A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Rectal Cancer Clinical Trial

Official title:

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04664504
• Other study ID #: 3332019055
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2020
• Est. completion date: December 1, 2025

Study information

• Verified date: June 2021
• Source: Chinese Academy of Medical Sciences
• Contact: Yuan Tang, M.D.
• Phone: +8615011304945
• Email: tangyuan82[@]162.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk

Description:

For patients with locally advanced rectal cancer, radiotherapy and chemotherapy combined with surgery can improve the curative effect. Rectal magnetic resonance imaging (MRI) can be used to stratify the risk of locally advanced rectal cancer before treatment. In this study, we planned to use rectal MRI parameters and the possibility of patients with anal preservation to group, and to observe the R0 resection rate and disease-free survival rate of patients with stage II / III rectal cancer after individualized preoperative radiotherapy and chemotherapy combined with radical surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Rectal adenocarcinoma confirmed by histopathology

2. MRI staging was stage II / III (cT3-T4N0 or cT2-4N+)

3. The age is 18-75 years old, no gender limit

3) The distance between the lower limit of the lesion and the anal margin was less than or equal to 10 cm 4) Karnofsky score = 80 or ECOG score 0-1

Exclusion Criteria:

1. History of other malignant tumors;

2. They were allergic to 5-FU, platinum, etc;

3. The patient is in thrombolytic and anticoagulant therapy, and has bleeding quality or coagulation dysfunction; or in the past year, aneurysm, stroke, transient ischemic attack, arteriovenous malformation occurred;

4. After the previous renal history, proteinuria or clinical renal function were found to be abnormal;

5. History of gastrointestinal fistula, perforation or severe ulcer;

6. At present, there are active infection; clinical obvious heart disease; New York Heart Association (NYHA) = grade II congestive heart failure; unstable symptomatic arrhythmia or peripheral vascular disease = grade II; myocardial infarction and cerebrovascular accident occurred within 6 months before enrollment.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms
• Recurrence

Intervention

Combination Product:
• Concurrent Chemoradiotherapy Radiotherapy
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.

Radiation:
• Short-course Radiotherapy
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
• Local dose increase of Short-course Radiotherapy
25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.

Drug:
• Consolidation chemotherapy
Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course.
• Adjuvant chemotherapy
2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses*3 weeks per course

Procedure:
• TME
Total mesorectal excision

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jing Jin, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy	1 year
Secondary	3y OS	3-year overall survival	3 years
Secondary	3yDMFS	3-year distant metastatic free survival	3 years
Secondary	3yLRRFS	3-year locoregional recurrence-free survival	3 years