Clinical trial · Interventional
Efficacy and Toxicity of Total Neoadjuvant Sandwich Treatment Via Short Course Radiotherapy in the Treatment of Stage II and III Rectal Cancer Patients
- 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)
Several trials showed that total neoadjuvant treatment (TNT) in stage II/III rectal cancer patients had better outcomes when compared with standard neoadjuvant long-course radiotherapy (CRT). Recently, based on the RAPIDO and POLISH II trials a short course radiotherapy (SCRT)-including TNT strategy had better oncologic outcomes and comparable toxicities. Moreover, cost-effectively, an SCRT-including TNT strategy is more convenient than a CRT-based TNT approach. In addition, systemic chemotherapy is often used to treat occult or micrometastatic disease in intermediate and locally advanced rectal cancer. However, the timing of chemotherapy delivery remains a topic of debate. In this context, and since rapid access to radiotherapy treatment is limited, especially in developing countries, a TNT strategy whereby adjuvant chemotherapy is replaced by systemic chemotherapy delivered before and after SCRT according to a "sandwich" treatment can avoid delays in treatment start with equivalent outcomes.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total Neoadjuvant Treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Total neoadjuvant treatment via short course radiotherapy
- description
- Participants in this arm receive 4 cycles of induction chemotherapy CAPEOX (or 5 cycles of FOLFOX6), followed by short course radiotherapy (25 Gy in 5 fractions) delivered via IMRT technique ,then consolidation chemotherapy in the form of : 2 cycles of CAPOX (or, 4 cycles of FOLFOX6). Total mesorectal excision (TME) will be performed for non-metastatic patients within 8-12 weeks of the short course radiotherapy.
- interventionNames
- Radiation: Total Neoadjuvant Treatment
Primary outcomes (1)
- measure
- Pathological complete response
- timeFrame
- 6 months, from induction chemotherapy till total mesorectal excision
- description
- The complete disappearance of all signs of cancer in tissue samples after treatment with chemotherapy and radiation therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * · Patients aged 18 years old till 70 years old. * Pathologically confirmed rectal adenocarcinoma of low or mid rectum (less than 16 cm from the anal verge on endoscopy) * Stage II and stage III by imaging (T3 N any M0 or T1-2 N+ve M0) \[29\]; staged with MRI rectal protocol or EUS. * The disease was staged with CT imaging of chest, abdomen and pelvis pretreatment. * Eastern Cooperative Oncology Group (ECOG) performance status= 0-2. * The following laboratory results are required: absolute neutrophilic count of 1.5 × 10⁹ cells per L or higher, platelet count of 100 × 10⁹ per L or higher, a clinically acceptable haemoglobin level, a creatinine level indicating renal clearance of 50 mL/min or higher, and bilirubin level below 2 mg/dL. * Written informed consent. Exclusion Criteria: * · Previous surgical treatment for rectal cancer or concurrent fistulising inflammatory bowel disease of the rectum. * Surgical or medical inoperability. * Previous pelvic radiotherapy. * Second malignancy within the last 5 years. * Patients with diseases that do not allow receipt of chemotherapy or radiotherapy as grade 3 neuropathy and severe cardiovascular disease.
References
Publications (0)
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