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Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04923620
Recruitment Status : Recruiting
First Posted : June 11, 2021
Last Update Posted : April 18, 2022
Information provided by (Responsible Party):
Cai Zhenghao, Shanghai Minimally Invasive Surgery Center

Brief Summary:
Prospectively Investigate the effectiveness and safety of neoadjuvant cetuximab + chemotherapy (mFOLFOX6) combined with short-course radiotherapy (25Gy/5Fx) for RAS wild-type locally advanced rectal cancer

Condition or disease Intervention/treatment
Neoadjuvant Treatment Rectal Cancer Cetuximab Radiotherapy Drug: cetuximab+mFOLFOX6 Radiation: short-course radiotherapy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 51 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Efficacy and Safety of Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy for RAS Wild-type Locally Advanced Rectal Cancer
Actual Study Start Date : October 20, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab

Intervention Details:
  • Drug: cetuximab+mFOLFOX6
    cetuximab 500mg/m2 d1 Oxaliplatin 85mg/m2 d1 Calcium Folinate 400mg/m2 d1 5-fluorouridine 400mg/m2 d1 5-fluorouridine 2400mg/m2 46h q2w, 6 cycles
  • Radiation: short-course radiotherapy
    25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6

Primary Outcome Measures :
  1. Pathological response rate [ Time Frame: two weeks after surgery ]
    Tumor Regression Grade 0-1

Secondary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: two weeks after surgery ]
    Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)

  2. 2-year local control rate [ Time Frame: 2 years after enrollment ]
    Refers to the probability of not finding local recurrence of tumor within 2 years,including anastomotic recurrence confirmed by pathological biopsy, pelvic tumor recurrence confirmed by imaging examination, or suspected pelvic recurrence with CEA exceeding the normal upper limit.

  3. 2-year metastasis-free rate 2-year distant metastasis free rate [ Time Frame: 2 years after enrollment ]
    Refers to the probability of no distant metastasis within 2 years

  4. Overall survival [ Time Frame: 2 years after enrollment ]
    Refers to the time from the start of treatment to death due to any cause.

  5. disease-free survival [ Time Frame: 2 years after enrollment ]
    Refers to the time from the start of treatment to recurrence.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18 to 75 years with locally advanced rectal cancer, regardless of gender, ethnicity and regional distribution, were involved in this study. Patients were required to be in good health and have sufficient organ function and bone marrow function.

Inclusion Criteria:

  1. A biopsy proven histological diagnosis of rectal adenocarcinoma;
  2. An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;
  3. No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
  4. MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
  5. Age between 18-75 years;
  6. ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
  7. Has sufficient organ function:

    • Hemopoietic function: hemoglobin ≥ 90 g / L, platelet ≥ 80 g / L × 109 / L, neutrophils ≥ 1.5 × 109/L
    • Liver function: ALT and AST < 2.5 × ULN;
    • Renal function: serum creatinine < 1.5 ULN;
  8. Willing to participate and informed consent signed;

Exclusion Criteria:

  1. Patients with mutations in any of KRAS, NRAS, or BRAF, microsatellite instablility-High;
  2. Patients having undergone chemotherapy, radiotherapy or surgery for colorectal cancer;
  3. Patients with other uncontrolled malignant tumors (except early-stage basal cell carcinoma or cervical carcinoma in situ) ;
  4. Female patients who are pregnant or breastfeeding;
  5. Patients with severe heart, liver, or kidney, or neurological or psychiatric disease;
  6. Patients with active infection;
  7. Poor overall health status, ECOG ≥ 2;
  8. Patients with concomitant diseases that seriously endanger the safety of patients or affect the completion of the study in the judgment of the investigator;
  9. Known hypersensitivity reactions to any investigational drugs;

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): NCT04923620

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Contact: Zhenghao Cai, MD +862164458887 c3z2h1@alumni.sjtu.edu.cn

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China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200020
Contact: Zhenghao Cai    +862164458887    c3z2h1@alumni.sjtu.edu.cn   
Sponsors and Collaborators
Shanghai Minimally Invasive Surgery Center
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Responsible Party: Cai Zhenghao, MD, Shanghai Minimally Invasive Surgery Center
ClinicalTrials.gov Identifier: NCT04923620    
Other Study ID Numbers: MISC-Cet-FOLFOX-SCRT
First Posted: June 11, 2021    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents