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Neoadjuvant Cetuximab + Chemotherapy Combined With Short-course Radiotherapy

China51 participantsStarted 2021-10-20

Plain-language 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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. Willing to participate and informed consent signed；

Exclusion criteria

. 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) ;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathological response rate

Timeframe: two weeks after surgery

Trial details

NCT IDNCT04923620

SponsorShanghai Minimally Invasive Surgery Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-08-31

Contact for this trial

Zhenghao Cai, MD

+862164458887 c3z2h1@alumni.sjtu.edu.cn

View on ClinicalTrials.gov More Neoadjuvant Treatment trials