Neoadjuvant Chemotherapy Followed by Surgery Versus Concurrent Chemoradiation in Carcinoma of the Cervix

NCT00193739 | Unknown Phase 3 DMC

• 1 other identifier: 119 of 2003
• Study Type: interventional
• Target: 635
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer of Cervix

Keywords

Neoadjuvant chemotherapy; Surgery; Cervix cancer; Concurrent chemoradiation

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  Disease free survival will be calculated from the date of entry into the study to the date of first physical or radiographic evidence disease relapse or death due to disease or last follow up visit.

  5 years

Secondary Outcomes (2)

• Over all survival

  7 years

• Rate of Distant Metastases

  7 years

Study Arms (2)

NACT followed by surgery

ACTIVE COMPARATOR

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)

Drug: NACT; Procedure: Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling

Concurrent chemoradiotherapy

ACTIVE COMPARATOR

Radiation therapy will be administered to whole pelvis followed by intracavitary brachytherapy. Patients will be given chemotherapy (Inj.Cisplatin) concurrently with external beam radiotherapy.

Drug: Inj.Cisplatin; Radiation: Concurrent chemo radiotherapy

Interventions

NACT DRUG

3 cycles of neoadjuvant chemotherapy

Also known as: Neoadjuvant chemotherapy (Inj.Paclitaxel + Inj.Carboplatin)

NACT followed by surgery

Radical abdominal hysterectomy (class III), BPLND & lower para aortic lymph node sampling PROCEDURE

NACT followed by surgery

Also known as: Radical abdominal hysterectomy (class III), bilateral pelvic lymphadenectomy & lower para aortic lymph node sampling

NACT followed by surgery

Inj.Cisplatin DRUG

Concurrent chemo radiotherapy

Concurrent chemoradiotherapy

Concurrent chemo radiotherapy RADIATION

Radiation therapy will be administered to the whole pelvis region followed by intracavitary brachytherapy.

Also known as: External beam radiotherapy followed by intracavitary brachytherapy. (EBRT + ICA)

Concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with histologically proven invasive squamous cell carcinoma of the uterine cervix, stages IB2-IIB.
• Age 18-65 years (both inclusive)
• No evidence of visceral, skeletal or extra-abdominal nodal metastases.
• No history of prior or present second malignancy
• Good performance status (Karnofsky performance score \> 70 or ECOG PS \<2)
• Normal hematological \& biochemical parameters including normal renal function.
• Presence of associated co-morbid conditions that preclude participation in the study.
• No prior treatment.
• Informed consent for participation in the study.

Sponsors & Collaborators

• Tata Memorial Hospital: lead

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400012, India

Location

Related Publications (2)

• 928O_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

  RESULT

• Gupta 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 RESULT

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Sudeep Gupta, MD, DM

  Tata Memorial Hospital, Mumbai-400012,India

  PRINCIPAL INVESTIGATOR

• Shyam K Shrivastava, MD

  Tata Memorial Hospital, Mumbai-400012, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Oncology

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 19, 2005
• Study Start: September 4, 2003
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 20, 2019

Record last verified: 2019-09

Locations

IN (1)