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

NCT04664504 | Unknown Phase 2

• 1 other identifier: 3332019055
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rectal Cancer

Keywords

Rectal Cancer; Neoadjuvant Chemoradiotherapy; Recurrence Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 3y OS

  3 years

• 3yDMFS

  3 years

• 3yLRRFS

  3 years

Study Arms (3)

Group CRT

ACTIVE COMPARATOR

concurrent chemoradiotherapy → TME → adjuvant chemotherapy (control group)

Combination Product: Concurrent Chemoradiotherapy Radiotherapy; Drug: Adjuvant chemotherapy; Procedure: TME

Group SCRT

EXPERIMENTAL

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

Radiation: Short-course Radiotherapy; Drug: Consolidation chemotherapy; Procedure: TME

Group es-SCRT

EXPERIMENTAL

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

Radiation: Local dose increase of Short-course Radiotherapy; Drug: Consolidation chemotherapy; Procedure: TME

Interventions

Concurrent Chemoradiotherapy Radiotherapy COMBINATION_PRODUCT

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

Also known as: CRT

Group CRT

Short-course Radiotherapy RADIATION

25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.

Also known as: SCRT

Group SCRT

Local dose increase of Short-course Radiotherapy RADIATION

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.

Also known as: es-SCRT

Group es-SCRT

Consolidation chemotherapy DRUG

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.

Also known as: XEOLX*4 courses

Group SCRT; Group es-SCRT

Adjuvant chemotherapy DRUG

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

Also known as: XEOLX*6 courses

Group CRT

TME PROCEDURE

Total mesorectal excision

Group CRT; Group SCRT; Group es-SCRT

Eligibility Criteria

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

You may qualify if:

• 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
• \) 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jing Jin, M.D.: lead

Study Sites (1)

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

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Consolidation Chemotherapy; Chemotherapy, Adjuvant

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Combined Modality Therapy

Study Officials

• Yuan Tang, M.D.

  Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY DIRECTOR

Central Study Contacts

Yuan Tang, M.D.

CONTACT

+8615011304945; tangyuan82@162.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: UNKNOWN
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor, Radiotherapy Department

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: June 8, 2021

Record last verified: 2021-06

Locations

CN (1)