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Completed

NCT Number: NCT01097252

Weekly Versus Three-week Chemoradiation in Patients With Advanced Cervical Cancer

Three weekly cisplatin based chemoradiation is to be compared the compliance, toxicity, and response rates with the weekly cisplatin based chemoradiation in the treatment of locoregionally advanced cervical cancers.

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Key information

Conditions

Cervical Cancers Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Health Behavior Neoplasms Neoplasms by Site Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

30 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Korea Institute of Radiological & Medical Sciences

Seoul, 139-706, South Korea

About this study

This study is to compare the compliance, toxicity, response and survival rate between concurrent chemoradiation with weekly cisplatin 40mg/m2 and three-week cisplatin 75mg/m2 in patients with advanced cervical cancer. Patients with primary untreated invasive squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma of the cervix from stage IIB to IVA were enrolled. Patients with histologically proven locoregionally advanced cervical cancer will be randomized into two treatment arm; Arm I, concurrent chemoradiation with weekly cisplatin 40mg/m2 for six times; Arm II, concurrent chemoradiation with three-week cisplatin 75mg/m2 for three times. The compliance and toxicity during the chemoradiation is the primary endpoint. Response rate and the overall survival will be analyzed as secondary endpoints.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven cervical cancer
  • Squamous, Adenosquamous, Adeno carcinoma cell type
  • International Federation of Gynecologic Oncology (FIGO) stage IIB - IVA
  • Gynecologic Oncology Group (GOG) performance status 0 - 2

Exclusion criteria

  • Previous history of chemotherapy or radiation
  • History of other cancer
  • Hypersensitivity to platinum agents
  • Pregnancy
  • Serious medical disease

Treatment and study plan

Radiation

Radiation

radiation with cisplatin 40mg/m2, 6 cycles, every week

weekly cisplatin

Drug

weekly cisplatin 40mg/m2, 6 cycles

Other names: Cisplatin

tri-weekly cisplatin

Drug

cisplatin 75mg/m2, 3cycles, every 3 weeks

Other names: Cisplatin

Primary outcomes

  1. compliance

    Time frame: 3 month

    • Percentage of completed cycles of scheduled chemotherapy in each arm
    • Percentage of grade III and IV toxicity
    • Delayed radiation time due to toxicity

Secondary outcomes

  1. survival

    Time frame: 5 years

    • 5 year progression free survival
    • 5 year survival rate

Sponsors and collaborators

Lead sponsor

Korea Cancer Center Hospital

Other

Registry information

Official study title

Randomized Trial of Concurrent Chemoradiation With Weekly Versus Three-week Cisplatin in Patients With Advanced Cervical Cancer

Important dates

Study start
2002
Primary completion
2004
Study completion
2009
First posted
Apr 1, 2010
Registry last updated
May 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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