Clinical trial · Observational
Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for Low-risk Rectal Cancer
Total Neoadjuvant Therapy Followed by 'Watch and Wait' Approach or Organ Preservation for MRI Stratified Low-risk Rectal Cancer: a Multi-center, Prospective, Single-arm Phase II Trial.
- 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)
Aim: To investigate the safety and efficacy of organ preservation (OP) with watch-and-wait strategy (W\&W) or local excision (LE) in MRI stratified low-risk rectal cancer treated by total neoadjuvant treatment. Meanwhile we will look into the role of ctDNA in the prediction of regrowth and metastasis in the wait and wait process. Methods: Low-risk rectal cancer with following MRI features are recruited: mid-low tumor, mrT2-3b, MRF(-), EMVI(-), differentiation grade 1-3. Patients will receive IMRT 50.6Gy/22f with concurrent capecitabine and 4 cycles of consolidation CAPEOX. Patients with cCR/near-cCR were recommended for 'watch \& wait' approach or local excision (LE). The OPR and sphincter preservation rate (SPR) at 2 years will be analyzed. As the extension of PKUCH-R01, BJCC-R01 trial will upgrade to a multi-center research enrolled 3 other colorectal center in Beijing.
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 |
|---|---|---|---|
| Rectum Cancer | Rectal Carcinoma | ALIAS | 0.90 |
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
- Group A:Clinical complete response (cCR) 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. the age is more than 18 years old and less than 85 years old; * 2\. ECOG score of physical condition is 0-1; * 3\. adenocarcinoma of rectum confirmed by pathology; differentiated into Grade 1-3, i.e. high, medium and low differentiated adenocarcinoma * 4\. the distance from the lower edge of the tumor to the anal edge ≤ 12cm (endoscopy) or to the anorectal ring (ARJ) ≤ 8cm; * 5\. the initial MRI was T2 / T3a / T3B, with negative EMVI and negative CRM. There was no lymph node metastasis outside the ilium, general ilium, obturator and abdominal aorta * 6\. the maximum diameter of tumor ≤ 4cm or the circumferentially invasive area is less than 1 / 3 of intestinal circumference * 7\. no evidence of distant metastasis; * 8\. no history of pelvic radiotherapy; * 9\. no history of surgery or chemotherapy for rectal cancer; * 10\. systemic infection without antibiotic treatment; * 11\. blood routine test: neutrophil absolute value \> 1.5 × 10 9 / L, HGB \> 10.0 g / dl, PLT \> 100 × 10 9 / L; * 12\. blood biochemistry: total bilirubin ≤ 1.5 x ULN, AST ≤ 3 x ULN, ALT ≤ 4 x ULN; * 13\. the patient read and signed the informed consent of the study and agreed to participate in the study; Exclusion Criteria: * 1\. recurrent rectal cancer; * 2\. initial local non resectable rectal cancer (no possibility of R0 whole block resection); * 3\. the creatinine level is 1.5 times higher than the upper limit of normal value; * 4\. have a history of pelvic radiotherapy; * 5\. the patients could not tolerate the enhanced MRI; * 6\. malignant tumors whose survival rate in the past 5 years is significantly lower than that of rectal cancer in our center (excluding well treated basal cell carcinoma, skin squamous carcinoma, small renal carcinoma, breast cancer and thyroid papillary carcinoma); * 7\. in the past 6 months, the patients had arterial embolism diseases, such as angina, MI, TIA, CVA, etc; * 8\. have received other types of anti-tumor or experimental treatment; * 9\. the patients are pregnant or lactating women; * 10\. patients with other diseases or mental disorders may affect their participation in this study;
References
Publications (0)
Data not yet available