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Clinical Trials/EUCTR2008-006012-38-HU
EUCTR2008-006012-38-HU
Active, not recruiting
Not Applicable

eoadjuvant radiotherapy and capecitabine with or without panitumumab in patients with advanced, K-ras unmutated rectal cancer. A randomized multicenter phase II trial.

SAKK (Swiss Group for Clinical Cancer Research)0 sites67 target enrollmentOctober 27, 2010
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DrugsVECTIBIX

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
SAKK (Swiss Group for Clinical Cancer Research)
Enrollment
67
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 27, 2010
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
SAKK (Swiss Group for Clinical Cancer Research)

Eligibility Criteria

Inclusion Criteria

  • •\- Histologically confirmed advanced adenocarcinoma of the rectum with or without nodal involvement requiring surgery, stage mrT 3/4 and/or mrN 1/2 cM0\.
  • •\- Tumors with the wild type K\-ras gene
  • •\- Patient is considered operable
  • •\- Age \>\= 18 years
  • •\- Adequate hematological values
  • •\- Adequate renal and hepatic function
  • •\- Women are not breastfeeding, are using contraception if sexually active, are not pregnant
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •\- Previous malignancy within 5 years (with exception of adequately treated cervical carcinoma or localized non\-melanoma skin cancer)
  • •\- Distant metastasis
  • •\- Concurrent treatment with other experimental drugs or other anti\-cancer therapy
  • •\- Any prior treatment for rectal cancer
  • •\- Prior anti\-EGFR antibody therapy or treatment with small molecule EGFR inhibitors
  • •\- Pre\-existing condition which would preclude radiotherapy
  • •\- Organ allografts
  • •\- Any concomitant drugs contraindicated for use with the trial drugs

Outcomes

Primary Outcomes

Not specified

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