Clinical trial NCT01101451: Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
Official title: Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated With Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)
Conditions: Cervical Adenocarcinoma
Cervical Adenosquamous Carcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Stage I Cervical Cancer AJCC v6 and v7
Stage IA Cervical Cancer AJCC v6 and v7
Stage IB Cervical Cancer AJCC v6 and v7
Stage IIA Cervical Cancer AJCC v7
Summary: This randomized phase III trial studies radiation therapy with chemotherapy to see how well they work compared to radiation therapy alone in treating patients with stage I-IIA cervical cancer who previously underwent surgery. 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, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving radiation therapy together with chemotherapy is more effective than radiation therapy alone in treating patients with cervical cancer.
Interventions:
description: Given IV
name: Cisplatin
other_name: Abiplatin
Blastolem
Briplatin
CDDP
Cis-diammine-dichloroplatinum
Cis-diamminedichloridoplatinum
Cis-diamminedichloro Platinum (II)
Cis-diamminedichloroplatinum
Cis-dichloroammine Platinum (II)
Cis-platinous Diamine Dichloride
Cis-platinum
Cis-platinum II
Cis-platinum II Diamine Dichloride
Cismaplat
Cisplatina
Cisplatinum
Cisplatyl
Citoplatino
Citosin
Cysplatyna
DDP
Lederplatin
Metaplatin
Neoplatin
Peyrone''s Chloride
Peyrone''s Salt
Placis
Plastistil
Platamine
Platiblastin
Platiblastin-S
Platinex
Platinol
Platinol- AQ
Platinol-AQ
Platinol-AQ VHA Plus
Platinoxan
Platinum
Platinum Diamminodichloride
Platiran
Platistin
Platosin
type: Drug
description: Undergo radiotherapy
name: External Beam Radiation Therapy
other_name: Definitive Radiation Therapy
EBRT
External Beam RT
External Beam Radiation
External Beam Radiotherapy
External Radiation Therapy
Radiation, External Beam
external radiation
external-beam radiation
type: Radiation
description: Undergo radiotherapy
name: Intensity-Modulated Radiation Therapy
other_name: IMRT
Intensity Modulated RT
Intensity-Modulated Radiotherapy
Radiation, Intensity-Modulated Radiotherapy
type: Radiation
description: Correlative studies
name: Laboratory Biomarker Analysis
type: Other
description: Ancillary studies
name: Quality-of-Life Assessment
other_name: Quality of Life Assessment
type: Other
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: Patients undergo pelvic EBRT or IMRT once daily, 5 days a week, for 5.5 weeks.
design_group_title: Arm I (EBRT, IMRT)
design_group_type: Active Comparator
design_group_description: Patients receive cisplatin IV over 1-2 hours on day 1 and undergo radiotherapy as in Arm I. Treatment with cisplatin repeats every 7 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm II (cisplatin, EBRT, IMRT)
design_group_type: Experimental
Sponsor: The Gynecologic Oncology Group
Collaborators: National Cancer Institute
Drug name mappings:
name: 顺铂
lang: CN
name: Cisplatin
lang: EN
name: シスプラチン
lang: JP