Clinical trial · Interventional
Randomized Controlled Study on Optimize Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer
- 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)
Although neoadjuvant chemoradiotherapy has significantly reduced the risk of local recurrence in locally advanced rectal cancer, systemic failure remains a predominant issue probably due to the insufficient control of systemic micro-metastasis in the neoadjuvant treatment. Induction chemotherapy is one of the most studied strategies. However, the efficacy of induction chemotherapy prior to neoadjuvant chemotherapy remains controversial. In our previous study, induction chemotherapy, gap chemotherapy combined with neoadjuvant chemoradiotherapy can improve response rate of rectal cancer patients, but the results have not been confirmed in clinical trial. Whether this new kind of treatment can optimize neoadjuvant therapy for locally advanced rectal cancer or not is still a big problem in clinical practice. This study will focus on how to optimize neoadjuvant chemotherapy.
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 |
|---|---|---|---|
| Advanced Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin) | Drug | — | UNRESOLVED |
| standard chemoradiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard chemoradiotherapy
- description
- Standard chemoradiotherapy (Capecitabine 825mg/m2 combined with radiotherapy )
- interventionNames
- Radiation: standard chemoradiotherapy
- type
- EXPERIMENTAL
- label
- induction and gap chemotherapy
- description
- induction chemotherapy (Capecitabine 2000mg/m2 +oxaliplatine 130mg/m2) + 2 cycles of chemoradiotherapy (Capecitabine 2000mg/m2 +oxaliplatine 100mg/m2 combined with radiotherapy) + gap chemotherapy (Capecitabine 2000mg/m2 + oxaliplatine 130mg/m2)
- interventionNames
- Drug: Induction chemotherapy, Chemoradiotherapy and gap chemotherapy (Capecitabine combine with oxaliplatin)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Pathological confirmed rectal cancer * Clinical stage T3-4 or T any N1 * No metastasis * Distance of tumor is no more than 10cm from anal verge * No previous radiotherapy * Age ranged from 18 to 70 * Eastern Cooperative Oncology Group score system 0-1 Exclusion Criteria: * Clinical stage T1-2 N0 * Distance metastasis * Multiple primary tumor * Cachexy
References
Publications (0)
Data not yet available