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

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ClinicalTrials.gov Identifier: NCT04664504
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences

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

Condition or disease Intervention/treatment Phase
Rectal Cancer Combination Product: Concurrent Chemoradiotherapy Radiotherapy Radiation: Short-course Radiotherapy Radiation: Local dose increase of Short-course Radiotherapy Drug: Consolidation chemotherapy Drug: Adjuvant chemotherapy Procedure: TME Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Phase II Study of Individualized Neoadjuvant Chemoradiotherapy for Rectal Cancer Based on Recurrence Risk
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2025
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group CRT
concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)
 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.
Other Name: CRT

Drug: 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
Other Name: XEOLX*6 courses

Procedure: TME
Total mesorectal excision
Experimental: Group SCRT
Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
 Radiation: Short-course Radiotherapy
25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
Other Name: SCRT

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.
Other Name: XEOLX*4 courses

Procedure: TME
Total mesorectal excision
Experimental: Group es-SCRT
Local dose increase of Short-course radiotherapy→ consolidation chemotherapy → TME (experimental group)
 Radiation: 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.
Other Name: es-SCRT

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.
Other Name: XEOLX*4 courses

Procedure: TME
Total mesorectal excision


Outcome Measures
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Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 1 year ]
    R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after individualized chemoradiotherapy


Secondary Outcome Measures :
  1. 3y OS [ Time Frame: 3 years ]
    3-year overall survival

  2. 3yDMFS [ Time Frame: 3 years ]
    3-year distant metastatic free survival

  3. 3yLRRFS [ Time Frame: 3 years ]
    3-year locoregional recurrence-free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664504


Contacts
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Contact: Yuan Tang, M.D. +8615011304945 tangyuan82@162.com

Locations
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China
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Recruiting
Beijing, China, 100021
Contact: Yuan Tang, MD    0086-15011304945    tangyuan82@162.com   
Sponsors and Collaborators
Jing Jin, M.D.
Investigators
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Study Director: Yuan Tang, M.D. Chinese Academy of Medical Sciences and Peking Union Medical College
More Information
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Responsible Party: Jing Jin, M.D., Clinical Professor, Radiotherapy Department, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04664504    
Other Study ID Numbers: 3332019055
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jing Jin, M.D., Chinese Academy of Medical Sciences:
Rectal Cancer
Neoadjuvant Chemoradiotherapy
Recurrence Risk
Additional relevant MeSH terms:
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Rectal Neoplasms
Recurrence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes