Phase 2
N=80
Five Fractions of Radiotherapy Followed by Full Dose FOLFOX Chemotherapy as Preoperative Treatment for Rectal Cancer
Rectal Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01060007 ↗Enrolled (actual)
80
Serious AEs
5.1%
Results posted
Feb 2015
Primary outcome: Primary: Rate of T Stage Downstaging — 71 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- External beam radiation (Radiation); Oxaliplatin (Drug); Leucovorin (Drug); 5-FU (Drug); Capecitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of T Stage Downstaging |
71 | — |
| PRIMARY Preoperative Gastrointestinal Morbidity |
7 | — |
| SECONDARY Incidence of Any Late Grade 3 or Higher Morbidity |
16; 21 | — |
| SECONDARY Incidence of Post Chemoradiotherapy Grade 3 or Higher Morbidity |
21 | — |
| SECONDARY Local Control |
95 | — |
| SECONDARY Rate of Overall Control |
89 | — |
| SECONDARY Rate of Locoregional Control |
96 | — |
| SECONDARY Freedom From Disease Relapse |
87 | — |
| SECONDARY Determine Quality of Anorectal Function |
7; 4; 2; 3; 4; 4 | — |
Summary
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.
Eligibility Criteria
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 = 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 = 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
Data sourced from ClinicalTrials.gov (NCT01060007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.