Know Cancer

forgot password

High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix

Phase 3
18 Years
65 Years
Not Enrolling
Cancer of Cervix, Cervical Cancer, Cancer of the Cervix, Cervix Cancer

Thank you

Trial Information

High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix

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, feasibilty, early and late complications of high
dose rate brachytherapy in contrast with low dose rate brachytherapy.

Inclusion Criteria:

- Histologically proven squamous carcinoma of cervix

- Performance index WHO grade 0 or 1

- Patients below 65 years of age

- Normal ECG and CVS

- Normal hematological parameters

- Normal renal and liver function tests

Exclusion Criteria:

- Concomitant disease which may adversely affect the outcome

- Poor nutritional status

- Medical or psychological condition precluding treatment

- Previous treatment

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To asses the feasibility of high dose rate brachytherapy

Principal Investigator

Shyamkishore J Shrivastava, MD, DNB (RT)

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor & Head, Radiation Oncology, Tata Memorial Hospital


India: Department of Atomic Energy

Study ID:

TMH/11062/1996/Cx_HDR STUDY



Start Date:

May 1996

Completion Date:

January 2007

Related Keywords:

  • Cancer of Cervix
  • Cervical Cancer
  • Cancer of the Cervix
  • Cervix Cancer
  • Cerivcal Cancer
  • High Dose Rate (HDR) Brachytherapy
  • Low Dose Rate (LDR) Brachytherapy
  • Acute Toxicities
  • Late Radiation Sequelae
  • Carcinoma
  • Uterine Cervical Neoplasms