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NCT05384366
Neoadjuvant Chemotherapy in Cervical Cancer
Phase 3 trial testing Neoadjuvant chemotherapy in Cervix Cancer in 33 participants. Completed in 31 March 2022.
31 March 2022
Quick facts
| Lead sponsor | Banaras Hindu University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 August 2020 |
| Primary completion | 31 March 2022 |
| Estimated completion | 31 March 2022 |
| Sites | 1 location across India |
Drugs / interventions tested
- Neoadjuvant chemotherapy — full drug profile →
Conditions studied
- Cervix Cancer — all drugs for Cervix Cancer →
- Cervical Cancer — all drugs for Cervical Cancer →
- Cancer of the Uterine Cervix — all drugs for Cancer of the Uterine Cervix →
Sponsor
Banaras Hindu University
Who can join
Adults 18 to 100, female only, with Cervix Cancer or Cervical Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Cervical cancer represents the second commonest cancer in women worldwide, with 500,000 new cases and 300,000 deaths reported yearly. Among cervical cancer cases, 80% occur in developing countries and about 70% are identified as advanced cancer. According to the International Federation of Gynecology and Obstetrics (FIGO) staging system, a locally advanced cervical cancer includes stage IB2 to IIB. Treatment modalities include radical surgery with or without adjuvant radiotherapy (RT), Neoadjuvant Chemotherapy (NAC) plus radical hysterectomy with or without adjuvant RT, and concomitant chemo radiation. Currently, platinum based concurrent chemoradiotherapy is the gold standard for locally advanced cervical carcinoma. Neoadjuvant chemotherapy has many advantages: decreasing tumor size making surgery easier with improved rate of complete resection, decreased pelvic recurrence rate significantly, decreasing rate of parametrial invasion and lymph node metastasis, better brachytherapy distribution, minimal radiation toxicity, and 15% absolute increase of 5-year survival. This study will evaluate various factors i.e. patient related (Age, Menopausal status, HPV, HIV, Comorbidities), Tumor related pathological stages (TNM), grade, lymphovascular perineural invasion, lymph nodes, extranodal extension, tumor margins including radial margin, type of tumor i.e. Adeno vs squamous, mutation profile and Treatment related factors (type of NAC, duration of NAC, no of cycles of NAC).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05384366
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Other recruiting trials for Cervix Cancer
Currently open trials in the same condition.
- NCT07276360 — Hypofractionated Radiotherapy for the Treatment of Locally Advanced Cervical Cancer in Uganda · Phase 2 · recruiting
- NCT07292818 — Hyaluronic Acid-based Gel Spacers in Gynecologic Malignancies · Phase 1 · recruiting
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- NCT06904365 — Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women · recruiting
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Other Banaras Hindu University trials
Trials by the same sponsor.
- NCT05865548 — Addition of Aspirin to Standard of Care in Oral Cancer · Phase 2, PHASE3 · completed
- NCT05833815 — Addition of Everolimus to Standard of Care in Carcinoma Gallbladder · Phase 2, PHASE3 · recruiting
- NCT05240378 — Mortality of Cancer Surgery During SARS CoV2 Pandemic · completed
- NCT05404334 — of Androgen Receptor Expression in Breast Cancer With or Without BRCA Mutation · completed
- NCT05833841 — Swallowing Function in Patients With Head and Neck Cancers · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05384366 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Banaras Hindu University
- Last refreshed: 20 May 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05384366.
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