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NCT Number: NCT05338866

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

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Magnetic resonance guided radiotherapy

Radiation

Radical radiotherapy boosting for low rectal cancer through magnetic resonance guided radiotherapy linear accelerator.

Chemotherapy

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 3-year stoma free survival rate

    Time frame: 3-year after enrollment

    Percentage of patients survive with no enterostomy after 3 years from enrollment.

  2. 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. 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

  4. 3-year distant metastasis rate

    Time frame: 3-year after enrollment

    The percentage of patients with distant metastasis.

  5. 3-year overall survival rate

    Time frame: 3-year after enrollment

    The percentage of patients survive 3 years after enrollment

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2030
Study completion
2033
First posted
Apr 21, 2022
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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