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

Dosimetric analysis and toxicity comparison of Bone Marrow sparing IMRT vs Four field Conformal technique with concurrent Chemotherapy for the treatment of Cervical Carcinoma -A Randomized Prospective Single Institutional Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/05/014118

Enrollment

Registered

2018-05-25

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: BONE MARROW SPARING IMRT: External Beam Radiotherapy to a dose of 50Gy/25# will be delivered using Bone marrow sparing IMRT technique alongwith concurrent Cisplatin followed by HDR Brac

Eligibility

Inclusion criteria

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 Haemoglobin >10 gm/dl. WBC >4000/mmÂ³ ANC >1500cells/mmÂ³ Platelets >100,000cells/mmÂ³ 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

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.

Design outcomes

Primary

Measure	Time frame
Dosimetric analysis of Bone Marrow Sparing IMRT and 4 field conformal technique with concurrent Chemotherapy. Assessment of toxicity profile which will include- Haematological toxicity. Acute GI toxicities. Genitourinary toxicities. Timepoint: Dosimetric analysis of Bone Marrow Sparing IMRT and 4 field conformal technique with concurrent Chemotherapy. Assessment of toxicity profile which will include- Haematological toxicity. Acute GI toxicities. Genitourinary toxicities.	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
- Comparision of toxicities of Bone Marrow Sparing IMRT versus four field conformal technique with concurrent Chemotherapy. Timepoint: -AT THE END OF LAST PATIENT ACCRUAL(1 YEAR)	—

Countries

India

Contacts

Public ContactGHRITASHEE BORA

DR.B.BOROOAH CANCER INSTITUTE

akkalita@yahoo.com9864035015

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026