Clinical trial · Interventional
Preoperative Panitumumab and Radiotherapy in Rectal Cancer
Phase II Study of Preoperative Panitumumab and External Beam Radiotherapy in Patients With Locally Advanced Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The intermediate analyses did not allowed to continue the clinical study.
Summary
Brief summary (as posted)
The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy. The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.
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 | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| panitumumab | Drug | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- panitumumab
- interventionNames
- Drug: panitumumab
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- 11 weeks
Secondary outcomes (1)
- measure
- Safety, pathologic R0 resection, negative Circumferential Resection Margin, pathologic downstaging, tumor regression grade, quality of mesorectal excision, rate of sphincter-preservation, Disease-Free Survival, local control rate, translational research
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ECOG Performance Status 0-1 * Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0 * Wild-type KRAS * No prior pelvic irradiation * Normal bone marrow, hepatic, renal, cardiac functions * No secondary malignancy * No other active, uncontrolled disease * Signed informed consent Exclusion Criteria: * KRAS mutation * Established or suspected metastasis * Prior pelvic irradiation * Previous exposure to EGFR-targeting therapies * Patients under any other investigational agent(s) * Concurrent systemic immune therapy, chemotherapy, hormone therapy * Drug and/or alcohol abuse * Grade 3 to 4 allergic reaction to any of the components of the treatment * History or presence of interstitial lung disease * Active, uncontrolled cardiovascular disease
References
Publications (0)
Data not yet available