About this trial
This is a combination of retrospective and prospective observational study that will be performed across NCG and other participating centers to report compliance to chemoradiation for cervical cancer. This audit will include patients treated with standard of care treatment, in this case definitive or adjuvant radiation+/- concurrent chemotherapy will be included. Patients recruited in various institutions in prospective clinical trials will not be included. The participating centersthat agree to contribute data will include all registered cases over a 6-month period that have been diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and/or concurrent chemotherapy. Centers that do not have retrospective data of the patients will contribute data of patients registered prospectively over 6 months. Furthermore, any cases referred to the institution for brachytherapy alone will also be included.
As a first step member institutions that participated in guideline development process or provide an agreement to guidelines adherence will be audited. The project will be submitted in institutional ethics committees with memorandum of understanding for anonymized data sharing.
Each of the co-investigators listed from contributing centers will be directly responsible for collecting data contribution and accuracy of data submitted.
Those centres which cannot or do not want to participate will be requested to provide data on only compliance outcomes to treatment for at least of 5 consecutively patients diagnosed with cervical cancer wherein treatment is planned with radical dose radiation and /or concurrent chemotherapy over a period of 6 months.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The participating centers that agree to contribute data will include all registered cases over a 6 month period that have been diagnosed with histologically proven cervical cancer wherein either radical, adjuvant or palliative radiation with or without concurrent or systemic chemotherapy is planned. Furthermore any cases referred to the institution for brachytherapy alone will also be included.
Trial design
Case-only
Other
Treatments tested in this trial
Not applicable- observational study
Other interventionCompliance to Cervical Cancer Chemoradiation treatment guidelines
Treatment groups
Trial outcomes
Primary outcomes
report on institutional compliance to National Cancer Grid cervical cancer guidelines for chemo-radiation.
To report praportion of patients with No deviation, Major \& Minor Deviation and unacceptable deviation for chemoradiation guidlines.
Secondary outcomes
To report on factors impacting compliance to standard guidelines
To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin
To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits
Sponsors and contacts
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Tata Memorial Hospital
Lead sponsor
Tata Memorial Centre
Sponsor institution
Post Graduate Institute of Medical Education and Research, Chandigarh
Collaborator
MNJ Institute of Oncology and Regional Cancer Center
Collaborator
Christian Medical College, Vellore, India
Collaborator