Clinical trial · Interventional
Radiation Therapy, Chemotherapy, and Cetuximab Followed by Surgery, Chemotherapy, and Cetuximab in Treating Patients With Locally Advanced or Metastatic Rectal Cancer That Can Be Removed by Surgery
Phase II Multicenter Study of the Impact of the Therapeutic Sequence of Radiochemotherapy (50 Gy + Capecitabine + Oxaliplatin + Cetuximab) Followed by Total Mesorectal Excision Surgery Then Post-surgery Chemotherapy (FOLFOX 4 + Cetuximab) in Synchronous Locally Advanced or Metastatic Cancers of the Rectum With Metastases Resectable From the Start (T3-4 Nx or T2 N+ M1).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Toxicity and lack of efficacy
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, oxaliplatin, fluorouracil, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving radiation therapy together with combination chemotherapy and cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving chemotherapy and cetuximab after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II clinical trial is studying how well giving radiation therapy together with chemotherapy and cetuximab followed by surgery, chemotherapy, and cetuximab works in treating patients with locally advanced or metastatic rectal cancer that can be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation therapy |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Complete remission at ≥ 6 months by abdomino-pelvic-thoracic scan and a pelvic MRI
Secondary outcomes (13)
- measure
- Preoperative clinical response
- measure
- Progression-free survival
- measure
- Overall survival
- measure
- Early toxicity before surgery
- measure
- Early toxicity due to surgery (mortality at 30 days, postoperative complications, surgical recovery)
- measure
- Late toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the rectum
* Locally advanced (T3-4 Nx) or metastatic (T2 N+ M1) synchronous disease
* Metastases must be resectable
* Primary tumor examined by endorectal echography and MRI
* Measurable disease by thoraco-abdomino-pelvic scanner
* Disease considered susceptible to treatment with radiotherapy and chemotherapy
* No diffuse metastases considered nonresectable
* No acute occlusion not caused by colostomy
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* WBC ≥ 4,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Creatinine ≤ 130 µmol/L
* Transaminases ≤ 5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients of must use effective contraception
Exclusion criteria:
* Contraindication to therapy with capecitabine, oxaliplatin, cetuximab, and/or radiotherapy
* Impossible to perform translational analyses
* Uncontrolled severe illness
* Severe renal or hepatic insufficiency
* Cardiac insufficiency or symptomatic coronary disease
* Sensitive peripheral neuropathy
* Uncontrolled diabetes
* Other malignancy within the past 10 years except previously treated basal cell skin cancer or carcinoma in situ of the cervix
* Impossible to participate in study due to geographic, social, or psychiatric reasons
* Patients who are under supervision or incarcerated
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior anticancer chemotherapy or radiotherapy for this cancer
* No therapy with coumarin anticoagulants, phenytoin, sorivudine, brivudine, antacids, or allopurinol
* No concurrent participation in another therapeutic study or receiving another experimental drugReferences
Publications (0)
Data not yet available