Compliance to Cervical Cancer Chemoradiation Guidelines: A Multicentric Implementation Audit and Resource Assessment Initiative of National Cancer Grid of India

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorTata Memorial Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

  • Not applicable- observational study

    Other intervention

    Compliance to Cervical Cancer Chemoradiation treatment guidelines

Treatment groups

618 Participants
are divided into 1 treatment group
Group A: Patients diagnosed with Cervical Cancer1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 Months

Secondary outcomes

1

To report on factors impacting compliance to standard guidelines

Time frame
3years
2

To report adequacy of infrastructural and manpower requirements for optimal treatment of cervical cancer in NCG centres and corresponding state of origin

Time frame
3 years
3

To compute relative risk of suboptimal treatment for cervical cancer in reference to infrastructural and manpower deficits

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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