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Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.
Chemosensitivity of rectal cancer is not discussed clearly. With previous study, the investigators design this phase II trial to explore the effect of 2 cycles Xelox chemotherapy,so as to explore the early detection of sensitivity of tumor. With inclusion of early,intermediate,and bad stage II/III rectal cancer patients, four cycle of Xelox chemotherapy was given. After the second cycle, MRI,TRUS,DE,endoscopy,and blood DNA test was down to compare with these characteristics of four cycles.so that to detect the data about the chemosensitivity of tumor in the early stage.In future, a phase III trial that explore the effect of radiation or surgery in these chemoresistant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy group | Experimental | patients receive 4 cycles of Xelox |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XELOX | Drug | Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| tumor volume | tumor volume measured by MRI | At the end of Cycle 2 (each cycle is 3 weeks) |
| tumor area in endoscopy | tumor area measured in endoscopy | At the end of Cycle 2 (each cycle is 3 weeks) |
| tumor volume | tumor volume measured by MRI | At the end of Cycle 4 (each cycle is 3 weeks) |
| tumor area in endoscopy | tumor area measured in endoscopy | At the end of Cycle 4 (each cycle is 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| blood DNA test | blood DNA test | At the end of Cycle 2 (each cycle is 3 weeks) |
| blood DNA test | blood DNA test | At the end of Cycle 4 (each cycle is 3 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziqiang Wang, MD | West China Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guoxue Road 37#,West China Hospital | Chengdu | Sichuan | 610041 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24419115 | Background | Schrag D, Weiser MR, Goodman KA, Gonen M, Hollywood E, Cercek A, Reidy-Lagunes DL, Gollub MJ, Shia J, Guillem JG, Temple LK, Paty PB, Saltz LB. Neoadjuvant chemotherapy without routine use of radiation therapy for patients with locally advanced rectal cancer: a pilot trial. J Clin Oncol. 2014 Feb 20;32(6):513-8. doi: 10.1200/JCO.2013.51.7904. Epub 2014 Jan 13. | |
| 25471037 |
| Label | URL |
|---|---|
| NCCN guideline | View source |
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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 |
|---|---|
| C519688 | XELOX |
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a group of patients receive 4 cycle of Xelox chemotherapy, MRI,TRUS, DE,endoscopy, blood DNA test,before, between and after chemotherapy was compared to detect the effect of chemotherapy in 2 cycles.
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| tumor thickness in TRUS | tumor thickness in TRUS | At the end of Cycle 4 (each cycle is 3 weeks) |
| tumor thickness in TRUS | tumor thickness in TRUS | At the end of Cycle 2 (each cycle is 3 weeks) |
| Sclafani F, Cunningham D. Neoadjuvant chemotherapy without radiotherapy for locally advanced rectal cancer. Future Oncol. 2014 Nov;10(14):2243-57. doi: 10.2217/fon.14.127. |
| 25460330 | Result | Birlik B, Obuz F, Elibol FD, Celik AO, Sokmen S, Terzi C, Sagol O, Sarioglu S, Gorken I, Oztop I. Diffusion-weighted MRI and MR- volumetry--in the evaluation of tumor response after preoperative chemoradiotherapy in patients with locally advanced rectal cancer. Magn Reson Imaging. 2015 Feb;33(2):201-12. doi: 10.1016/j.mri.2014.08.041. Epub 2014 Nov 13. |
| 26646794 | Result | Zhang J, Cai Y, Hu H, Lan P, Wang L, Huang M, Kang L, Wu X, Wang H, Ling J, Xiao J, Wang J, Deng Y. Nomogram basing pre-treatment parameters predicting early response for locally advanced rectal cancer with neoadjuvant chemotherapy alone: a subgroup efficacy analysis of FOWARC study. Oncotarget. 2016 Jan 26;7(4):5053-62. doi: 10.18632/oncotarget.6469. |
| 28150022 | Result | Koike J, Funahashi K, Yoshimatsu K, Yokomizo H, Kan H, Yamada T, Ishida H, Ishibashi K, Saida Y, Enomoto T, Katsumata K, Hisada M, Hasegawa H, Koda K, Ochiai T, Sakamoto K, Shiokawa H, Ogawa S, Itabashi M, Kameoka S. Efficacy and safety of neoadjuvant chemotherapy with oxaliplatin, 5-fluorouracil, and levofolinate for T3 or T4 stage II/III rectal cancer: the FACT trial. Cancer Chemother Pharmacol. 2017 Mar;79(3):519-525. doi: 10.1007/s00280-017-3243-7. Epub 2017 Feb 1. |
| 28426108 | Result | Patel UB, Brown G, Machado I, Santos-Cores J, Pericay C, Ballesteros E, Salud A, Isabel-Gil M, Montagut C, Maurel J, Ramon-Ayuso J, Martin N, Estevan R, Fernandez-Martos C. MRI assessment and outcomes in patients receiving neoadjuvant chemotherapy only for primary rectal cancer: long-term results from the GEMCAD 0801 trial. Ann Oncol. 2017 Feb 1;28(2):344-353. doi: 10.1093/annonc/mdw616. |
| 28797063 | Result | Chee CG, Kim YH, Lee KH, Lee YJ, Park JH, Lee HS, Ahn S, Kim B. CT texture analysis in patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy: A potential imaging biomarker for treatment response and prognosis. PLoS One. 2017 Aug 10;12(8):e0182883. doi: 10.1371/journal.pone.0182883. eCollection 2017. |
| 25822672 | Result | Battersby NJ, How P, Moran B, Stelzner S, West NP, Branagan G, Strassburg J, Quirke P, Tekkis P, Pedersen BG, Gudgeon M, Heald B, Brown G; MERCURY II Study Group. Prospective Validation of a Low Rectal Cancer Magnetic Resonance Imaging Staging System and Development of a Local Recurrence Risk Stratification Model: The MERCURY II Study. Ann Surg. 2016 Apr;263(4):751-60. doi: 10.1097/SLA.0000000000001193. |
| 28881920 | Result | Glynne-Jones R, Wyrwicz L, Tiret E, Brown G, Rodel C, Cervantes A, Arnold D; ESMO Guidelines Committee. Rectal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv22-iv40. doi: 10.1093/annonc/mdx224. No abstract available. |
| 34792107 | Derived | Deng X, Wu Q, Bi L, Yu Y, Huang S, He D, Wu B, Gou H, Meng W, Qiu M, He Y, Wang Z. Early response to upfront neoadjuvant chemotherapy (CAPOX) alone in low- and intermediate-risk rectal cancer: a single-arm phase II trial. Br J Surg. 2021 Dec 17;109(1):121-128. doi: 10.1093/bjs/znab388. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |