Have you or your loved ones been diagnosed with cancer cervix?

You may be eligible to participate in a cancer cervix clinical trial.

Have you or your loved ones been diagnosed with cancer cervix? You may be eligible to participate in a cancer cervix clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Cancer Cervix Clinical Trial in Navi Mumbai Maharashtra

NCT01279135 | Phase 3 | Interventional

Have you or your loved ones been diagnosed with cancer cervix?

You may be eligible to participate in a cancer cervix clinical trial.

Have you or your loved ones been diagnosed with cancer cervix? You may be eligible to participate in a cancer cervix clinical trial.

Completed

Female

18 Years +

This study has recruited 300 Participants

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

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Details for the study

Brief Title

Tomotherapy vs Conventional Radiation for Adjuvant Pelvic RT in Ca Cervix

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.

Brief Summary

The study tests Tomtherapy based Image Guided Radiation against conventional radiation<br /> 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

Treatments and/or Procedures

Conventional radiation

Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks

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

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Late bowel toxicity ≥ Grade II

Time to event and severity of late bowel toxicity are assessed

Median follow up of 3 years

Secondary

To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity

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

Median follow up of 3 years

Secondary

To evaluate acute toxicity difference in two study arms using CTCAE version 3.0

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.

Within 90 days

Secondary

Preoperative functional imaging features that predict for local and distant recurrence will be identified

Images acquired pre-operatively are analysed for features that predict local and distant recurrence.

3 years after completion of accrual

Secondary

To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30

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.

3 years from completion of accrual

Secondary

To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24

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.

3 years from completion of accrual

Study 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.