Preoperative Panitumumab and Radiotherapy in Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma.

Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.

Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.

Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.

Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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panitumumab

Group Type EXPERIMENTAL

panitumumab

Intervention Type DRUG

intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days

Interventions

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panitumumab

intravenous infusion of panitumumab, 6 mg per kg body weight, once every 14 days for a total of 42 days

Intervention Type DRUG

Other Intervention Names

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Vectibix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No