Non-operative Management for Locally Advanced Rectal Cancer

Launched by MOUNT SINAI HOSPITAL, CANADA · Jun 5, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring a non-surgical approach for patients with locally advanced rectal cancer who have successfully responded to a combination of chemotherapy and radiation therapy. The goal is to see if this non-operative management (NOM) is as safe and effective as traditional surgery. Researchers will look at how many patients experience local cancer regrowth and how many require surgery later due to cancer that could not be completely removed.

To participate in this trial, patients must be at least 18 years old, have completed the necessary chemotherapy and radiation treatment, and show signs of a complete response to that treatment within 8 to 10 weeks. The trial is open to all genders and is currently recruiting participants. It’s important to note that individuals with certain conditions, such as other active cancers or those who cannot undergo MRI scans, may not be eligible. Participants will be closely monitored throughout the study to ensure their safety and to gather important data about the effectiveness of this non-surgical approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Completed chemoradiotherapy (CRT) as standard of care \[Stage II and Stage III (T3-T4N0, AnyTN1-2)\]; \[50 Gy (2 Gy x 25 fractions) with 5-FU or capecitabine\]
• • Planned or probable APR
• • ALL criteria for complete clinical response are met between 8 and 10 weeks following completion of CRT
• • 18 years or older
• • Provides written consent
• Exclusion Criteria:
• • Unable to undergo MRI
• • Metastatic disease (including extramesorectal and retroperitoneal lymph nodes)
• • Pregnancy
• • Inflammatory bowel disease
• • More than one primary colorectal cancer
• • Other malignancy within 5 years of treatment for current rectal cancer
• • Unfit for surgery