Clinical trial · Interventional
Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix
A Prospective Randomized Trial of Neoadjuvant Chemotherapy and Surgery Versus Concurrent Chemoradiation Therapy in Patients With Stage IB2-IIB Squamous Carcinoma of the Uterine Cervix
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Carcinoma cervix is a common malignancy in women in developing countries including India. The standard treatment of locally advanced cervical cancer (Stages IB2 to IIIB)is concomitant chemoradiation (CT RT) using platinum based chemotherapy. Some studies, including a meta-analysis conducted by the Cochrane group, have indicated that few courses of neoadjuvant chemotherapy (NACT) followed by surgery may be superior to radical radiation alone for these patients. However NACT-Surgery approach has never been compared to the current standard of concomitant CT RT. The present study is undertaken to compare, in a randomized trial, NACT(3 courses of paclitaxel-carboplatin) followed by surgery to concomitant CT RT in stages IB2 to IIB squamous cell carcinoma of the uterine cervix.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer of Cervix | Malignant Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemo radiotherapy | Radiation | — | UNRESOLVED |
| Inj.Cisplatin | Drug | — | UNRESOLVED |
| NACT | Drug | — | UNRESOLVED |
| Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- NACT followed by surgery
- description
- 3 cycles of neoadjuvant chemotherapy (NACT) (Inj.Paclitaxel +Inj.Carboplatin) followed by surgery (radical abdominal hysterectomy Class III , bilateral pelvic lymphadenectomy \& lower para aortic lymph node sampling)
- interventionNames
- Drug: NACT
- Procedure: Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling
- type
- ACTIVE_COMPARATOR
- label
- Concurrent chemoradiotherapy
- description
- Radiation therapy will be administered to whole pelvis followed by intracavitary brachytherapy. Patients will be given chemotherapy (Inj.Cisplatin) concurrently with external beam radiotherapy.
- interventionNames
- Drug: Inj.Cisplatin
- Radiation: Concurrent chemo radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2-IIB. 2. Age 18-65 years (both inclusive) 3. No evidence of visceral, skeletal or extra-abdominal nodal metastases. 4. No history of prior or present second malignancy 5. Good performance status (Karnofsky performance score \> 70 or ECOG PS \<2) 6. Normal hematological \& biochemical parameters including normal renal function. 7. Presence of associated co-morbid conditions that preclude participation in the study. 8. No prior treatment. 9. Informed consent for participation in the study.
References
Publications (2)
- RESULT928O_PRNeoadjuvant chemotherapy followed by surgery (NACT-surgery) versus concurrent cisplatin and radiation therapy (CTRT) in patients with stage IB2 to IIB squamous carcinoma of cervix: A randomized controlled trial (RCT) S. Gupta P. Parab R. Kerkar U. Mahantshetty A. Maheshwari S. SastriR. Engineer R. Hawaldar J. Ghosh S. Gulia ... Show more Annals of Oncology, Volume 28, Issue suppl_5, 1 September 2017, mdx440.038,https://doi.org/10.1093/annonc/mdx440.038 Published: 18 September 2017
- RESULTGupta S, Maheshwari A, Parab P, Mahantshetty U, Hawaldar R, Sastri Chopra S, Kerkar R, Engineer R, Tongaonkar H, Ghosh J, Gulia S, Kumar N, Shylasree TS, Gawade R, Kembhavi Y, Gaikar M, Menon S, Thakur M, Shrivastava S, Badwe R. Neoadjuvant Chemotherapy Followed by Radical Surgery Versus Concomitant Chemotherapy and Radiotherapy in Patients With Stage IB2, IIA, or IIB Squamous Cervical Cancer: A Randomized Controlled Trial. J Clin Oncol. 2018 Jun 1;36(16):1548-1555. doi: 10.1200/JCO.2017.75.9985. Epub 2018 Feb 12. PMID 29432076