Late Radiation Toxicities in Cervical and Endometrial Cancer: A Postoperative IMRT/Brachytherapy Study

Official title

Assessment of Late Gastrointestinal and Genitourinary Toxicities in Cervical and Endometrial Cancer Requiring Postoperative IMRT and/or Brachytherapy

Overview

Cervical cancer is the 4th most common cancer in women globally and the 2nd most common in India. In India, between 2018 and 2020, cervical cancer saw a surge of 26,985 from 2018 to 2020. The treatment for cervical cancer depends on the clinical stage. Treatment of early stage cervical cancer (Stage IB1-IIA) includes chemo-radiation or surgery +/- adjuvant (CT)RT and VBT if indicated. The choice of adjuvant treatment relies on identifying specific risk factors. Patients fulfilling Sedli's intermediate-risk criteria, requires pelvic radiotherapy alone and patients with high-risk Peter's criteria, require adjuvant chemoradiation. This risk-based approach helps tailor adjuvant therapies to individual patient. India reported 16,413 new cases and 6,385 deaths of endometrial cancer, with a mortality rate of 0.73%. The primary treatment for endometrial carcinoma is total abdominal hysterectomy with bilateral salpingo-oophorectomy (TAH-BSO). The Adjuvant treatment depends on risk stratification group according to ESGO/ESTRO/ESP guidelines determined through molecular-based risk stratification. Adjuvant treatment includes radiotherapy, chemotherapy, and brachytherapy. To reduce the burden of acute and late toxicity, advanced external radiation techniques like image guided intensity modulated radiotherapy (IG IMRT) are used. IG IMRT have shown their potential to reduce late toxicity in long term survivors compared to 3DCRT technique. Since January 2020, our institution (TATA memorial centre, Mumbai) has incorporated routine IG-IMRT (Image-Guided Intensity-Modulated Radiation Therapy) for treatment of cervical and endometrial cancer. However, no post-implementation assessment of treatment outcomes and potential toxicity has occurred. This is retrospective observational study aims to evaluate the clinical application of IG-IMRT. Primary aim of this study is to audit the 3 years incidence of ≥ grade II Gastrointestinal \& Genitourinary toxicities in women receiving Adjuvant IMRT (with or without chemotherapy) between January 2020 to June 2023

Primary outcome measures

• 3 years incidence of ≥ grade II Gastrointestinal & Genitourinary toxicities [Time frame: 3 years]

Secondary outcome measures (5)

• Report acute toxicity in patients receiving adjuvant RT [Time frame: 3 years]
• Assess disease free and overall survival (for cervix and endometrial cancer separately). [Time frame: 3 Years]
• Assess local regional control [Time frame: 3 Years]
• Report dose-volume parameters for prediction of late grades II-IV gastrointestinal and genitourinary toxicity [Time frame: 3 Years]
• compare outcomes with ongoing and completed institutional postoperative IMRT trials [Time frame: 3 Years]

Eligibility criteria

Inclusion criteria

• Patients more than 18 years of age at the time of diagnosis.
• All patients with confirmed histological diagnosis of cervical or endometrial cancer.
• Only those patients who have received adjuvant (chemo)radiotherapy with IMRT and/or brachytherapy at TMH/ACTREC will be included.
• Patients whose follow up information available

Exclusion criteria

• Patients with incomplete treatment details.
• Patient having residual disease post-surgery.
• Patient treated for post-operative recurrences.
• Patient who lost to follow up.
• Patients with Immunosuppressive disorder

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

India · 1 center

• Tata Memorial Center — Mumbai

Publications

• Peters WA 3rd, Liu PY, Barrett RJ 2nd, Stock RJ, Monk BJ, Berek JS, Souhami L, Grigsby P, Gordon W Jr, Alberts DS. Concurrent chemotherapy and pelvic radiation therapy compared with pelvic radiation therapy alone as adjuvant therapy after radical surgery in high-risk early-stage cancer of the cervix. J Clin Oncol. 2000 Apr;18(8):1606-13. doi: 10.1200/JCO.2000.18.8.1606. PMID 10764420
• Sedlis A, Bundy BN, Rotman MZ, Lentz SS, Muderspach LI, Zaino RJ. A randomized trial of pelvic radiation therapy versus no further therapy in selected patients with stage IB carcinoma of the cervix after radical hysterectomy and pelvic lymphadenectomy: A Gynecologic Oncology Group Study. Gynecol Oncol. 1999 May;73(2):177-83. doi: 10.1006/gyno.1999.5387. PMID 10329031
• Chopra S, Dora T, Chinnachamy AN, Thomas B, Kannan S, Engineer R, Mahantshetty U, Phurailatpam R, Paul SN, Shrivastava SK. Predictors of grade 3 or higher late bowel toxicity in patients undergoing pelvic radiation for cervical cancer: results from a prospective study. Int J Radiat Oncol Biol Phys. 2014 Mar 1;88(3):630-5. doi: 10.1016/j.ijrobp.2013.11.214. PMID 24521678
• Vandecasteele K, Tummers P, Makar A, van Eijkeren M, Delrue L, Denys H, Lambert B, Beerens AS, Van den Broecke R, Lambein K, Fonteyne V, De Meerleer G. Postoperative intensity-modulated arc therapy for cervical and endometrial cancer: a prospective report on toxicity. Int J Radiat Oncol Biol Phys. 2012 Oct 1;84(2):408-14. doi: 10.1016/j.ijrobp.2011.12.020. Epub 2012 Feb 28. PMID 22377596
• Chopra S, Gupta S, Kannan S, Dora T, Engineer R, Mangaj A, Maheshwari A, Shylasree TS, Ghosh J, Paul SN, Phurailatpam R, Charnalia M, Alone M, Swamidas J, Mahantshetty U, Deodhar K, Kerkar R, Shrivastava SK. Late Toxicity After Adjuvant Conventional Radiation Versus Image-Guided Intensity-Modulated Radiotherapy for Cervical Cancer (PARCER): A Randomized Controlled Trial. J Clin Oncol. 2021 Nov 20; PMID 34506246
• Wortman BG, Creutzberg CL, Putter H, Jurgenliemk-Schulz IM, Jobsen JJ, Lutgens LCHW, van der Steen-Banasik EM, Mens JWM, Slot A, Kroese MCS, van Triest B, Nijman HW, Stelloo E, Bosse T, de Boer SM, van Putten WLJ, Smit VTHBM, Nout RA; PORTEC Study Group. Ten-year results of the PORTEC-2 trial for high-intermediate risk endometrial carcinoma: improving patient selection for adjuvant therapy. Br J C PMID 30356126
• Correction to Lancet Oncol 2018; 19: 295-309. Lancet Oncol. 2018 Apr;19(4):e184. doi: 10.1016/S1470-2045(18)30212-2. No abstract available. PMID 29611526
• de Boer SM, Powell ME, Mileshkin L, Katsaros D, Bessette P, Haie-Meder C, Ottevanger PB, Ledermann JA, Khaw P, Colombo A, Fyles A, Baron MH, Jurgenliemk-Schulz IM, Kitchener HC, Nijman HW, Wilson G, Brooks S, Carinelli S, Provencher D, Hanzen C, Lutgens LCHW, Smit VTHBM, Singh N, Do V, D'Amico R, Nout RA, Feeney A, Verhoeven-Adema KW, Putter H, Creutzberg CL; PORTEC study group. Adjuvant chemoradi PMID 29449189

Identifiers

NCT: NCT07435623 · 4454

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗