Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

NCT04923620 | Recruiting

• 1 other identifier: MISC-Cet-FOLFOX-SCRT
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

Neoadjuvant Treatment; Rectal Cancer; Cetuximab; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Pathological response rate

  Tumor Regression Grade 0-1

  two weeks after surgery

Secondary Outcomes (5)

• Pathological complete response rate

  two weeks after surgery

• 2-year local control rate

  2 years after enrollment

• 2-year metastasis-free rate 2-year distant metastasis free rate

  2 years after enrollment

• Overall survival

  2 years after enrollment

• disease-free survival

  2 years after enrollment

Interventions

cetuximab+mFOLFOX6 DRUG

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

short-course radiotherapy RADIATION

25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6

Eligibility Criteria

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

You may qualify if:

• A biopsy proven histological diagnosis of rectal adenocarcinoma；
• An ARMS-PCR proven KRAS, NRAS, PI3KCA and BRAF wild type;
• No intestinal obstruction, distant metastasis was excluded by CT, MRI or PET / CT;
• MRI proven T3c-T4, CRM positive, N2, extramural vascular invasion positive or lateral lymph node positive of locally advanced rectal cancer;
• Age between 18-75 years;
• ECOG (Eastern US Cooperative Oncology Group) score: 0-1;
• 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;
• Willing to participate and informed consent signed；

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Minimally Invasive Surgery Center: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200020, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

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

Central Study Contacts

Zhenghao Cai, MD

CONTACT

+862164458887; c3z2h1@alumni.sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2021
• First Posted: June 11, 2021
• Study Start: October 20, 2021
• Primary Completion: August 31, 2024
• Study Completion: June 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CN (1)