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Pelvic Radiation Therapy After Surgery in Treating Patients With Early-Stage Endometrial Cancer

2014-07-24 14:00:39 | BioPortfolio

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. It is not yet known whether intensity-modulated radiation therapy is more effective than external-beam radiation therapy in treating patients with early-stage endometrial cancer.

PURPOSE: This randomized phase II trial is comparing two types of pelvic radiation therapy given after surgery in treating patients with early-stage endometrial cancer.

Description

OBJECTIVES:

Primary

- To compare the incidence of grade 2 or higher acute genitourinary and gastrointestinal toxicity in patients with early-stage endometrial cancer treated with adjuvant pelvic radiotherapy comprising either intensity-modulated radiotherapy or 2-dimensional virtual-simulation planning.

Secondary

- To compare the incidence of late genitourinary and gastrointestinal toxicity in these patients.

- To determine the feasibility of implementing pelvic nodal irradiation in gynecological cancer.

- To establish an image-guided pathway for gynecological cancer radiotherapy incorporating set-up errors and optimal margins for set-up uncertainty and investigation of effects of bladder filling and rectal preparation protocols on the planning target volume.

- To determine the rate of loco-regional control in these patients.

- To evaluate the quality of life of these patients.

- To determine the rate of disease-free survival of these patients

- To determine the overall survival of these patients.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

- Arm I (control): Patients undergo external-beam pelvic radiotherapy delivered using a 2-dimensional virtual-simulation planned technique followed by vaginal vault brachytherapy.

- Arm II (experimental): Patients undergo external-beam pelvic radiotherapy delivered using intensity-modulated radiotherapy followed by vaginal vault brachytherapy.

Patients complete quality of life questionnaires (EORTC QLQ C30 and EORTC QLQ Cervical Cancer Specific Module CX 24) at baseline, at the end of treatment, at 6 and 12 months, once a year for up to year 5, and then twice a year thereafter for up to year 10.

After completion of study treatment, patients are followed every 3 months for year 1, every 6 month for 1 year, and then once a year for up to 10 years.

Study Design

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

Conditions

Endometrial Cancer

Intervention

questionnaire administration, adjuvant therapy, assessment of therapy complications, quality-of-life assessment, brachytherapy, external beam radiation therapy, intensity-modulated radiation therapy, radiation therapy treatment planning/simulation

Location

Saint Luke's Hospital
Dublin
Ireland
6

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:00:39-0400

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Medical and Biotech [MESH] Definitions

Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.

Radiotherapy given to augment some other form of treatment such as surgery or chemotherapy. Adjuvant radiotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.

The assessment, treatment, and management of soft tissue injury or dysfunction. Therapy is designed to reduce tension and irritation in affected tissues and may include MASSAGE; muscle stretching, or direct pressure on muscles, connective tissue, and TRIGGER POINTS.

The therapy of the same disease in a patient, with the same agent or procedure repeated after initial treatment, or with an additional or alternate measure or follow-up. It does not include therapy which requires more than one administration of a therapeutic agent or regimen. Retreatment is often used with reference to a different modality when the original one was inadequate, harmful, or unsuccessful.

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