A Pilot project to study the feasibility of interdigitating High Dose Rate brachytherapy with Concurrent Chemoirradiation in Carcinoma Cervix

AIM OF THE STUDY: Primary objectives: 1. To assess the feasibility of interdigitating High Dose Rate (HDR) brachytherapy with External Radiotherapy. 2. To evaluate the acute toxicity of interdigitating HDR brachytherapy with external radiotherapy during the period of treatment. 3. To study the reasons for not being able to interdigitate brachytherapy with the external beam radiotherapy. Secondary objective: 1. To assess the possibility of reduction in overall treatment time. MATERIALS AND METHODS: All patients who have come to the Department of Radiotherapy with biopsy proven carcinoma cervix were considered for the participation in the trial. They were enrolled after signing the informed consent. Inclusion Criteria: The patients were screened for the following inclusion criteria and then enrolled. 1. Carcinoma cervix stage IIA to IIIB with Histological confirmation (squamous cell, adenocarcinoma, and adenosquamous carcinoma). 2. ECOG Performance Status score 0-2. 3. Adequate bone marrow function: White Blood Cells > 3000/mm3 (ANC ≥ 1800/mm3); platelets > 100,000 mm3; 4. Adequate renal function: Creatinine < 1.5 mg/dl (urinary diversion is permitted to improve renal function); patients must have Bilirubin < 1.5 mg/dl, ALT / AST ≤ 2 x normal Alkaline phosphatase. Should give an informed consent prior to participation in study. 5. People of child bearing potential should be willing to practice contraception. 6. Patients responding to radiation therapy and subsequently treated with brachytherapy, were included for analysis. Exclusion Criteria: 1. Previous history of tumor-directed surgery, 2. Previous history of systemic chemotherapy, 3. Previous history of pelvic radiation therapy, 4. Pregnancy, 5. Presence of Metastatic disease, 6. Severe co morbid medical condition. Patients who did not respond to radiation therapy and therefore subsequently could not be treated with brachytherapy were not considered for analysis. RESULTS: From the month of May 2009 to November 2009, 72 patients were newly registered with the diagnosis of carcinoma cervix. Some were referred cases, some were treated elsewhere and come for follow up and some came only for evaluation and confirmation of diagnosis. Among these patients 39 were evaluated for treatment and screened for eligibility to be included in the study out of which 27 patients were enrolled after their informed consent. Four of these patients have not completed the therapy therefore not included in the analysis. Following enrollment 4 patients withdrew from the study; another 2 defaulted while 1 patient was a screen failure. CONCLUSIONS: In this pilot project done to study the feasibility of interdigitating HDR brachytherapy with Concurrent Chemoirradiation in carcinoma cervix, it was found that there was acute toxicity-hematological toxicity, radiation induced dermatitis and vaginal mucositis which caused significant delay in the completion of the treatment. The various reasons for not being able to interdigitate brachytherapy with external beam radiotherapy was; 1. Grade 3 and 4 neutropenia, 2. Grade 3 radiation induced dermatitis and vaginal mucositis, 3. Inadequate response to concurrent chemoirradiation, 4. Acute radiation proctitis. With the regime used in our study of 4 cycles of concurrent chemotherapy with cisplatin 40 mg per square meter along with weekly once HDR brachytherapy of 7.2 Gy to point A interdigitating with external radiotherapy only 4 of the 13 patients completed within 8 weeks and none of them completed within the planned 7 weeks. So a reduction in overall treatment time that was aimed for could not be achieved. Another option that could be tried is to carry out 2 brachytherapy applications with higher dose instead of the 3 fractions as used in this study with a better tolerance and possibility of reducing the overall treatment time. Another advantage of using fewer fractions of brachytherapy would be patient convenience and improved patient compliance