Clinical trial · Interventional
Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis
A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.
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 |
|---|---|---|---|
| Rectal Cancer, Metastatic | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- chemotherapy with radiotherapy
- description
- Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
- interventionNames
- Drug: chemotherapy
- Radiation: radiotherapy
Primary outcomes (1)
- measure
- complete resection (R0) rate for rectal and liver lesions
- timeFrame
- after surgical resection, an average of 24 weeks
Secondary outcomes (1)
- measure
- Response rate (RECIST V1.1)
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis * over 19 years * Eastern Cooperative Oncology Group 0-1 * Proper organ function * more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1) * Who should sign on the Informed consent form before participate the trial. Exclusion Criteria: * Metastasis in other organ except liver * Chronic active hepatitis or cirrhosis * History of treatment for metastatic colorectal cancer * Subject pregnant or breast feeding * Uncontrolled disease * Have had adjuvant therapy * Uncontrolled peripheral nerve infection * Alcoholic or drug addict * Subject currently is enrolled in or ≤30 days from ending other clinical trial. * History of other type of cancer except resolved from skin cancer and cervical cancer.
References
Publications (0)
Data not yet available