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A study to compare the effect of adding chemotherapy before radiotherapy versus only radiotherapy in node positive cervical cancer patients

Induction chemotherapy followed by chemo-radiotherapy versus chemo-radiotherapy alone in node positive cervical carcinoma: a prospective randomised comparative study - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109745
Enrollment
72
Registered
2026-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

Interventions

Intervention1: NEOADJUVANT CHEMOTHERAPY: NEOADJUVANT CHEMOTHERAPY WITH DRUGS PACLITAXEL 175mg/m2 AND CARBOPLATIN(AUC 5) 3 WEEKLY SCHEDULE FOR 3 CYCLES Control Intervention1: Standard definitive chemo-

Sponsors

DR DEBARSHI LAHIRI
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed squamous, adeno or adeno-squamous carcinoma of the cervix and radiologically confirmed FIGO stage IIIC1 and IIIC2 2. Deemed suitable and fit for chemotherapy & radiotherapy 3. ECOG performance status 0 2 4. Aged 18 70 years 5. Adequate hematological and biochemical parameters 6. A documented negative pregnancy test and using adequate contraception precautions 7. Capable of providing written or witnessed informed consent and no mental illness.

Exclusion criteria

Exclusion criteria: 1.Previous history of any malignancy 2. Any major Pelvic/lower abdominal surgery 3. Evidence of non regional nodal metastasis, visceral or skeletal metastasis 4. Bladder and rectal involvement 5. Previous pelvic radiotherapy 6. Known case of Inflammatory bowel disease

Design outcomes

Primary

MeasureTime frame
Improvement in the disease free survival and response eate by adding induction chemotherapy prior to definitive chemo-radiotherapy in node positive cervical cancer with acceptable toxicitiesTimepoint: At 3 MONTHS, 6 MONTHS AND 9 MONTHS FOLLOW UP

Secondary

MeasureTime frame
Improved nodal response with the addition of induction chemotherapyTimepoint: 1 week after the end of neoadjuvant chemotherapy 3 cycles

Countries

India

Contacts

Public ContactDR DEBARSHI LAHIRI

CHITTARANJAN NATIONAL CANCER INSTITUTE

debarshil@gmail.com9051513564

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026