A clinical trial to study the role of chemotherapy followed by radiotherapy to spare the bone marrow in carcinoma cervix patients with advanced disease

Extended field bone marrow sparing image guided intensity modulated (BMS IG-IMRT) chemoradiation with dose dense neoadjuvant chemotherapy in carcinoma cervix with para-aortic lymphadenopathy: a phase II study - BICEP

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050592

Enrollment

Registered

2023-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteri

Interventions

Intervention1: 1) Neoadjuvant Chemoradiotherapy (Week 1-6) 2) Concurrent chemotherapy with radiation 3) Radiotherapy: External beam radiotherapy followed by brachytherapy: 1) Neoadjuvant Chemoradiothe

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed carcinoma cervix 2. Stage IIIC2 disease confirmed by radiology or pathology as per FIGO 2018 staging 3. Baseline MRI Pelvis, 18FDG PET CT (preferably in radiotherapy treatment position) 4. ECOG performance status, no contraindications to neoadjuvant or concurrent chemotherapy 5. Signed informed consent 6. Highest level of involved para-aortic lymph node: L1 7. Adequate end organ function (hepatic, renal, cardiac) reserve

Exclusion criteria

Exclusion criteria: 1. Other histology: melanoma, small cell, basal cell carcinoma 2. Previous pelvic radiotherapy, hysterectomy, any form of oncological treatment 3. Contraindications to CEMRI, brachytherapy 4. Age less than 18 years 5. Uncontrolled medical comorbidity

Design outcomes

Primary

Measure	Time frame
acute hematologic, GI toxicity (more than or equal to Grade 3)Timepoint: 30 days	—

Secondary

Measure	Time frame
1. To assess response rates post treatment using RECIST, PERCIST criteriaTimepoint: 3 months;2. To assess survival outcomes: overall survival, progression free survival, locoregional control Timepoint: 1 year;3. To assess acute and late radiotherapy and chemotherapy toxicities (after neoadjuvant chemotherapy and completion of chemoradiation)Timepoint: 3 monthly intervals from treatment completion to 1 year;4. To evaluate health related quality of life at specified time pointsTimepoint: 3 monthly intervals from treatment completion to 1 year;5. To correlate organs at risk (OAR) dosimetry with radiotherapy toxicityTimepoint: 3 monthly intervals from treatment completion to 1 year;6. To investigate the relationship between pre-treatment absolute lymphocyte count (ALC) and overall survivalTimepoint: 1 year	—

Measure

Time frame

1. To assess response rates post treatment using RECIST, PERCIST criteriaTimepoint: 3 months;2. To assess survival outcomes: overall survival, progression free survival, locoregional control Timepoint: 1 year;3. To assess acute and late radiotherapy and chemotherapy toxicities (after neoadjuvant chemotherapy and completion of chemoradiation)Timepoint: 3 monthly intervals from treatment completion to 1 year;4. To evaluate health related quality of life at specified time pointsTimepoint: 3 monthly intervals from treatment completion to 1 year;5. To correlate organs at risk (OAR) dosimetry with radiotherapy toxicityTimepoint: 3 monthly intervals from treatment completion to 1 year;6. To investigate the relationship between pre-treatment absolute lymphocyte count (ALC) and overall survivalTimepoint: 1 year

—

Countries

India

Contacts

Public ContactDr Namrata Das

AIIMS, New Delhi

namrata747@gmail.com8280249251

Outcome results

None listed

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