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Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage IB, Stage II, or Stage IIIB Cervical Cancer

2014-08-27 03:20:04 | BioPortfolio

Summary

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.

Description

OBJECTIVES:

Primary

- Evaluate the efficacy of treatment with cetuximab and a standard radiochemotherapy regimen (pelvic radiotherapy and cisplatin) in patients with stage IB2, II, and IIIB cervical cancer by evaluating the number of patients without recurrence at 2 years.

Secondary

- Analyze the tumor response by MRI after external radiotherapy.

- Assess the tolerance of cetuximab and standard radiochemotherapy in patients not previously treated and in generally good condition.

- 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).

- Study the correlation between treatment response and evaluation of number of copies of the EGFR gene.

- Study the correlation between treatment response and analysis of mutations of codons 12 and 13 of KRAS2 by direct sequencing.

- Study the correlation between treatment response and research of DNA sequences of human papillomavirus.

- Study the correlation between treatment response and overexpression of EGFR and COX2 (centralized) by IHC.

- Study the correlation between treatment response and characterization of a genomic signature (genome, transcriptome, and Affymetrix chips from samples frozen in liquid nitrogen).

- Collect tumor samples for molecular analysis.

OUTLINE: This is a multicenter study. Patients are stratified according to planned surgery (yes vs no) and are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cisplatin IV over 1 hour once weekly during weeks 1-6. Patients also undergo pelvic radiotherapy 5 days a week during weeks 2-5 or 2-6.

- Arm II: Patients receive cisplatin and undergo radiotherapy as in arm I. Patients also receive cetuximab IV over 1 hour once weekly during weeks 1-6.

After 6-8 weeks of study treatment, patients continue treatment as recommended by their center (i.e., utero-vaginal brachytherapy, additional radiotherapy, or surgery).

Tumor tissue and blood samples are collected for further analysis.

After completion of study treatment, patients are followed at 3-4 weeks and then every 4 months for 2 years.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cervical Cancer

Intervention

cetuximab, cisplatin

Location

Institut Curie Hopital
Paris
France
75248

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:04-0400

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Medical and Biotech [MESH] Definitions

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

Morphological abnormalities of the cervical EPITHELIUM, usually revealed in PAP SMEAR, which do not meet the criteria for squamous CERVICAL INTRAEPITHELIAL NEOPLASIA or SQUAMOUS CELL CARCINOMAS of the CERVIX . It may be a sign of infection with certain types of human papillomavirus (HPV).or sign of a benign (not cancer) growth, such as a cyst or polyp or, in menopausal women, of low hormone levels. More testing, such as HPV test, may be needed.

A network of nerve fibers originating in the upper four cervical spinal cord segments. The cervical plexus distributes cutaneous nerves to parts of the neck, shoulders, and back of the head, and motor fibers to muscles of the cervical spinal column, infrahyoid muscles, and the diaphragm.

A parameter usually used in PRENATAL ULTRASONOGRAPHY to measure the length of the uterine neck (CERVIX UTERI). Cervical length or its shortening is used to identify and prevent early cervical opening and PRETERM BIRTH.

Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)

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