Clinical trial · Interventional
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
A Phase II Evaluation of Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
NCT01060007CI-TRIAL-00026342completedPhase 2Results postedClinicalTrials.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)
To determine if short course radiotherapy followed by chemotherapy can maintain morbidity at or below levels reported with concurrent 5FU, oxaliplatin, and radiotherapy, while maintaining response rates comparable to what would be expected with radiotherapy and concurrent chemotherapy.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| External beam radiation | Radiation | — | UNRESOLVED |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant radiation followed by FOLFOX
- description
- Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week. FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks). If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days.
- interventionNames
- Radiation: External beam radiation
- Drug: Oxaliplatin
- Drug: Leucovorin
- Drug: 5-FU
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Rate of T Stage Downstaging
- timeFrame
- Mean number of weeks before surgery 17.3 (SD +/- 2.9 weeks)
- description
- T stage downstaging is defined as clinical pretreatment American Joint Committee on Cancer T stage (cT) being greater than pathologic T stage at surgery (ypT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Biopsy proven adenocarcinoma of the rectum * Patient evaluated by surgeon and found to be a potential surgical candidate. Since the primary objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible. * Clinical evidence of T3 or T4 disease. This can be by imaging studies (see or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions) * Karnofsky Performance Status at \>60 * Laboratory criteria: * Absolute neutrophil count \>= 1.5 K * Platelets \>= 100 K * Total Bilirubin \<= 2.0; * SGOT and Alkaline Phosphatase \<= 2 x upper limit of normal * Creatinine \< 2.0 * Hemoglobin \>= 8.0 * Informed consent signed * Tumor measurable in at least one dimension. This may be, e.g. length and/or width measured endoscopically or on digital rectal examination, and maximum rectal wall thickness determined by imaging studies. * Estimated longevity at least 12 months * Patients with distant metastatic disease will be eligible if they satisfy all other conditions Exclusion Criteria: * Pregnant women, children \< 18 years, or patients unable to give informed consent * Patients with a past history of pelvic radiotherapy. * Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer * Patients with known allergy/intolerance to 5FU, Leucovorin, Oxaliplatin, Capecitabine * Prior chemotherapy for colorectal cancer. * Grade \>= 2 peripheral neuropathy * Any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU (oral capecitabine if 5FU is unavailable), Leucovorin, Oxaliplatin chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.