A Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix

NCT00193804 | Completed DMC

• 1 other identifier: TMH/158/2004/Cx_IMRT TRIAL
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

A study to evaluate the efficacy of Intensity Modulated Radiation Therapy (IMRT) as compared to Standard Conventional Radiotherapy Alone in the treatment of carcinoma cervix. Concomitant Weekly Cisplatin chemotherapy will be given as a routine, which is a standard of care today for early stage cervical cancers including stage IIB. The benefits of using IMRT in reducing radiation-induced toxicity are well known. Since this treatment modality has not yet been validated and studied in a randomized trial setting, the present study is being undertaken. The study arm of IMRT has the potential to reduce the toxicities by 15-20%, but is associated with labor intense procedure requiring many hospital visits before actual start of treatment.

Conditions

Cancer of Cervix

Keywords

Cervical Cancer; FIGO STAGE IIB; CHEMORADIATION; Intensity Modulated Radiation Therapy(IMRT); Conventional Radiation Therapy; Cancer of the Cervix; Cervix Cancer

Outcome Measures

Primary Outcomes (1)

• To compare the normal tissue toxicities (Acute & Late) of standard radiation therapy with IMRT

  2017

Secondary Outcomes (3)

• To compare the disease free survivals

  2017

• To compare the quality of life in both the groups

  2017

• To compare the overall survivals

  2017

Study Arms (1)

2

Patients with histologically proven, cervical cancer FIGO Stage IIB eligible will be invited for the study. The patients will recieve either 3D conformal radiation or IMRT external radiation with concomitant cisplatin chemotherapy followed by brachytherapy.

Radiation: IMRT

Interventions

IMRT RADIATION

IMRT in cervical cancers

2

Eligibility Criteria

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

Study Population

Patients with histologically proven cervical cancers, FIGO Stage IIb eligible for the study will be invited for the study

You may qualify if:

• Histologically proven squamous carcinoma or adenocarcinoma of cervix
• Performance index WHO grade 0 or 1
• Patients below 65 years of age
• FIGO Stage IIB
• Normal ECG and Cardiovascular system
• Normal hematological parameters
• Normal renal and liver function tests

You may not qualify if:

• Co-morbid conditions like medical renal disease
• Medical or Psychological condition that would preclude treatment
• H/o Previous treatment / Pregnancy
• Patient unreliable for treatment completion and follow-up.

Sponsors & Collaborators

• Tata Memorial Hospital: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400 012, India

Location

Related Links

• Tata Memorial Hospital

MeSH Terms

Conditions

Uterine Cervical Neoplasms

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

Study Officials

• Shyamkishore J Shrivastava, MD, DNB (RT)

  Professor & Head, Radiation Oncology, Tata Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. & Head of Radiation Oncology

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2005
• Primary Completion: June 20, 2017
• Study Completion: June 30, 2019
• Last Updated: September 16, 2019

Record last verified: 2019-09

Locations

IN (1)