Clinical trial · Interventional
IXO (Irinotecan, Xeloda, Oxaliplatin) in Rectal Cancer
A Phase II Trial of Neoadjuvant IXO Regimen (Irinotecan, Capecitabine [Xeloda], Oxaliplatin) Followed by Combined Modality Capecitabine and Radiation for Locally Resectable Advanced Rectal Cancer
NCT01237665CI-TRIAL-00008267IXOrunknownPhase 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)
This is a prospective open label single-arm, single-institution phase II clinical trial to test the efficacy of neoadjuvant treatment with IXO (Irinotecan, Capecitabine \[Xeloda\], Oxaliplatin) followed by chemoradiotherapy and resection in patients with resectable non-metastatic primary rectal cancer of stage cT3-T4 N0-N2.
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 |
|---|---|---|---|
| IXO regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IXO regimen
- description
- single-group
- interventionNames
- Drug: IXO regimen
Primary outcomes (1)
- measure
- Pathological complete response (pCR)
- timeFrame
- 26 weeks
- description
- To test the efficacy of neoadjuvant treatment with IXO followed by chemoradiotherapy and surgical resection, evaluated as histological therapy-induced tumour regression, assessed by the rate of pathological complete response (pCR) at the primary tumor site (pT0)
Secondary outcomes (8)
- measure
- Objective Response
- timeFrame
- 12 weeks and 18 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: General * Pathologically confirmed rectal adenocarcinoma * T3 or T4 or N1 (node ≥1 cm on short axis) adenocarcinoma of the rectum. * ECOG performance status equal or less than 1 * Male and female patients, aged ≥ 18 years and ≤ 80 years * Written informed consent * Adequate haematological, liver, renal function Resectability * Patients categorized as having resectable locally advanced cancer * Favorable general condition Exclusion Criteria: Resectability * Diagnosis of metastatic disease * Clear indication of involvement of pelvic wall(s), on imaging. * Peritoneal carcinomatosis, portal vein occlusion, ascites, non-regional lymph nodes * Histology other than adenocarcinoma * Obstructed rectal carcinoma without defunctionalizing colostomy Prior treatment * Previously undergone treatment for this disease * Prior chemotherapy for colorectal cancer * Prior chemotherapy for other malignancies in past 12 months * Prior radiotherapy other than skin cancer * Concomitant use of St John's Wort * Treatment with any other investigational agent * Current use of full-dose of warfarin for therapeutic Other conditions * Confirmed or suspected brain metastases * History or evidence of CNS disease * Past or current history of other malignancies * Clinically significant cardiovascular disease * Evidence of bleeding diathesis or coagulopathy * Known hypersensitivity to any of the study drugs * Serious, non-healing wound, ulcer or bone fracture * Major surgical procedure or significant traumatic injury within 28 days prior to treatment * Disease or condition that contraindicates the use of an investigational drug * Life expectancy less than 5 years * Inability or unwillingness to comply with the protocol * Neuropathy ≥ Gr.2 * History of ulcerative colitis or Crohn's disease * Pelvic abscess or perforated pelvic carcinoma Pregnancy / Contraception * Pregnancy or lactation * Positive serum pregnancy test within 7 days of starting study treatment
References
Publications (0)
Data not yet available
No reference posted for this study.