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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.
Patients harbouring rectal adenocarcinoma T3-4 or N>0 M0 within 10 cm to anal verge were randomized in two treatment arms: (1) capecitabina orally 825mg/m2 bid. 5 days a week for 5 weeks and (2) bolus intravenous 5-FU/LV 350mg/m2/20 mg/m2 D1-D5 on the first and fifth weeks, both combined to pelvic radiotherapy, total dose 50.4 Gy in 28 fractions. Clinical stage before and after CRT was determined using pelvic Magnetic Resonance Imaging (MRI), endorectal ultrasonography (ERUS) and chest, abdominal and pelvic Computer Tomography. Surgery was planned 6 to 8 weeks after CRT. Sphincter preservation was always considered when negative margins were possible. Pathological assessment included stage (TNM 7th Ed.) and Mandard's Tumor Regression Grade (TRG). QOL questionnaires QLQ-C30 and CR38 were completed by patients before and after CRT, after surgery and during follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental | Neoadjuvant capecitabine plus RT |
|
| 5-Flourouracil | Active Comparator | Neoadjuvant 5-Fluorouracil plus RT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine Oral Product | Drug | Neoadjuvant Capecitabine concomitant to external beam radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical downstaging | Clinical downstaging after neoadjuvant treatment | 6-8 weeks after CRT |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological downstaging | Patholgical downstaging after neoadjuvant treatment | 8 weeks after CRT |
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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.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17909820 | Background | Saif 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. | |
| 23768685 | Background | Wolff 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. |
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IPD could be shared if requested after IRB approval.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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1:1 randomization
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| 5Fluorouracil | Drug | Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy |
|
|
| 10537364 | Background | Sawada 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. |
| 10755317 | Background | Schuller 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. |
| 18070184 | Background | Suarez 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. |
| 18389322 | Background | Tulchinsky 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. |
| 16971718 | Background | Bosset JF, Collette L, Calais G, Mineur L, Maingon P, Radosevic-Jelic L, Daban A, Bardet E, Beny A, Ollier JC; EORTC Radiotherapy Group Trial 22921. Chemotherapy with preoperative radiotherapy in rectal cancer. N Engl J Med. 2006 Sep 14;355(11):1114-23. doi: 10.1056/NEJMoa060829. |
| 16479065 | Result | Kim JS, Kim JS, Cho MJ, Yoon WH, Song KS. Comparison of the efficacy of oral capecitabine versus bolus 5-FU in preoperative radiotherapy of locally advanced rectal cancer. J Korean Med Sci. 2006 Feb;21(1):52-7. doi: 10.3346/jkms.2006.21.1.52. |
| 16098249 | Result | Saif MW. Capecitabine versus continuous-infusion 5-fluorouracil for colorectal cancer: a retrospective efficacy and safety comparison. Clin Colorectal Cancer. 2005 Jul;5(2):89-100. doi: 10.3816/ccc.2005.n.020. |
| 15496622 | Result | Sauer R, Becker H, Hohenberger W, Rodel C, Wittekind C, Fietkau R, Martus P, Tschmelitsch J, Hager E, Hess CF, Karstens JH, Liersch T, Schmidberger H, Raab R; German Rectal Cancer Study Group. Preoperative versus postoperative chemoradiotherapy for rectal cancer. N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694. |
| 21475011 | Result | Taylor FG, Quirke P, Heald RJ, Moran B, Blomqvist L, Swift I, Sebag-Montefiore DJ, Tekkis P, Brown G; MERCURY study group. Preoperative high-resolution magnetic resonance imaging can identify good prognosis stage I, II, and III rectal cancer best managed by surgery alone: a prospective, multicenter, European study. Ann Surg. 2011 Apr;253(4):711-9. doi: 10.1097/SLA.0b013e31820b8d52. |
| 20797891 | Result | Tiv M, Puyraveau M, Mineur L, Calais G, Maingon P, Bardet E, Mercier M, Bosset JF. Long-term quality of life in patients with rectal cancer treated with preoperative (chemo)-radiotherapy within a randomized trial. Cancer Radiother. 2010 Oct;14(6-7):530-4. doi: 10.1016/j.canrad.2010.06.017. Epub 2010 Aug 24. |
| 35486228 | Derived | Araujo RO, Vieira FM, Victorino AP, Torres C, Martins I, Guaraldi S, Valadao M, Linhares E, Ferreira CG, Thuler LC. Quality of life in a randomized trial comparing two neoadjuvant regimens for locally advanced rectal cancer-INCAGI004. Support Care Cancer. 2022 Aug;30(8):6557-6572. doi: 10.1007/s00520-022-07059-6. Epub 2022 Apr 29. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |