Clinical trial · Interventional
Preoperative Combined Radiochemotherapy for Patients With Rectal Carcinoma
Preoperative Combined Radiochemotherapy for Patients With Newly Diagnosed, Primary Operable and Locally Advanced Rectal Carcinoma (cT3, Nx, M0) of the Lower and Middle Rectum
NCT00297141CI-TRIAL-00013268completedPhase 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)
Rate of T-downstaging (Reduction of the T-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine) Evaluation of the toxicity grade III and IV of the therapy scheme
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 |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm (radiochemotherapy)
- description
- single arm study (capecitabine, oxaliplatin)
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Rate of T-downstaging (Reduction of the T-stadium)
- timeFrame
- at the time of final surgery
- description
- surgery following the preoperative combined radiochemotherapy (chemotherapy: Oxaliplatin, Capecitabine)
Secondary outcomes (1)
- measure
- Evaluation of the toxicity grade III and IV of the therapy scheme
- timeFrame
- week 1 to max. week 10
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 - 80 * Biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge) * According to MRI tumor extensions into the perirectal fat tissue (cT3) * No former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma * WHO performance status 0 - 2 * Adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml) * Adequate hepatic function (bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN) * Adequate renal function (creatinin - not more than 1.5 mg/dl) * Women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * Willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study * Life expectancy of at least 3 month * Signed written Informed Consent before recruitment * Exclusion of distant metastases at the time of recruitment Exclusion Criteria: * Former radio- and/or chemotherapy * Tumor of the upper rectum * Any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma) * Peripheral Neuropathy (NCI CTC - not higher than Grade 1) * General contraindication or hypersensitivity against Oxaliplatin and/or Capecitabine * Any other untreated not malign diseases: Cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders * Florid, serious infection at the time of recruitment * Legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance * Evidence of lacking willingness for cooperation of the patient * Pregnant or breast feeding women
References
Publications (1)
- DERIVEDOfner D, Devries AF, Schaberl-Moser R, Greil R, Rabl H, Tschmelitsch J, Zitt M, Kapp KS, Fastner G, Keil F, Eisterer W, Jager R, Offner F, Gnant M, Thaler J; TAKO 05/ABCSG R-02 Trial Investigators. Preoperative oxaliplatin, capecitabine, and external beam radiotherapy in patients with newly diagnosed, primary operable, cT(3)NxM0, low rectal cancer: a phase II study. Strahlenther Onkol. 2011 Feb;187(2):100-7. doi: 10.1007/s00066-010-2182-6. Epub 2011 Jan 21. PMID 21267531