Clinical trial · Interventional
Celecoxib, Fluorouracil, and Radiation Therapy in Treating Patients With Stage II or Stage III Rectal Cancer That Can Be Removed By Surgery
Phase II Pilot Study of Pre-Operative Celecoxib (Celebrex) in Combination With Prolonged Venous Infusion 5FU and Radiation Therapy for Patients With Stage II/III Resectable Rectal Cancer
- 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)
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Celecoxib may make tumor cells more sensitive to radiation therapy. Giving celecoxib together with fluorouracil and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving celecoxib together with fluorouracil and radiation therapy works in treating patients with stage II or stage III rectal cancer that can be removed by surgery.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| tumor biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treatment intervention
- interventionNames
- Drug: celecoxib
- Drug: fluorouracil
- Procedure: conventional surgery
- Radiation: radiation therapy
- Procedure: tumor biopsy
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Pathologic complete response rate
- timeFrame
- at time of surgery, day 5
Secondary outcomes (4)
- measure
- Complete resection rate
- timeFrame
- at time of surgery, day 5
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary adenocarcinoma of the rectum * Stage II or III disease * Distal border of tumor must be at or below the peritoneal reflection * Distal border of the tumor must be within 12 cm of the anal verge by proctoscopic exam * Tumor must be clinically resectable * Transmural penetration beyond muscularis propria by transrectal ultrasound * No high-grade obstruction * No evidence of metastatic disease PATIENT CHARACTERISTICS: * Karnofsky performance status 60-100% * WBC ≥ 4,000/mm³ * Platelet count ≥ 150,000/mm³ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other serious medical illness or psychiatric condition that would preclude study treatment * No history of allergy to celecoxib or any other NSAIDs * No history of allergy to sulfonamides * No prior or concurrent malignancy except inactive noninvasive cervical carcinoma or skin cancer (excluding melanoma) or other cancer that has been disease free for ≥ 5 years PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the pelvis * At least 7 days since prior and no other concurrent COX-2 inhibitors or nonsteroidal anti-inflammatory drugs (NSAIDs) * No concurrent warfarin except low-dose warfarin (1 mg/day)
References
Publications (0)
Data not yet available