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A clinical trial to compare toxicity reduction between image guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy in Cancer Cervix (PARCER) patients.

Phase III Randomized trial of image guided intensity modulated radiotherapy (IG-IMRT) and conventional radiotherapy for late toxicity reduction after postoperative adjuvant radiotherapy in CA Cervix - PARCER

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/12/003249
Enrollment
240
Registered
2012-12-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cervical cancer

Interventions

Intervention1: Tomotherapy baded IMRT : patients randomised to IMRT arm will receive external radiation through IMRT. 50Gy/25#/5weeks will be delivered over Tomotherapy. Daily MVCT imaging will be don

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 to 65 years 2. Histopathological diagnosis of carcinoma cervix with post operative intermediate or high risk feature 3. Planned for Wertheimâ??s hysterectomy or has already undergone Wertheimâ??s hysterectomy or has undergone simple hysterectomy with no evidence of residual nodes on MRI PET imaging+/- confirmatory nodal biopsy 4. No evidence of para aortic nodal metastasis

Exclusion criteria

Exclusion criteria: 1. History of multiple previous abdominal surgery placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder 2. Rectal polyps or extensive hemorrhoids

Design outcomes

Secondary

MeasureTime frame
o To identify small bowel dose volume characteristics that predict for grade II to grade IV late toxicity o To identify preoperative imaging features that predict for local and distance recurrence following recurrence following pelvic radiotherapy (+/- chemotherapy) o To compare QOL score between conventional RT and IG-IMRT. Timepoint: 2-3 years of complete accrual

Primary

MeasureTime frame
To compare late small bowel grade II-IV toxicity of Tomotherapy based pelvic IG-IMRT and Conventional Pelvic RTTimepoint: final analysis : 7 years from continuation of trial. Interim analysis: when median follow-up of 50% of patients reaches 18 months.

Countries

India

Contacts

Public ContactSupriya Chopra

Tata memorial Centre ACTREC

schopra@actrec.gov.in27405510

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026