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Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix (PARCER)

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ClinicalTrials.gov Identifier: NCT01279135
Recruitment Status : Completed
First Posted : January 19, 2011
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Supriya Sastri (chopra), Tata Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Cervix Radiation: Conventional Radiation Radiation: Tomotherapy based IGRT Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Masking Description: No masking. This is a open-label study.
Primary Purpose: Treatment
Official Title: Phase III Randomized Trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for Late Toxicity Reduction After Postoperative Radiotherapy in Ca Cervix.
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : January 31, 2020

Arm Intervention/treatment
Active Comparator: Conventional RT
Patients in this arm will receive conventional radiation with or without chemotherapy
Radiation: Conventional Radiation
Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

Experimental: Tomotherapy based IGRT
Patients in this arm will receive Tomotherapy based IGRT with or without chemotherapy
Radiation: Tomotherapy 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




Primary Outcome Measures :
  1. Late bowel toxicity ≥ Grade II [ Time Frame: Median follow up of 3 years ]
    Time to event and severity of late bowel toxicity are assessed


Secondary Outcome Measures :
  1. To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity [ Time Frame: 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

  2. To evaluate acute toxicity difference in two study arms using CTCAE version 3.0 [ Time Frame: 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.

  3. Preoperative functional imaging features that predict for local and distant recurrence will be identified [ Time Frame: 3 years after completion of accrual ]
    Images acquired pre-operatively are analysed for features that predict local and distant recurrence.

  4. To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30 [ Time Frame: 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.


  5. To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24 [ Time Frame: 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01279135


Locations
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India
Advanced Centre for Treatment, Research and Education in Cancer, Tata Memorial Centre
Navi Mumbai, Maharashtra, India, 410210
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
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Principal Investigator: Supriya Chopra, MD,DNB ACTREC, Tata Memorial Centre
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Supriya Sastri (chopra), Associate Professor, Tata Memorial Hospital
ClinicalTrials.gov Identifier: NCT01279135    
Other Study ID Numbers: Project 803
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Keywords provided by Supriya Sastri (chopra), Tata Memorial Hospital:
IGRT,Postoperative, Cervix, Late toxicity, Bowel