Clinical trial · Interventional
Study of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk Rectal Cancer
Phase II Randomized Trial of Neoadjuvant Chemotherapeutic Treatment (XELOX) Followed by Chemoradiotherapy (XELOX/RT) and Surgery Versus Chemoradiotherapy Followed by Surgery and Chemotherapy in Patients With High Risk 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)
Primary: * To assess complete pathological response rate of both strategies. Secondary: * Safety profile * To assess downstaging rate of both strategies. * To compare relative dose intensity of oxaliplatin and capecitabine of both strategies * To compare time to progression and overall survival of both strategies.
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 Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin, capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: Oxaliplatin, capecitabine
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: Oxaliplatin, capecitabine
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- from the signature of Informed Consent up to the end of the study
Secondary outcomes (3)
- measure
- Relative dose intensity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with rectal adenocarcinoma. * Operable tumour, confirmed by magnetic resonance of high resolution and / or endorectal echography, or, * Rectal tumour at distal third, or * Tumours spread more than 5 mm in perirectal fat * Functional state ECOG ≤ 2. * Good hematological, hepatic and renal function Exclusion Criteria: * Previous pelvis radiotherapy. * Previous antitumoural chemotherapy * Pregnant or breastfeeding women. * Childbearing women with a positive pregnancy test result at baseline. Menopausal women should not have the period for the last 12 months. * History of any other neoplastic illness within the last 5 years, except for already resolved small cell skin cancer or cervix cancer. * Clinically significant cardiovascular disease * Confirmed peripheral neuropathy. * Gastrointestinal disorders or bad absorption syndrome or non-capable to take oral medication. * Blood disorders. * Intercurrent non-controlled or severe infections. * Patients who have undergone major surgery, open biopsies or with significant trauma lesions within the previous 28 days. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available