Study of Maintenance Gefitinib Therapy in EGFR Positive Locally Advanced Squamous Cell Carcinoma of the Cervix

Role of Consolidated Gefitinib Therapy Following Standard Chemoradiotherapy in Locally Advanced EGFR-Positive Squamous Cell Carcinoma of the Cervix A Prospective Single Arm Study - CONGEF-CX Study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112765

Enrollment

Registered

2026-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: C53- Malignant neoplasm of cervix uteri

Interventions

Intervention1: Consolidated Gefitinib Therapy Following conventiona treatment in EGFR-Positive Carcinoma Cervix: EGFR IHC will be performed. EBRT Dose 45-50.4 Gy delivered in 25-28 fractions,1.8-2Gy p

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed squamous cell carcinoma of the cervix. 2. FIGO 2018 stage IB3 to IVA 3. Completed standard CCRT with brachytherapy 4 EGFR positive tumor, defined by immunohistochemistry or PCR on biopsy 5. ECOG Performance Status 0 to 2 6. Adequate organ function, Hb more than 10 g per dL, ANC more than or equal to 1500 per microL, Platelets more than or equal to 100,000 per microL, Serum creatinine less than 1.4 mg per dL and creatinine clearance more than 60 mL per min . 7. Signed informed consent .

Exclusion criteria

Exclusion criteria: 1. Distant metastases by imaging. 2. Prior systemic therapy, other than concurrent cisplatin or targeted therapy for cervical cancer. 3. Another active malignancy. 4. Pregnancy or lactation. 5. Uncontrolled comorbidities

Design outcomes

Primary

Measure	Time frame
To assess the safety and efficacy of gefitinib in EGFR-positive cervical cancer patients treated with standard chemoradiotherapy followed by consolidation gefitinib therapy.Timepoint: Monthly visits for 6 8 months while patients are on EGFR targeted therapy.	—

Secondary

Measure	Time frame
1. To assess the incidence of EGFR positivity rate in squamous cell carcinoma of cervix. 2. To evaluate the safety and tolerability of gefitinib consolidation by assessing acute and late treatment-related toxicities using RTOG/EORTC and CTCAE v5.0 criteria. 3. To monitor patient compliance during the consolidation therapy. 4. Disease free survival and progression free survivalTimepoint: After Completion of EGFR targeted therapy: Every 3 months for the first 2 years. Every 6 months for the next 3 years. Annually thereafter until 5 years.	—

Measure

Time frame

1. To assess the incidence of EGFR positivity rate in squamous cell carcinoma of cervix. 2. To evaluate the safety and tolerability of gefitinib consolidation by assessing acute and late treatment-related toxicities using RTOG/EORTC and CTCAE v5.0 criteria. 3. To monitor patient compliance during the consolidation therapy. 4. Disease free survival and progression free survivalTimepoint: After Completion of EGFR targeted therapy: Every 3 months for the first 2 years. Every 6 months for the next 3 years. Annually thereafter until 5 years.

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Countries

India

Contacts

Public ContactKavita Singh Verma

Department of Radiotherapy and Radiation Medicine, Institute of Medical Sciences, BHU, Varanasi

chandra1985@bhu.ac.in9454594003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026