Clinical trial · Interventional
Genotype-directed Neoadjuvant Chemoradiation for Rectal Carcinoma
NCT00682786CI-TRIAL-00029809completedPhase 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)
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.
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 Carcinoma | Rectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5FU | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Radiation | Radiation | — | UNRESOLVED |
| Surgery of resectable lesions | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Good Risk (Thymidylate Synthase (TYMS)*2/*2, *2/*3, *2/*4)
- description
- Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
- interventionNames
- Drug: 5FU
- Radiation: Radiation
- Procedure: Surgery of resectable lesions
- type
- EXPERIMENTAL
- label
- Poor Risk (Thymidylate Synthase (TYMS)*3/*3, *3/*4)
- description
- Radiation 45 Gy in 25 fractions to the pelvis. 5FU CIVI 225 mg/m2/day by CIVI during radiation Irinotecan 50 mg/m2 IV weekly for 5 doses. Surgery 6-10 weeks after completion of preoperative radiation if disease has become resectable.
- interventionNames
- Drug: 5FU
- Radiation: Radiation
- Procedure: Surgery of resectable lesions
- Drug: Irinotecan
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.