Early Evaluation of Chemosensitivity for Low/Intermediated-risk Mid-low Stage II/III Rectal Cancer

NCT03666442 | Completed Phase 2

• 1 other identifier: RC-CT-2018
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Cancer

Keywords

rectal cancer；; neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (4)

• blood DNA test

  At the end of Cycle 2 (each cycle is 3 weeks)

• blood DNA test

  At the end of Cycle 4 (each cycle is 3 weeks)

• tumor thickness in TRUS

  At the end of Cycle 4 (each cycle is 3 weeks)

• tumor thickness in TRUS

  At the end of Cycle 2 (each cycle is 3 weeks)

Study Arms (1)

chemotherapy group

EXPERIMENTAL

patients receive 4 cycles of Xelox

Drug: XELOX

Interventions

XELOX DRUG

Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks

chemotherapy group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• endoscopy and biopsy verified rectal cancer within 12cm from anal verge;
• primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;
• age from 20-75;
• with informed consent;

You may not qualify if:

• refuse the further treatment after recruiting;
• diagnosis of peritoneal metastasis in the surgery;

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Guoxue Road 37#,West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (10)

• 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.

  PMID: 24419115 BACKGROUND

• 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.

  PMID: 25471037 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.

  PMID: 25460330 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.

  PMID: 26646794 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.

  PMID: 28150022 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.

  PMID: 28426108 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.

  PMID: 28797063 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.

  PMID: 25822672 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.

  PMID: 28881920 RESULT

• 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.

  PMID: 34792107 DERIVED

Related Links

• NCCN guideline

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

XELOX

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Ziqiang Wang, MD

  West China Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: September 11, 2018
• Study Start: June 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)