Clinical trial · Interventional
Capecitabine Versus Bolus 5-Fu Associated to Radiotherapy as Neoadjuvant Treatment for Rectal Cancer.
Estudo Randomizado de Fase II Com Capecitabina Versus 5-Fluorouracil/Leucovorin em Bolus Associados à Radioterapia no Tratamento Neoadjuvante de câncer de Reto Localmente avançado: INCAGI004.
NCT03428529CI-TRIAL-00031614INCAGI004completedPhase 2 / Phase 3ClinicalTrials.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)
A randomized two-arm study comparing preoperative CRT using oral capecitabine versus bolus 5-FU/LV concomitant to external beam radiation (50.5 Gy/28 fractions) for locally advanced rectal cancer. Main outcome was clinical response assessed using MRI and endorectal US 6-8 weeks after CRT. Secondary endpoints were pathological response, adverse effects, sphyncter preservation, quality of life, OS and DFS.
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 Neoplasm Malignant | Rectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5Fluorouracil | Drug | — | UNRESOLVED |
| Capecitabine Oral Product | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine
- description
- Neoadjuvant capecitabine plus RT
- interventionNames
- Drug: Capecitabine Oral Product
- type
- ACTIVE_COMPARATOR
- label
- 5-Flourouracil
- description
- Neoadjuvant 5-Fluorouracil plus RT
- interventionNames
- Drug: 5Fluorouracil
Primary outcomes (1)
- measure
- Clinical downstaging
- timeFrame
- 6-8 weeks after CRT
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: Patients with histologically proven locally advanced rectal cancer (cT3-4 or positive regional lymph node) on endorectal ultrasonography (EUS) or pelvic Magnetic Resonance Imaging (MRI) were qualified for this study. Distance from anal verge (AV) should not exceed 10 cm measured with rigid proctoscopy. Thorax and abdominal computer tomography (CT) exams were taken to rule out distant metastasis. Performance Status ECOG 0-1. Exclusion Criteria: Previous treatment for rectal cancer (RT, chemotherapy or surgical resection). Previous diagnosis of other cancers except nonmelanoma skin cancer. Uncontrolled comorbities including heart failure and miocardial infarction in the previous 6 months. Hepatic insufficiency and renal failure. Pregnancy. Serious neurologic or psyquiatric disturbances that could affect comprehension of informed consent. \-
References
Publications (13)
- BACKGROUNDSaif MW, Hashmi S, Zelterman D, Almhanna K, Kim R. Capecitabine vs continuous infusion 5-FU in neoadjuvant treatment of rectal cancer. A retrospective review. Int J Colorectal Dis. 2008 Feb;23(2):139-45. doi: 10.1007/s00384-007-0382-z. Epub 2007 Oct 2. PMID 17909820
- BACKGROUNDWolff HA, Conradi LC, Beissbarth T, Leha A, Hohenberger W, Merkel S, Fietkau R, Raab HR, Tschmelitsch J, Hess CF, Becker H, Wittekind C, Sauer R, Rodel C, Liersch T; German Rectal Cancer Study Group. Gender affects acute organ toxicity during radiochemotherapy for rectal cancer: long-term results of the German CAO/ARO/AIO-94 phase III trial. Radiother Oncol. 2013 Jul;108(1):48-54. doi: 10.1016/j.radonc.2013.05.009. Epub 2013 Jun 11. PMID 23768685
- BACKGROUNDSawada N, Ishikawa T, Sekiguchi F, Tanaka Y, Ishitsuka H. X-ray irradiation induces thymidine phosphorylase and enhances the efficacy of capecitabine (Xeloda) in human cancer xenografts. Clin Cancer Res. 1999 Oct;5(10):2948-53. PMID 10537364
- BACKGROUNDSchuller J, Cassidy J, Dumont E, Roos B, Durston S, Banken L, Utoh M, Mori K, Weidekamm E, Reigner B. Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patients. Cancer Chemother Pharmacol. 2000;45(4):291-7. doi: 10.1007/s002800050043. PMID 10755317
- BACKGROUNDSuarez J, Vera R, Balen E, Gomez M, Arias F, Lera JM, Herrera J, Zazpe C. Pathologic response assessed by Mandard grade is a better prognostic factor than down staging for disease-free survival after preoperative radiochemotherapy for advanced rectal cancer. Colorectal Dis. 2008 Jul;10(6):563-8. doi: 10.1111/j.1463-1318.2007.01424.x. Epub 2007 Dec 7. PMID 18070184
- BACKGROUNDTulchinsky H, Shmueli E, Figer A, Klausner JM, Rabau M. An interval >7 weeks between neoadjuvant therapy and surgery improves pathologic complete response and disease-free survival in patients with locally advanced rectal cancer. Ann Surg Oncol. 2008 Oct;15(10):2661-7. doi: 10.1245/s10434-008-9892-3. Epub 2008 Apr 4.