Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator

November 21, 2023 updated by: Yuan-hong Gao, Sun Yat-sen University

Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using Magnetic Resonance Guided Radiotherapy Linear Accelerator：A Prospective Phase 2 Trial

The incidence rate of colorectal cancer is third in male tumors and second in female tumors. The newly diagnosed incidence of colorectal cancer is no less than 100 thousand in China, which poses a great threat to people's health and a heavy burden of public health. Preoperative neoadjuvant radiotherapy and chemotherapy combined with radical surgery is recommended for locally advanced rectal cancer. Low rectal cancer accounts for about one third of all rectal cancer cases. Due to the particularity of its location，surgical complications and postoperative patients need permanent colostomy (artificial anus) to solve the defecation problems, which has a serious impact on the patients' work and life. How to improve the quality of life of patients without reducing the survival rate has become an important topic in the treatment of low rectal cancer. Previous studies have shown that the prognosis of patients with pathological complete remission (pCR) after neoadjuvant chemoradiotherapy for rectal cancer is optimistic. The clinical efficacy of "observation and waiting" is good. The results of small sample exploratory clinical studies of radical radiotherapy and chemotherapy for low rectal cancer are satisfactory, and MR-linear accelerator can be used for precision radiotherapy for colorectal cancer.

This study is aimed to explore the efficacy and safety of radical radiotherapy boost for low rectal cancer by using magnetic resonance guided radiotherapy system, and further evaluate the impact of boost on the quality of life of patients.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

It is a prospective phase II, non-randomized controlled designed clinical study. For the optimal design, 58 cases of low rectal adenocarcinoma without metastasis were divided into queue 1 and queue 2 according to the start time of boost. MR-linear accelerator was used for dose boost of the local tumor region to make it reaching the radical radiotherapy dose. At the same time, fluorouracil based chemotherapy was given according to stages.

The primary endpoint was 3-year progression free survival rate. The secondary end points were 3-year stoma free survival rate, 3-year local regeneration rate, 3-year disease-free survival rate, 3-year distant metastasis rate, 3-year overall survival rate, short term and long-term toxic and side effects, and patients' quality of life scale 1-3 years after treatment.

Study Type

Observational

Enrollment (Estimated)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with lower rectal cancer who refuse surgery for various reasons or are not suitable for surgery due to systemic diseases.

Description

Inclusion Criteria:

  1. Histologically confirmed as rectal adenocarcinoma.
  2. MRI and / or electronic colonoscopy confirmed that the lower edge of the tumor was ≤ 5cm from the anal edge.
  3. The AJCC clinical stage was cT1-4NxM0, with or without MRF positive and EMVI positive.
  4. MSI gene detection or MMR protein immunohistochemical detection was MSS / PMMR.
  5. No obvious signs of intestinal obstruction or intestinal obstruction has been relieved after proximal colostomy.
  6. Age: 18 ~ 80 years old.
  7. ECOG score: 0-1.
  8. Expected life: more than 3 years.
  9. Hematology: WBC > 3 × 109/L; PLT>80 × 109/L; Hb>90g/L.
  10. Liver function: ALT and AST were less than 2 times of normal value; Bilirubin is less than 1.5 times of normal value.
  11. Renal function: creatinine is less than 1.5 times of normal value or creatinine clearance rate (CCR) ≥ 60ml / min.
  12. Patient who has not received tumor resection, radiotherapy, chemotherapy, immunotherapy or other anti-tumor treatment.

Exclusion Criteria:

  1. There are any conditions that make MRI impossible.
  2. There are serious medical complications.
  3. Uncontrolled infectious diseases, autoimmune diseases and mental diseases.
  4. Any unstable condition or situation that may endanger patient safety and compliance.
  5. Pregnant or lactating women who are fertile and do not take adequate contraceptive measures.
  6. Refuse to sign informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1. Cohort 2

A total of 6 courses of oxaliplatin plus capecitabine chemotherapy and 2 courses of capecitabine single drug chemotherapy were performed. Concurrent chemoradiotherapy starts at the second cycle.

Cohort 1: For patients with low rectal cancer who refused surgery before the initial diagnosis and treatment, the first stage of radiotherapy used conventional linear accelerated radiotherapy, with doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. Subsequently, the second stage of radiotherapy boost was continued with MR linear accelerator, and the dose was GTV 16~20Gy/8~10f for 2 weeks.

Cohort 2: For locally advanced low rectal cancer patients who did not achieve clinical complete remission 6-8 weeks after neoadjuvant radiochemotherapy and refused surgery, radiotherapy was given in the first stage at the doses of GTV 50Gy/25f and CTV 45Gy/25f for 5-6 weeks. In the second stage, MR linear accelerator was used for radiotherapy boosting, and the dose was GTV 30Gy/15f for 3 weeks.
Radiation: Magnetic resonance guided radiotherapy
Radical radiotherapy boosting for low rectal cancer through magnetic resonance guided radiotherapy linear accelerator.
Drug: Chemotherapy

For patients with AJCC stage II and III and age < 72 years old, Capox ×6→capecitabine×2.

Detailed usage: Oxaliplatin 130mg/m2 (reduced to 100mg/m2 during concurrent chemoradiotherapy), intravenous administration, d1. Capecitabine 1000mg / m2, twice a day, d1-14. Repeated every 3 weeks.

For patients aged ≥ 72 years, or the competent physician judges that the patients cannot tolerate dual drug combined chemotherapy, capecitabine ×8 courses.

For patients with AJCC stage I, capecitabine ×4 courses.

Other Names:
  • Capox, Capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year progression free survival rate
Time Frame: 3-year after enrollment
Percentage of survive patients with no disease progression or death after 3 years from enrollment.
3-year after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year stoma free survival rate
Time Frame: 3-year after enrollment
Percentage of patients survive with no enterostomy after 3 years from enrollment.
3-year after enrollment
3-year local regeneration rate
Time Frame: 3-year after enrollment
Percentage of patients with no local tumor regeneration after 3 years from enrollment.
3-year after enrollment
3-year disease-free survival rate
Time Frame: 3-year after enrollment
The percentage of patients survive with no disease after 3 years from enrollment
3-year after enrollment
3-year distant metastasis rate
Time Frame: 3-year after enrollment
The percentage of patients with distant metastasis.
3-year after enrollment
3-year overall survival rate
Time Frame: 3-year after enrollment
The percentage of patients survive 3 years after enrollment
3-year after enrollment
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: During treatment. 3-month, 6-month, 1-year, 3-year after treatment.
Acute and chronic toxic and side effects
During treatment. 3-month, 6-month, 1-year, 3-year after treatment.
Patients' quality of life scale
Time Frame: Before and during treatment. 3-month, 6-month, 1-year, 3-year after enrollment.
Patients' quality of life scale
Before and during treatment. 3-month, 6-month, 1-year, 3-year after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Yuanhong Gao, PhD, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2033

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 14, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-FXY-489

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study data can be shared after publication of the study results, upon request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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