Individualisation of Dose Constraint in Radiotherapy of Gynaecological Cancer

Not Applicable

Conditions: Health Condition 1: C538- Malignant neoplasm of overlappingsites of cervix uteriHealth Condition 2: C548- Malignant neoplasm of overlappingsites of corpus uteriHealth Condition 3: C52- Malignant neoplasm of vagina

Registration Number: CTRI/2022/10/046309

Lead Sponsor: Tata Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Age > 18 years

ECOG performance status 0 - 2

Histologically confirmed malignancy of the uterine cervix, endometrium or the vagina requiring treatment with external beam radiotherapy to:

The whole pelvis ie. the primary tumor or tumor bed along with the pelvic lymph nodes (including the common iliac nodes).

The whole pelvis along with the para-aortic nodes - extended field radiotherapy.

Patients who require postoperative radiotherapy should have undergone a complete oncological surgical procedure and should have indication for adjuvant external beam radiotherapy.

Deemed suitable for curative intent treatment.

Absence of distant metastases excluding para-aortic nodes.

Exclusion Criteria

Patients receiving radiotherapy to the vulva. These patients are being excluded as they require treatment in a frog leg position and have a different volume of irradiation.

Patients who require elective irradiation of the inguinal nodes as these patients will require planning in the frog-leg position also.

Patients with ovarian malignancies - usually these patients do not undergo adjuvant or curative whole pelvic radiotherapy.

Patients who require radiotherapy for metastatic disease sites

Patients planned for re-irradiation to a previously irradiated site.

Patients who are planned for salvage radiotherapy to the para-aortic region.

Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety

Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of interest will be the proportion of patients in whom the system generated individualized dose constraints were more stringent than the usual dose constraints used for plan evaluation.Timepoint: At time of plan evaluation.

Secondary Outcome Measures

Name	Time	Method
Concordance between clinician and patient reported toxicityTimepoint: Every week during radiotherapy and at end of radiotherapy.;Counts and proportions of patients experiencing grade 2 or higher CTCAE toxicityTimepoint: Every week during radiotherapy and at end of radiotherapy;Dose difference between actual dose and dose constraints provided.Timepoint: At time of plan evaluation;Stringency of individualized dose constraintsTimepoint: At time of plan evaluation;The time required for the planning for each patient will be noted.Timepoint: At time of plan evaluation.