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Report for Clinical Trial NCT00957411

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Phase II Randomized Assessing Pelvic Irradiation Combined With Cisplatin Alone or Cisplatin Plus Cetuximab in Patients With Carcinoma of the Cervix Stage IB2, II and III

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy given together with cisplatin is more effective with or without cetuximab in treating patients with cervical cancer. PURPOSE: This randomized phase II trial is studying giving radiation therapy together with cisplatin to see how well it works compared with radiation therapy and cisplatin given together with cetuximab in treating patients with stage IB, stage II, or stage IIIB cervical cancer.

NCT00957411 Cervical Cancer
MeSH:Uterine Cervical Neoplasms
HPO:Cervical polyp Cervix cancer

2 Interventions

Name: cetuximab

Description: Given IV
Type: Biological
Group Labels: 1

Arm II

Name: cisplatin

Description: Given IV
Type: Drug
Group Labels: 2

Arm I Arm II

Primary Outcomes

Measure: Recurrence-free survival at 2 years

Secondary Outcomes

Measure: Response as assessed by MRI after radiochemotherapy and before surgery according to RECIST criteria

Measure: Toxicity according to NCI CTCAE v3.0

Purpose: Treatment

Allocation: Randomized

Parallel Assignment

There is one SNP


1 L858R

- Study the correlation between treatment response and analysis of EGFR mutations (exons 18-21 of the tyrosine kinase domain including the two hot spots L858R and E746-A750). --- L858R ---

HPO Nodes

Protein Mutations 0