Neoadjuvant TreatmentNCT04923620
Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy
An observational study of Neoadjuvant Treatment and Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Treatment, Rectal Cancer, Cetuximab
- What is being tested?
- cetuximab+mFOLFOX6 and short-course radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
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- 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；
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200020
Zhenghao Cai, +862164458887, c3z2h1@alumni.sjtu.edu.cn
About this study
Official title: Efficacy and Safety of Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy for RAS Wild-type Locally Advanced Rectal Cancer
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
- Being tested
- cetuximab+mFOLFOX6, short-course radiotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cetuximab+mFOLFOX6Drug
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 radiotherapyRadiation
25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological response rate
Tumor Regression Grade 0-1
Measured: two weeks after surgery
Secondary outcomes (5)
Pathological complete response rate
Refers to the pathological examination of primary tumors and lymph node surgical specimens without residual infiltrating tumor cells (ypT0N0, TRG 0)
Measured: two weeks after surgery
2-year local control rate
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.
Measured: 2 years after enrollment
2-year metastasis-free rate 2-year distant metastasis free rate
Refers to the probability of no distant metastasis within 2 years
Measured: 2 years after enrollment
Overall survival
Refers to the time from the start of treatment to death due to any cause.
Measured: 2 years after enrollment
disease-free survival
Refers to the time from the start of treatment to recurrence.
Measured: 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start20 Oct 2021
- Primary completion31 Aug 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 51 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cai Zhenghao, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923620
- Sponsor's protocol ID
- MISC-Cet-FOLFOX-SCRT
- Status last verified
- Feb 2024
- First submitted
- 6 Jun 2021
- Last updated
- 26 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy for RAS Wild-type Locally Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT04923620
- Acronym / sponsor ID
- MISC-Cet-FOLFOX-SCRT
- Conditions
- Neoadjuvant Treatment, Rectal Cancer, Cetuximab, Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cetuximab+mFOLFOX6cetuximab 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 | Drug | – |
| short-course radiotherapy25Gy/5Fx short-course radiotherapy between the forth and the fifth cycle of cetuximab+mFOLFOX6 | Radiation | – |
Primary outcome
Pathological response rate
Time frame: two weeks after surgery
Tumor Regression Grade 0-1
5 secondary outcomes
Pathological complete response rate
Time frame: two weeks after surgery
2-year local control rate
Time frame: 2 years after enrollment
2-year metastasis-free rate 2-year distant metastasis free rate
Time frame: 2 years after enrollment
Overall survival
Time frame: 2 years after enrollment
disease-free survival
Time frame: 2 years after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoadjuvant Treatment and Rectal Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenghao Cai, MD (+862164458887, c3z2h1@alumni.sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological response rate (time frame: two weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.