Clinical trial · Interventional
S0304 Induct Chemo Then Chemo-RT in Pts w/Locally Advanced Adenocarcinoma of the Rectum
A Phase II Feasibility Translational Research Trial of Induction Chemotherapy Followed by Concomitant Chemoradiation in Patients With Clinical T4 Rectal Cancer
NCT00070434CI-TRIAL-00007113withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as irinotecan, leucovorin, fluorouracil, and oxaliplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well different regimens of induction chemotherapy followed by chemoradiotherapy work in treating patients with locally advanced adenocarcinoma of the rectum.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Pyridoxine | Drug | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Irinotecan + 5-FU + Leucovorin
- description
- Irinotecan 180mg/m2, IV for 90min on Day 1, q 2 wk x 4 cycles; 5-FU 400 mg/m2, IV bolus on Day 1, q 2 wk x 4 cycles; 5-FU 2.4 g/m2 IV for 46 hours on Day 1, q 2 wk x 4 cycles; Leucovorin 200 mg/m2 IV for 2 hours on Day 1, q 2 wk x4 cycles.
- interventionNames
- Drug: capecitabine
- Drug: fluorouracil
- Drug: irinotecan hydrochloride
- Drug: leucovorin calcium
- Radiation: radiation therapy
- Drug: Pyridoxine
- type
- EXPERIMENTAL
- label
- Irinotecan + Oxaliplatin
- description
- Irinotecan 175mg/m2 IV for 90 minutes on Day 1, q 2wk x4 cycles; Oxaliplatin 85mg/m2 IV for 2 hours on Day 1, q 2wk x4 cycles
- interventionNames
- Drug: capecitabine
- Drug: irinotecan hydrochloride
- Drug: oxaliplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary adenocarcinoma of the rectum * Locally advanced disease (clinical T3-4, N0-2, M0) based on at least 1 of the following criteria: * Clinically fixed tumors on rectal examination with tumor adherent to the pelvic sidewall and/or sacrum * Sciatica attributed to sacral root invasion with CT scan/MRI evidence of the lack of clear tissue plane is considered evidence of fixation * Hydronephrosis on CT scan or intravenous pyelogram of ureteric or bladder invasion by cystoscopy and cytology or biopsy * Invasion into the prostate, vagina, or uterus * Transmural penetration of tumor through the muscularis propria as evidenced by CT scan or MRI and endorectal ultrasound * Distal border of the tumor must be at or below the peritoneal reflection (within 12 cm of the anal verge) by proctoscopic examination * Measurable disease by x-ray, scans, or physical examination * Available tumor tissue to determine molecular profile of the tumor before study treatment * No clinical evidence of high-grade (lumen diameter \< 1 cm) large bowel obstruction unless a diverting colostomy has been performed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * SGOT or SGPT ≤ 2.5 times ULN * Alkaline phosphatase ≤ 2.5 times ULN Renal * See Disease Characteristics * Creatinine ≤ 1.5 times ULN OR * Estimated creatinine clearance \> 50 mL/min Cardiovascular * No significant cardiac disease * No recent myocardial infarction Gastrointestinal * See Disease Characteristics * Able to swallow oral medication * No active inflammatory bowel disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No prior unanticipated severe reaction to study drugs * No known dihydropyrimidine dehydrogenase deficiency * No serious uncontrolled infection * No other serious medical illness that would preclude study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy for colon or rectal cancer Endocrine therapy * Not specified Radiotherapy * No prior pelvic radiotherapy * No prior intra-operative radiotherapy or brachytherapy * No concurrent intra-operative radiotherapy or brachytherapy * No concurrent intensity-modulated radiotherapy Surgery * See Disease Characteristics * See Radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.