Clinical trial · Interventional
Preoperative Radiotherapy and Chemotherapy in Patients With Locally Advanced Rectal Cancer
A Phase II Trial of Integrated Preoperative Radiotherapy and Chemotherapy With Oxaliplatin 5-FU and Folinic Acid in Patients With Locally Advanced Rectal Cancer
NCT01013805CI-TRIAL-00028596PROArCTcompletedPhase 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)
The aims of the trial are (1) to determine the tolerability rate in the setting of a multi-centre study and (2) to determine secondary tolerability endpoints, toxicity rates and complete pathologic response rate in patients with locally advanced rectal cancer who are treated with an integrated preoperative radiotherapy with FOLFOX chemotherapy regimen.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| External Beam Radiotherapy | Radiation | — | UNRESOLVED |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Surgical Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Integrated Preoperative Radiotherapy (external beam radiotherapy) and Chemotherapy (Oxaliplatin, Fluorouracil and Leucovorin), then surgical resection.
- interventionNames
- Radiation: External Beam Radiotherapy
- Drug: Oxaliplatin
- Drug: Fluorouracil
- Drug: Leucovorin
- Procedure: Surgical Resection
Primary outcomes (1)
- measure
- Tolerability Rate of patients treated with integrated pre-operative radiotherapy with FOLFOX chemotherapy regimen
- timeFrame
- End of preoperative treatment (11 weeks)
Secondary outcomes (3)
- measure
- Complete pathologic response rate following the completion of treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated and pathologically proven adenocarcinoma of the rectum. * MRI staged T3 or T4, any N. * Lower border of tumour must be within 12 cm of anal verge. * Age greater than or equal to 18 years. * ECOG Performance Status 0-1 (Appendix 2) * Absolute neutrophil count greater than or equal to 1.5 x 109/L, haemoglobin greater than or equal to 90 g/L, and platelets greater than or equal to 100 x 109/L. * Adequate renal function: GFR greater than or equal to 55 mL/min (derived from serum creatinine e.g. using the Cockcroft-Gault formula or measured by radioisotopic techniques). * Bilirubin and ALT less than or equal to 1.5 x upper limit of normal. * No symptomatic peripheral neuropathy greater than or equal to grade 2. * Male or non-pregnant, non-lactating female. Patients on study with reproductive potential, or female partners with reproductive potential, must use an effective contraceptive. * Has provided written informed consent for participation in this trial Exclusion Criteria: * Presence of metastatic disease. * Prior pelvic radiotherapy * Febrile intercurrent illness or infection. * Previous history of unstable angina * Cardiac arrhythmia which in the opinion of the investigator would compromise the safe delivery of protocol treatment * Acute coronary syndrome even if controlled with medication * Myocardial infarction within the last 12 months * Concurrent treatment with other anti-cancer therapy. * Significant medical condition which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities. * Locally recurrent rectal cancer.
References
Publications (0)
Data not yet available
No reference posted for this study.