Clinical trial · Observational
Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy
- 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 investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- ITNT group
- description
- Patients who achieve a good response after total neoadjuvant therapy and receive organ preservation strategy
Primary outcomes (1)
- measure
- 1-year organ preservation rate
- timeFrame
- 1 year after completion of neoadjuvant radiotherapy
- description
- defined as the proportion of the following two groups among the total study population：① Patients evaluated as having a clinical complete response (cCR) or near cCR at 8 weeks after radiotherapy who choose a watch-and-wait strategy and maintain cCR for 1 year; ② Patients evaluated as having a cCR or near cCR at 8 weeks after radiotherapy who ultimately undergo local excision and remain recurrence-free for 1 year without requiring salvage surgery.
Secondary outcomes (2)
- measure
- 1-year metastasis-free survival
- timeFrame
- 1 year after total neoadjuvant therapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18-80 years; no restriction on sex. * Histologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing pMMR/MSS status. * Tumor characteristics assessed by chest-abdominal CT, rectal ultrasound, and MRI meeting all of the following criteria: 1. The lower edge of the tumor is ≤5 cm from the anal verge as measured by digital rectal examination or MRI; 2. Clinical stage cT1-3abN0-1M0 (for cT1N0, patients suitable for endoscopic resection are excluded); 3. MRF (-) (\>1 mm), EMVI (±); 4. Negative lateral lymph nodes and \<7 mm in size; 5. Maximum tumor length ≤5 cm; 6. Tumor circumference involvement ≤2/3. * After receiving at least two cycles of induction chemotherapy with the XELOX regimen, MRI assessment shows treatment response (tumor length reduced by ≥30% compared with baseline). * Completion of total neoadjuvant therapy (TNT), including long-course chemoradiotherapy and consolidation chemotherapy (radiotherapy: 25-28 fractions; chemotherapy: 6-8 cycles). * (For the prospective cohort) Provision of written informed consent for participation in this observational study. Exclusion Criteria: * Patients with a history of, or concurrent, other malignant tumors (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix); * Patients with severely incomplete clinical data that preclude effective evaluation; * (For the prospective cohort) Patients who refuse to provide written informed consent.
References
Publications (0)
Data not yet available