Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer

Launched by PEKING UNIVERSITY CANCER HOSPITAL & INSTITUTE · Jan 6, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to treat low-risk rectal cancer while preserving the organ. The main focus is to see if patients can safely undergo local excision (a type of surgery to remove the tumor) or non-operative management (monitoring the cancer without immediate surgery) after receiving specific treatments, including targeted radiation therapy and chemotherapy. The researchers want to find out how effective these approaches are in keeping the cancer from returning and how well patients tolerate them.

To participate in this trial, individuals need to be between 18 and 85 years old, have been diagnosed with a specific type of rectal cancer, and meet certain health criteria, such as having no major health issues that would complicate treatment. Participants will receive either surgery or will be monitored closely, depending on how they respond to the initial treatment. It's important to note that those with a history of certain cancers, severe kidney problems, or other serious health conditions may not qualify. This study is actively recruiting participants, and anyone interested should discuss it with their healthcare provider to understand the potential benefits and risks.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years and ≤85 years
• • ECOG Performance status 0-1
• • Histologically confirmed diagnosis of adenocarcinoma of the rectum, with tumor differentiation Grade 1-3
• • The distance from down verge of tumor to anal-rectal junction (ARJ) ≤4cm based on MRI, or ≤8 cm based on sigmoidoscopy
• • Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI
• • The maximum diameter of the tumor is ≤4cm or the circumferential invasion range is less than 1/3 of the intestinal circumference
• • No evidence of distant metastases
• • No prior pelvic radiation therapy
• • No prior chemotherapy or surgery for rectal cancer
• • No active infections requiring systemic antibiotic treatment
• • ANC \> 1.5 cells/mm3, HGB \> 10.0 g/dL, PLT \> 100,000/mm3, total bilirubin ≤ 1.5 x ULN, AST≤ 3 x ULN, ALT ≤ 4 x ULN
• • Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.
• Exclusion Criteria:
• • Recurrent rectal cancer
• • Primary unresectable rectal cancer. A tumor is considered unresectable when invading adjacent organs and an en-bloc resection will not achieve negative margins
• • Creatinine level greater than 1.5 times the upper limit of normal
• • Patients who have received prior pelvic radiotherapy
• • Patients who are unable to undergo an MRI
• • Patients with a history of a prior malignancy within the past 5 years, except for well treated basal cell cancer, squamous cell skin cancer, breast cancer, thyroid cancer or small renal cancer, and with DFS \>5 years
• • Patients with a history of any arterial thrombotic event within the past 6 months. This includes angina (stable or unstable), MI, TIA, or CVA
• • Other anticancer or experimental therapy
• • Women who are pregnant or breast-feeding
• • Patients with any other concurrent medical or psychiatric condition or disease which would make them inappropriate candidates for entry into this study.