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Clinical Trials/EUCTR2008-006312-38-HU
EUCTR2008-006312-38-HU
Active, not recruiting
Not Applicable

eoadjuvant radiotherapy combined with capecitabine and sorafenib in patients with advanced, K-ras mutated rectal cancer. A randomized multicenter phase I/II trial.

SAKK (Swiss Group for Clinical Cancer Research)0 sites47 target enrollmentDecember 6, 2010
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ConditionsAdvanced K-ras mutated rectal cancer.
DrugsNEXAVARXeloda

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Advanced K-ras mutated rectal cancer.
Sponsor
SAKK (Swiss Group for Clinical Cancer Research)
Enrollment
47
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 6, 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 K\-ras gene mutation
  • •\- Patient is considered operable
  • •\- Age \>\= 18 years
  • •\- Adequate hematological values
  • •\- Adequate renal and hepatic function
  • •\- PT\-INR \<\= 1\.5 or PTT \<\= 1\.5 x ULN
  • •\- Women are not breastfeeding, are using contraception if sexually active, are not pregnant
  • •\- Men agree not to father a child
  • •Are the trial subjects under 18? no

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
  • •\- Patients with evidence or history of bleeding diathesis
  • •\- Uncontrolled hypertension
  • •\- Organ allografts
  • •\- Any concomitant drugs contraindicated for use with the trial drugs

Outcomes

Primary Outcomes

Not specified

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