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Radiotherapy and Concurrent chemotherapy along with or without previous chemotherapy in Advanced Cervical Cancer A Phase III Randomized Controlled Trial

Chemoradiation and Image guided Brachytherapy along with or sans Induction chemotherapy in Locally Advanced Cervical Cancer An Open labelled Phase III Randomized Controlled Trial (CASCADE Study) - CASCADE Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093924
Enrollment
328
Registered
2025-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: Arm A [NACT + CTRT]: Patients will receive induction chemotherapy in the form of Paclitaxel at 80mg/m2 and Carboplatin at AUC2 weekly for 6 weeks. Following 2-4 weeks of IC, patients wi

Sponsors

Institutional Intramural Funds
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Histologically proven invasive cancer of the uterine cervix squamous cell carcinoma adenocarcinoma or adeno-squamous carcinoma 2 FIGO 2018 stages IIB to IVA patients after clinical examination and imaging 3 ECOG performance status 0 to 1 4 Patient fit for curative intent treatment 5 Those who provide willingness to consent for participation in trial and follow up

Exclusion criteria

Exclusion criteria: 1 Patients with recurrent cervical cancers 2 Previous history of abdominal or pelvic radiation 3 Previous history of hysterectomy or major abdominopelvic surgery 4 History of connective tissue disorders 5 Patients with contraindications to undergo MR imaging like metallic prosthesis severe claustrophobia 6 Medical or psychological illness precluding treatment protocol including renal or hepatic dysfunction significant cardiac comorbidities which may preclude delivery of adequate doses of chemotherapy 7. Pregnant and breast-feeding women.

Design outcomes

Primary

MeasureTime frame
Disease Free SurvivalTimepoint: 3 years

Secondary

MeasureTime frame
Secondary endpoints with include 3 years OS and 3 years Distant Metastasis Free survival Patterns of Failure Quality of life assessment based on EORTC QLQ C30 and and EORTC QLQ CX24 questionnaire Acute and Late toxicities with CTCAE v5 Cost benefit analysis and compliance to full treatmentTimepoint: 3 years

Countries

India

Contacts

Public ContactDr Abhishek Shinghal

MPMMCC and HBCH Tata Memorial Centre Varanasi

abhishek.shinghal@gmail.com9595214343

Outcome results

None listed

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