Clinical trial NCT00193830: High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
Official title: High Dose Rate (HDR) Versus Low Dose Rate (LDR) Brachytherapy in Carcinoma Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cancer of Cervix
Cervical Cancer
Cancer of the Cervix
Cervix Cancer
Keywords: Cervical Cancer
High Dose Rate (HDR) Brachytherapy
Low Dose Rate (LDR) Brachytherapy
Acute Toxicities
Late Radiation Sequelae
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2005-09-19
Enrollment: 750
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: To asses the feasibility of high dose rate brachytherapy
measure: To compare the early and late reactions of high dose rate brachytherapy in contrast with low dose rate brachytherapy.
measure: To compare the over-all survival and disease free survival in the two regimens.
Secondary outcomes:
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharastra
Study officials:
affiliation: Professor & Head, Radiation Oncology, Tata Memorial Hospital
name: Shyamkishore J Shrivastava, MD, DNB (RT)
role: PRINCIPAL_INVESTIGATOR
References: