- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193804
A Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix
A Phase II Randomized Trial Comparing Intensity Modulated Radiation Therapy (IMRT) With Conventional Radiation Therapy in Stage IIB Carcinoma Cervix
Study Overview
Detailed Description
Carcinoma Cervix is the commonest malignancy seen in Indian women and constitutes approximately 10% of all cancers at Tata Memorial Hospital (1). It is also the leading cause of cancer mortality in India. Nearly 85% of the patients present with advanced stages (FIGO Stage II/III). The main stay of treatment has traditionally been radical radiation therapy with 80-90% of patients requiring radiation in their lifetime and over decades the survival rates have achieved a plateau of 30 - 55% at 5 years.
Radiation therapy is usually a combination of external beam and intracavitary brachytherapy. External beam radiation includes irradiation of primary tumor and nodal areas of risk. Higher Doses of external beam radiation is limited due to normal critical organs namely, small bowel, rectum and bladder. A major concern with pelvic radiation is the considerable volume of both small bowel and rectum is included in the radiation treatment fields. Unsurprisingly, gastrointestinal radiation reactions include diarrhea while late sequelae include small bowel obstruction, enteritis and diarrhea are common (2-4). The benefits of multiple fields, high energy beams, customized blocking and low fraction sizes are well known (4). Various methods have been used to reduce the small bowel complications. Surgical methods include absorbable meshes (5), tissue expanders (6) and omentoplasty (7). However, these approaches are not feasible in patients undergoing definitive radiation. Apart from small bowel toxicity, late rectal and bladder complications are also of a major concern. The clinical manifestations vary from mild proctitis, stricture, bleeding ulcers and fistula formation to hemorrhagic cystitis requiring cystectomy. Grade III radiation cystitis and proctitis reported are in the range of 3-15% with radiation alone.
Moreover, of late the pattern of practice is increasingly being emphasized on concomitant chemo radiation (8,9). The addition of chemotherapy though has no doubt improved the survivals, but has also led to increase in normal tissue toxicities. In the RTOG 90-01 and 92-10 there is alarming increase in the gastro intestinal (35% grade III and grade IV) and genitourinary (9% grade III and grade IV).
The changes in the treatment policies and the toxicities associated with wide pelvic radiation therapy demand for better normal tissue sparing radiation techniques or radioprotective agents. Three Dimensional Conformal Radiation Therapy (3D-CRT) to some extent has successfully achieved some normal tissue sparing. Intensity-modulated radiotherapy (IMRT) is an important recent advance in radiation therapy and is at the forefront of Translational Research. With 3DCRT the radiation intensity is generally uniform within the radiation portal whereas in IMRT the dose intensity within the portal varies with the use of beamlets, thereby allows a higher degree of conformation to the tumor than previously possible and allows concave isodose profiles to be generated.
Over last 10 years, IMRT has been successfully used in the treatment of prostate, head and neck and brain tumors. IMRT in pelvic radiation has the potential to reduce the dose as well as the volume of rectum, bladder and small bowel irradiated significantly and thereby translating into a decrease in the incidence and severity, of acute and late gastro-intestinal and genito-urinary toxicities. Several dosimetric studies have been reported to confirm the role of IMRT in reducing toxicities with pelvic radiation therapy (10,11). These dosimetric studies have reported that the volume of small bowel irradiated to the prescription dose by a factor of 2 compared with conventional radiation. The average volume of bladder and rectum irradiated is also reduced by 23% (12). In our series of 10 patients treated, IMRT in pelvic radiation therapy apart from reducing the hot spot volumes and better conformity index to the target volume, also significantly reduces the volumes of high dose regions in small bowel region (by 17%), rectum (by 50-60%) and bladder (by 40-50%) [unpublished data]. In another series of early report on outcome of 40 patients treated with IMRT to whole pelvis, Arno el al. have demonstrated that there is a significant reduction in acute radiation related toxicities, but it is too early to comment on late sequelae since the follow-up is short and has concluded that, this novel approach definitely needs to be validated in a trial setting. (13)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maharastra
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Mumbai, Maharastra, India, 400 012
- Tata Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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IMRT in cervical cancers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the normal tissue toxicities (Acute & Late) of standard radiation therapy with IMRT
Time Frame: 2017
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2017
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To compare the disease free survivals
Time Frame: 2017
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2017
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To compare the quality of life in both the groups
Time Frame: 2017
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2017
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To compare the overall survivals
Time Frame: 2017
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2017
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMH/158/2004/Cx_IMRT TRIAL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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Clinical Trials on Cancer of Cervix
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Tata Memorial HospitalCompletedCervical Cancer | Cervix Cancer | Cancer of Cervix | Cancer of the CervixIndia
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Duke UniversityWallace H. Coulter FoundationCompletedCancer of the Cervix, Cancer of the EndometriumUnited States
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Eli Lilly and CompanyCompletedCancer of CervixMexico, Thailand, Argentina, Bosnia and Herzegovina, India, Pakistan, Peru
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Newish Technology (Beijing) Co., Ltd.Recruiting
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Tata Memorial HospitalCompleted
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Women's Hospital School Of Medicine Zhejiang UniversityAkesoNot yet recruitingCervical Cancer | Uterine Cervical Neoplasms | Cancer of Cervix | Uterine Cervical Cancer | Cervical Neoplasms | Cancer of the Uterine Cervix
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Banaras Hindu UniversityCompletedCervical Cancer | Cervix Cancer | Cancer of the Uterine CervixIndia
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Bnai Zion Medical CenterUnknownInduction of Labor | Unfavorable CervixIsrael
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Fatma Ahmed Abdelfatah RikabeSohag UniversityNot yet recruiting
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Hillel Yaffe Medical CenterCompletedUnfavorable Cervix for Induction of LaborIsrael
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Royal Marsden NHS Foundation TrustCompleted
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University of Michigan Rogel Cancer CenterTerminatedBreast CancerUnited States
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Washington University School of MedicineTerminatedHead and Neck CancerUnited States
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Alberta Health servicesCompleted
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Jiangsu Cancer Institute & HospitalNot yet recruitingStage IVA Nasopharyngeal CarcinomaChina