ACUTE TOXICITY OF EXTENDED FIELD INTENSITY MODULATED RADIOTHERAPY AND CONCURRENT CHEMOTHERAPY IN HIGH RISK CERVICAL CANCER PATIENTS

Phase 2

Completed

Conditions: carcinoma cervix

Registration Number: CTRI/2018/01/011599

Lead Sponsor: PGIMER

Brief Summary: Cervical cancer is the second leading malignancy in Indian women. Majority of the cervical cancer cases present to us in locally advanced stage. Concurrent chemo radiation is the treatment of choice for these patients. However many treatment failures occur in the para aortic region. It is hypothesised that these failures are due to the pre existing subclinical micrometastatic disease in the para aortic lypmh nodes which are not addressed by local pelvic RT ot concurrent chemotherapy given as a standard treatment.

The challenge is in identifying these patients who harbor micrometastatic disease in para aortic region. Lymph node dissection is the standard investigation that can identify these patients. However it is not possible in all patients because of the morbidity of the surgical staging procedure when cobined with post operative radiotherapt and also due to logistics.

PET-CT has been shown to identify these patients. more so PET-CT has shown that patient with pelvic lymph node metastases have greater risk of having para aorrtic lymph node metastases.

Our study is aimed at dientifyying these subset of patients with the help of PET-CT ,and then treating them with extended field radiotherapy plus concurrent cisplatin in contrast to the standard Pelvic RT+ CCT.

Acute toxiciy is a major concern with such a large field. Acute toxicity reported during treatment and 6 weeks after completion will be used as a surrogate to assess the feasibility of this approach in our setup.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 15

Inclusion Criteria

1.Previously untreated, biopsy proven squamous cell carcinoma of cervix stage IB2-IIIB 2.Para aortic nodes negative and pelvic lymph node positive on FDG PET scans 3.Karnofsky performance scale > 70 (annexure-VII) 4.Pre treatment parameters :- a)Hemoglobin>10gm/dl b)TLC >4000/mm3 c)Platelets > 100000/mm3 d)Blood urea < 40 mg/dl e)Serum creatinine < 1.2mg/dl f)Normal Chest X-ray 5.Patients willing to give informed consent and agreeing for follow up.

Exclusion Criteria

1.All post operative cases 2.History of prior pelvic radiotherapy 3.Patients having any uncontrolled co morbid conditions.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To assess acute toxicity of extended field intensity modulated radiotherapy concurrent chemotherapy in patients of cervical cancer with PET positive pelvic lymph nodes.	WEEKLY ASSESSMENT OF ACUTE TOXICITY DURING TREATMENT \| ASSESSMENT OF TOXICITY AFTER 6 WEEKS OF COMPLETE TREATMENT

Secondary Outcome Measures

Name	Time	Method
late toxicity of treatment	1 year post treatment

Trial Locations

Locations (1): PGIMER CHANDIGARH
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER CHANDIGARH
🇮🇳Chandigarh, CHANDIGARH, India
Nagarjun Ballari
Principal investigator
9781882345
nagarjunballari@gmail.com