Clinical trial · Observational
Tailored Operative or Non-operative Management for Low-risk Rectal Cancer After Intensive Neoadjuvant Treatment
Tailored Operative or Non-operative Management for MRI Defined Low-risk Rectal Cancer Following Neoadjuvant Intensity Modulated Radiotherapy With Concurrent Capecitabine Plus Consolidation CapeOX.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to test the efficacy of tailored operative or non-operative management (NOM) for MRI defined low-risk rectal cancer following neoadjuvant intensity modulated radiotherapy with concurrent capecitabine plus consolidation CapeOX. The main purpose of this study is to increase organ-preservation rate for low-risk rectal cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| DRE-Endoscopy-MRI-CEA | Procedure | — | UNRESOLVED |
| intensity modulated radiotherapy | Radiation | — | UNRESOLVED |
| Local Excision | Procedure | — | UNRESOLVED |
| Nonoperative Management | Procedure | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Quality of Life Questionnaires | Behavioral | — | UNRESOLVED |
| Total Mesorectal Excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group A:Clinical complete response (cCR)
- description
- Patients who achieve cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Nonoperative Management(NOM).
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Radiation: intensity modulated radiotherapy
- Procedure: DRE-Endoscopy-MRI-CEA
- Procedure: Nonoperative Management
- Behavioral: Quality of Life Questionnaires
- label
- Group B:Near-cCR
- description
- Patients who achieve near-cCR when restaged by DRE-Endoscopy-MRI-CEA at 16 weeks following intensity modulated radiotherapy(IMRT) plus consolidation CapeOX(Capecitabine+Oxaliplatin) will receive Local Excision(LE) or Nonoperative Management(NOM).
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Radiation: intensity modulated radiotherapy
- Procedure: DRE-Endoscopy-MRI-CEA
- Procedure: Nonoperative Management
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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) ≤8cm based on MRI, or ≤12cm based on sigmoidoscopy; * Clinical Stage T2 or T3a or T3b and EMVI (-) and MRF (-) and extra-mesorectal metastatic lymph node (-) based on MRI * 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 ≤ 3 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.
References
Publications (1)
- DERIVEDWang L, Zhang XY, Zhao YM, Li SJ, Li ZW, Sun YS, Wang WH, Wu AW; Rectal Cancer Cooperative Group of Peking University Cancer Hospital. Intentional Watch and Wait or Organ Preservation Surgery Following Neoadjuvant Chemoradiotherapy Plus Consolidation CAPEOX for MRI-defined Low-risk Rectal Cancer: Findings From a Prospective Phase 2 Trial (PKUCH-R01 Trial, NCT02860234). Ann Surg. 2023 Apr 1;277(4):647-654. doi: 10.1097/SLA.0000000000005507. Epub 2022 Jun 29. PMID 35766394