Comparison of two different Radiotherapy techniques for the treatment of Cervical Cancer

Phase 2

Completed

• Conditions: Health Condition 1: null- CARCINOMA CERVIXHealth Condition 2: C539- Malignant neoplasm of cervix uteri, unspecified

• Registration Number: CTRI/2018/05/014118
• Lead Sponsor: GHRITASHEE BORA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Histologically proven cervical cancer patients.

2.Stage II A to IV A

3.Age 18 â?? 65 years

4.Karnoffskyâ??s Performance Scale(KPS) score >70.

5.Patients with adequate Bone Marrow ,renal and hepatic function(to be obtained <14 days prior to registration).

Haemoglobin >10 gm/dl.

WBC >4000/mm³

ANC >1500cells/mm³

Platelets >100,000cells/mm³

Creatinine Clearance >50 ml/min

6.Prior to registration CT/MRI of abdomen and pelvis must be performed.

7.Chest X ray should be performed prior to treatment.

8.Patient must sign a study-specific informed consent.

Exclusion Criteria

1.Distant metastasis discovered by clinical or imaging examination.

2.Bladder control problems that make the patient unable to comply with Bladder filling protocols.

3.Prior Radiation Therapy to the pelvis that would result in overlap of radiation therapy fields.

4.Patients with serious active co-morbidities defined as-

Unstable Angina and/or Congestive heart failure requiring hospitalisation within last 6 months.

Trans mural myocardial infarction within last 6 months.

Exacerbation of COPD/ other respiratory illness requiring hospitalisation at the time of registration.

Hepatic insufficiency resulting in clinical jaundice.

AIDS based upon current CDC definition.

5.Cervical cancer patients with prior treatment with Platinum based Chemotherapy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dosimetric analysis of Bone Marrow Sparing IMRT and 4 field conformal technique <br/ ><br>with concurrent Chemotherapy. <br/ ><br>Assessment of toxicity profile which will include- <br/ ><br> Haematological toxicity. <br/ ><br> Acute GI toxicities. <br/ ><br> Genitourinary toxicities. <br/ ><br>Timepoint: Dosimetric analysis of Bone Marrow Sparing IMRT and 4 field conformal technique <br/ ><br>with concurrent Chemotherapy. <br/ ><br>Assessment of toxicity profile which will include- <br/ ><br> Haematological toxicity. <br/ ><br> Acute GI toxicities. <br/ ><br> Genitourinary toxicities. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
- Comparision of toxicities of Bone Marrow Sparing IMRT versus four field conformal technique with concurrent Chemotherapy. <br/ ><br> <br/ ><br>Timepoint: -AT THE END OF LAST PATIENT ACCRUAL(1 YEAR)