Organ preservation approach for low-risk rectal cancer
Organ Preservation First Strategy and Intentional Watch and Wait for MRI Defined Low-risk Rectal Cancer
This study is testing if a less invasive treatment option can safely help patients with low-risk rectal cancer keep their organs after receiving a specific type of radiation and chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Beijing, Haidian District) |
| Trial ID | NCT06209099 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of local excision (LE) or non-operative management (NOM) in patients with MRI-defined low-risk rectal cancer after receiving neoadjuvant intensity-modulated radiotherapy combined with capecitabine and consolidation CapeOX. The study will assess the organ-preservation rate and determine whether LE or NOM is a viable treatment option for these patients. Participants will be assigned to radical surgery, LE, or NOM based on their response to the initial treatment. The trial focuses on patients who meet specific MRI criteria for low-risk rectal cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 85 with histologically confirmed low-risk adenocarcinoma of the rectum.
Not a fit: Patients with advanced rectal cancer, distant metastases, or those who have undergone prior treatments for rectal cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for radical surgery in patients with low-risk rectal cancer, preserving their quality of life.
How similar studies have performed: Other studies have explored organ preservation strategies in rectal cancer, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Haidian District
- Peking University Cancer Hospital & Institute — Beijing, Haidian District, China (Recruiting)
Study contacts
- Study coordinator: Xiaokang Lei, M.D.
- Email: lxkpku@163.com
- Phone: +8610-88196086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.