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

• Sponsor: West China Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03666442
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Arm: 1
• Actual Duration (Months): 43
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Drug: XELOX	Phase 2

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Evaluation of Chemosensitivity for Low-risk Stage II/III Rectal Cancer
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Jan 1, 2020
• Actual Study Completion Date: Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: chemotherapy group patients receive 4 cycles of Xelox	Drug: XELOX; Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks

Outcome Measures

Primary Outcome Measures

1. tumor volume [At the end of Cycle 2 (each cycle is 3 weeks)]

   tumor volume measured by MRI

2. tumor area in endoscopy [At the end of Cycle 2 (each cycle is 3 weeks)]

   tumor area measured in endoscopy

3. tumor volume [At the end of Cycle 4 (each cycle is 3 weeks)]

   tumor volume measured by MRI

4. tumor area in endoscopy [At the end of Cycle 4 (each cycle is 3 weeks)]

   tumor area measured in endoscopy

Secondary Outcome Measures

1. blood DNA test [At the end of Cycle 2 (each cycle is 3 weeks)]

   blood DNA test

2. blood DNA test [At the end of Cycle 4 (each cycle is 3 weeks)]

   blood DNA test

3. tumor thickness in TRUS [At the end of Cycle 4 (each cycle is 3 weeks)]

   tumor thickness in TRUS

4. tumor thickness in TRUS [At the end of Cycle 2 (each cycle is 3 weeks)]

   tumor thickness in TRUS

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. .endoscopy and biopsy verified rectal cancer within 12cm from anal verge;

2. .primary MRI, TRUS, abdomino-chest CT diagnosed early or intermediate or bad Stage II/III rectal cancer;

3. .age from 20-75;

4. .with informed consent;

Exclusion Criteria:

1. .refuse the further treatment after recruiting;

2. .diagnosis of peritoneal metastasis in the surgery;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guoxue Road 37#,West China Hospital	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• West China Hospital

Investigators

• Study Chair: Ziqiang Wang, MD, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• NCCN guideline

Publications

• 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.

• Responsible Party: Ziqiang Wang,MD, professor, West China Hospital
• ClinicalTrials.gov Identifier: NCT03666442
• Other Study ID Numbers: RC-CT-2018
• First Posted: Sep 11, 2018
• Last Update Posted: Apr 29, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ziqiang Wang,MD, professor, West China Hospital: rectal cancer；; neoadjuvant Chemotherapy
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Apr 29, 2022