Clinical trial · Interventional
Neoadjuvant Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer
Efficacy and Safety of Neoadjuvant Chemo-chemoradio-chemo Sequential Therapy in Locally Advanced Mid/Low Rectal Cancer: a Phase II Trial
NCT02022852CI-TRIAL-00013251unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Compared curative effect，safety and compliance between concurrent chemoradiotherapy and chemo-chemoradio-chemo sequential therapy in locally advanced mid/low rectal cancer.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| XELOX | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiotherapy
- description
- Capecitabine neoadjuvant concurrent radiochemotherapy and XELOX adjuvant therapy
- interventionNames
- Drug: Capecitabine
- type
- EXPERIMENTAL
- label
- Sequential therapy
- description
- XELOX/capecitabine/XELOX neoadjuvant chemo-chemoradio-chemo sequential therapy and XELOX adjuvant therapy
- interventionNames
- Drug: XELOX
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathology rectal adenocarcinoma * Distal distance of tumor from anal verge \< 10cm * TNM staging T3-4N0-2(MRI) * No distant metastasis * Karnofsky score≥70 * Female patients need contraception during the test * Postmenopausal women for at least 12 months, expect pregnancy possibility * Patients did not receive chemotherapy, radiotherapy in any form before * No other severe related diseases (such as other tumor, severe cardiac and central nervous system diseases, etc.) Exclusion Criteria: * Be treated by radiotherapy, chemotherapy or tumor biological therapy before * Received immunosuppressive therapy (including corticosteroids) * Participated in other clinical trial(s) in 1 month * With malignant tumor of colon * Peripheral neuropathy (WHO I level and above) * Neurological or psychiatric abnormalities affecting cognition , including central nervous system metastasis * Severe allergies or allergic history * Severe pulmonary or heart disease * Pregnant or lactation or refuse contraception during the test * Suffering other malignant tumors in past
References
Publications (0)
Data not yet available
No reference posted for this study.