search
Back to results

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

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Concurrent Chemoradiotherapy Radiotherapy
Short-course Radiotherapy
Local dose increase of Short-course Radiotherapy
Consolidation chemotherapy
Adjuvant chemotherapy
TME
Sponsored by
Jing Jin, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, Neoadjuvant Chemoradiotherapy, Recurrence Risk

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group CRT

Group SCRT

Group es-SCRT

Arm Description

concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)

Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)

Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)

Outcomes

Primary Outcome Measures

R0 resection rate
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy

Secondary Outcome Measures

3y OS
3-year overall survival
3yDMFS
3-year distant metastatic free survival
3yLRRFS
3-year locoregional recurrence-free survival

Full Information

First Posted
December 6, 2020
Last Updated
June 6, 2021
Sponsor
Jing Jin, M.D.
search

1. Study Identification

Unique Protocol Identification Number
NCT04664504
Brief Title
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Official Title
A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Jin, M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer, Neoadjuvant Chemoradiotherapy, Recurrence Risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group CRT
Arm Type
Active Comparator
Arm Description
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
Arm Title
Group SCRT
Arm Type
Experimental
Arm Description
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Arm Title
Group es-SCRT
Arm Type
Experimental
Arm Description
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
Intervention Type
Combination Product
Intervention Name(s)
Concurrent Chemoradiotherapy Radiotherapy
Other Intervention Name(s)
CRT
Intervention Description
50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
Intervention Type
Radiation
Intervention Name(s)
Short-course Radiotherapy
Other Intervention Name(s)
SCRT
Intervention Description
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Intervention Type
Radiation
Intervention Name(s)
Local dose increase of Short-course Radiotherapy
Other Intervention Name(s)
es-SCRT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Consolidation chemotherapy
Other Intervention Name(s)
XEOLX*4 courses
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Adjuvant chemotherapy
Other Intervention Name(s)
XEOLX*6 courses
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
TME
Intervention Description
Total mesorectal excision
Primary Outcome Measure Information:
Title
R0 resection rate
Description
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy
Time Frame
1 year
Secondary Outcome Measure Information:
Title
3y OS
Description
3-year overall survival
Time Frame
3 years
Title
3yDMFS
Description
3-year distant metastatic free survival
Time Frame
3 years
Title
3yLRRFS
Description
3-year locoregional recurrence-free survival
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Rectal adenocarcinoma confirmed by histopathology MRI staging was stage II / III (cT3-T4N0 or cT2-4N+) 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: History of other malignant tumors; They were allergic to 5-FU, platinum, etc; 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; After the previous renal history, proteinuria or clinical renal function were found to be abnormal; History of gastrointestinal fistula, perforation or severe ulcer; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Tang, M.D.
Phone
+8615011304945
Email
tangyuan82@162.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan Tang, M.D.
Organizational Affiliation
Chinese Academy of Medical Sciences and Peking Union Medical College
Official's Role
Study Director
Facility Information:
Facility Name
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan Tang, MD
Phone
0086-15011304945
Email
tangyuan82@162.com

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs