Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

Conditions

Cancer Cervix

Keywords

IGRT,Postoperative, Cervix, Late toxicity, Bowel

Brief summary

The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.

Detailed description

Postoperative pelvic radiotherapy (+/- chemotherapy) leads to reduction in the risk of local recurrence and improves progression free survival (PFS) in patients with post-operative intermediate and high risk factors following Wertheim's hysterectomy. However, adjuvant external beam radiotherapy and vaginal cuff brachytherapy increase the risk of small bowel toxicity such that patients undergoing external beam pelvic radiotherapy and vaginal cuff brachytherapy may have 15-18% incidence of late RTOG ≥ grade II small bowel toxicity. Phase II studies using new techniques like Intensity Modulated Radiotherapy (IMRT) have reported up to 50% reduction in small bowel doses with up to 30% reduction in ≥ grade II acute toxicity. However, there is no randomized data demonstrating the benefit of highly specific and conformal techniques like image guided (IG)-IMRT in reducing radiation induced small bowel toxicity in patients with cervical cancers. The present study is being proposed to test if use of IG-IMRT with Tomotherapy is associated with reduced small bowel late toxicity

Supriya C, Nilesh R, Mayuri C, Sadhana K, Reena E, Tapas D, Lavanya G, Prachi M, Amita M, Shylasree TS, Shyam S, Sudeep G.

2022-10-183 citations

10.1016/j.radonc.2022.10.013

Months and Severity Score (MOSES) in a Phase III trial (PARCER): A new comprehensive method for reporting adverse events in oncology clinical trials.

Ranjan N, Chopra S, Mangaj A, Rane P, Charnalia M, Kannan S, Dora T, Engineer R, Mahantshetty U, Gurram L, Mittal P, Ghosh J, Maheshwari A, Shylasree TS, Gupta S, Shrivastava SK.

2022-04-166 citations

10.1016/j.eclinm.2022.101390

Patterns of Relapse After Adjuvant Chemoradiation for Cervical Cancer in a Phase 3 Clinical Trial (PARCER): An Evaluation of Updated NRG Oncology/RTOG Target Delineation Guidelines.

Mittal P, Chopra S, Charnalia M, Dora T, Engineer R, Mulani J, Scaria L, Prajapati K, Kannan S, Gurram L, Mahantshetty U, Gupta S, Shrivastava SK.

2022-02-123 citations

10.1016/j.ijrobp.2022.02.007

Acute hematological toxicity during post-operative bowel sparing image-guided intensity modulated radiation with concurrent cisplatin

Shirley Lewis, Supriya Chopra, Pushpa Naga, Siddharth Pant, E. Dandpani et al. (12 authors)

British Journal of Radiology2018-09-0420 citations

10.1259/bjr.20180005

Evaluation of interobserver and interscale agreement in assessing late bowel toxicity after pelvic radiation in patients with carcinoma of the cervix.

Chinnachamy AN, Chopra S, Krishnatry R, Kannan S, Thomas B, Mahantshetty U, Engineer R, Shrivastava SK.

2013-03-2017 citations

10.1093/jjco/hyt028

Interventions

RADIATIONConventional Radiation

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

RADIATIONTomotherapy based IGRT

Patients in this arm will received Tomotherapy based Image Guided Intensity Modulated Radiotherapy to a dose of 50 Gy/25 fractions/5 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

No masking. This is a open-label study.

Intervention model description

Patients enrolled are randomized to either conventional arm or tomotherapy arm for treatment after stratification according to type of surgery the patient underwent and the indication of chemotherapy along with radiation

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features. * Age \>18 years. * Planned for Wertheim's hysterectomy or has already undergone Wertheim's hysterectomy OR has undergone Simple Hysterectomy with no evidence of residual nodes on MRI/PET imaging+/- confirmatory nodal biopsy. * No evidence of paraaortic nodal metastasis.

Exclusion criteria

* History of multiple previous abdominal surgeries placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder. * Rectal Polyps or extensive hemorrhoids.

Design outcomes

Primary

Measure	Time frame	Description
Late bowel toxicity ≥ Grade II	Median follow up of 3 years	Time to event and severity of late bowel toxicity are assessed

Secondary

Measure	Time frame	Description
To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity	Median follow up of 3 years	Data on dosimetric analysis of small bowel dose in reference to volume are collected in both arms and assessed for predicting dose prescription for ≥ grade II late bowel toxcity
To evaluate acute toxicity difference in two study arms using CTCAE version 3.0	Within 90 days	Acute toxicity will be reported using CTCAE V.3.0. CTCAE forms will be filled before starting radiation, weekly during radiation treatment and on each scheduled follow-up. If any toxicity occurs at another time point additional forms will be filled to capture the same. Acute toxicity difference will be calculated between the two study arms.
Preoperative functional imaging features that predict for local and distant recurrence will be identified	3 years after completion of accrual	Images acquired pre-operatively are analysed for features that predict local and distant recurrence.
To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30	3 years from completion of accrual	Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation . EORTC QLQC30 module will be used for evaluating QOL of patients. QOL scoring will be done as per standard recommendations outlined in EORTC QLQ C30 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up. Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4. 1 will be considered as better outcome \& 4 will be considered as worst outcome.
To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24	3 years from completion of accrual	Assessment is done for all enrolled patients to compare the quality of life after treatment with tomotherapy and conventional radiation. EORTC QLQCX24 module will be used to assess disease-specific and treatment-specific aspects of QoL in patients with cervical cancer. CX24 QOL scoring will be done as per standard recommendations outlined in EORTC QLQ CX24 scoring manual. All patients will undergo QOL evaluation at baseline, after treatment and at subsequent follow-up. Scale- Not at all-1 , A little Bit-2, Quite a bit-3, very much-4. 1 will be considered as better outcome \& 4 will be considered as worst outcome.

Countries

India

Contacts

PRINCIPAL_INVESTIGATORSupriya Chopra, MD,DNB

ACTREC, Tata Memorial Centre

Outcome results

None listed