status

RECRUITING

Cancer Type

Colorectal Cancer

Interventions

• External-beam radiation
• Capecitabine
• Temozolomide

Locations (sample)

• Milan, Italy|45.46427,9.18951

Key Eligibility Criteria

• Written informed consent to study procedures;
• Willing and able to comply with the protocol;
• Age ≥ 18 years;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;

For full eligibility, visit ClinicalTrials.gov.

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