High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
Condition: Cancer of Cervix; Cervical Cancer; Cancer of the Cervix; Cervix Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Radiation therapy still remains mainstay of treatment for patients with carcinoma cervix in
      advanced stages. Conventional treatment with radiation therapy includes a combination of
      external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary
      brachytherapy treatment is the time-tested modality of brachytherapy with sound
      radiobiological bases. But high dose rate brachytherapy is a relatively new alternative. In
      low dose rate brachytherapy the staff receives some radiation while in the high dose rate
      brachytherapy procedure complete protection to staff can be achieved as the treatment is done
      with remote afterloading technique. The high dose rate brachytherapy is possible as Out
      Patient Department procedure. Few clinical trials have proven the feasibility and efficacy of
      high dose rate brachytherapy in carcinoma of cervix. However, there is no concrete evidence
      especially in developing countries for the change of practice to HDR brachytherapy. Hence, at
      Tata Memorial Hospital with an aim to assess the efficacy, feasibility, early and late
      complications of high dose rate brachytherapy in contrast with low dose rate brachytherapy we
      propose this study.
    

Detailed description: 
      Carcinoma cervix is the most common malignancy in Indian women and constitutes approximately
      27% of all cancers as recorded in the annual report of Hospital based cancer registry 1991.
      Carcinoma of cervix forms one of the leading causes for death and disability due to cancers
      in India.

      Nearly 80% of the patients with carcinoma cervix present in advanced stages. Despite the
      advances in conventional modalities the five-year survival is 26% and 43% for stage IIIB and
      stage IIB respectively. In developing countries the socio-economic problems, illiteracy, late
      presentation and irregular follow-up resulting in early locoregional and distant failures
      further compound the problem.

      Radiation therapy still remains the important modality of treatment for patients with
      carcinoma cervix in advanced stages. Conventional treatment with radiation therapy includes a
      combination of external beam radiation therapy and intracavitary treatment. Low dose rate
      intracavitary treatment is the time-tested modality of brachytherapy for carcinoma of cervix
      having sound radiobiological bases. But high dose rate brachytherapy is a relatively new
      method. In low dose rate brachytherapy the staff receives some radiation while in the high
      dose rate brachytherapy procedure complete protection to staff can be achieved as the
      treatment is done with remote afterloading technique. The high dose rate brachytherapy is
      possible as OPD procedure. Various clinical trials have proved the feasibility and efficacy
      of high dose rate brachytherapy for carcinoma of cervix. At Tata Memorial Hospital we
      advocate a study to assess the efficacy, feasibility, early and late complications of high
      dose rate brachytherapy in contrast with low dose rate brachytherapy.
    

Intervention name(s): HIgh Dose Rate Vs Low DOse Rate Brachytherapy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cervical Cancer; High Dose Rate (HDR) Brachytherapy; Low Dose Rate (LDR) Brachytherapy; Acute Toxicities; Late Radiation Sequelae