Phase 2
Completed N=135
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
Rectal Carcinoma
Source: ClinicalTrials.gov NCT00682786 ↗
Enrolled (actual)
135
Serious AEs
21.4%
Results posted
Sep 2014
Primary outcomePrimary: Rate of Tumor Downstaging Compared With Historical Controls. — 64.4; 64.5 percentage of participants
Summary
Determine if genotype-directed neoadjuvant chemoradiation, using information from the thymidylate synthase promoter polymorphism, result in a greater degree of tumor downstaging in high risk patients compared to historical controls.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Tumor Downstaging Compared With Historical Controls. |
64.4; 64.5 | — |
| SECONDARY Complete Response Rates |
20; 41.9; 18.9; 35.5 | — |
| SECONDARY Define Patient Quality of Life Prior to and Following Neoadjuvant Chemoradiation. |
— | — |
| SECONDARY Determine Patient Fears and Expectations of Pharmacogenetics. |
— | — |
Eligibility Criteria
Inclusion Criteria
- Biopsy proven adenocarcinoma of the rectum
- Lesion evaluated by surgeon and found to be resectable
- Stage T3 or T4 disease on radiography or ultrasound
- 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
- Informed consent signed
- 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 prior malignancy in the past 5 years except: skin cancer or in-situ cervical cancer. However, patients with synchronous adenocarcinomas are eligible provided either (a) the synchronous adenocarcinoma was in a removed pedunculated polyp and did not invade the stalk or (b) the synchronous adenocarcinoma was in a removed polyp that lay within the surgical field (extent of resection would not be changed) or (c) the synchronous adenocarcinoma is smaller than the index rectal cancer and lies completely within the radiation field (clinically favorable second lesion and the extend of radiation and surgery would not be changed).
- Patients with known allergy to 5-fluorouracil or irinotecan
Data sourced from ClinicalTrials.gov (NCT00682786). 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. Informational only — not medical advice.