Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer (DEPICT)
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|ClinicalTrials.gov Identifier: NCT01230996|
Recruitment Status : Active, not recruiting
First Posted : October 29, 2010
Last Update Posted : August 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Locally Advanced Cervical Cancer||Drug: Cisplatin Radiation: Intensity-modulated radiation therapy Procedure: Intracavitary brachytherapy||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II, Multi-Center Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer|
|Actual Study Start Date :||July 2010|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: Dose escalation study
This is a dose escalation study of IMRT for women with locally advanced cervical cancer. Three dose levels will be investigated, (although, the first dose level is considered to be the equivalent to a standard pelvic dose with parametrial boost). Before moving to the next dose level it must be confirmed by the Chief Investigator that the Maximum Administrable Dose (MAD) has not been met in the previous dose level (see section 6.3). If MAD is reached before dose level 3 the study will stop. All patients enrolled on the study will undergo the same procedures at the same time points, regardless of the dose level they are being given (see section 5).
Each patient will also receive chemotherapy with a drug called cisplatin, which is given intravenously through a drip in the arm once a week during their 6 week radiotherapy treatment. Again this is standard treatment for any patient with cervix cancer.
Radiation: Intensity-modulated radiation therapy
Patients in this trial will receive radiotherapy to the pelvic area with additional chemotherapy (chemoradiotherapy). This is the standard treatment for cervix cancer and will be almost identical to patients not taking part in this study. As patients in the study will be treated with IMRT, the total radiation dose will be slightly higher but without increasing the dose to normal tissue in the pelvis. This will mean the number of radiotherapy treatments that each patient receives in the study is between 27 and 30 compared with the usual 28. Each patient will undergo 6 weeks of radiotherapy treatment and must attend the radiotherapy department hospital once daily (Monday to Friday) over 6 weeks. Each treatment lasts for approximately 10 15 minutes. This is exactly the same as standard practice if patients were not participating in the trial.
Other Name: IMRT
Procedure: Intracavitary brachytherapy
Intracavitary brachytherapy Intracavitary brachytherapy will be given towards the end of external beam radiotherapy usually weeks five and six. This is routine treatment and will be given according to local practice As is the convention patients will be reviewed weekly (more frequently if necessary) by their study doctor and will have weekly blood tests to measure full blood count and urea and electrolytes.
- Grade 3 gastrointestinal toxicity at 6 months as defined by CTCAE v 3.0 [ Time Frame: 6 months ]
- Response rate assessed radiologically at 3 and 12 months [ Time Frame: 3 and 12 months ]
- Local control of the disease at 2 years [ Time Frame: 2 years ]
- Late toxicity at 2 years as defined by CTCAE v 3.0 [ Time Frame: 2 years ]
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): NCT01230996
|Saint Bartholomew's Hospital|
|London, England, United Kingdom, EC1A 7BE|
|London, England, United Kingdom|
|Royal Marsden - London|
|London, England, United Kingdom|
|Sheffield Teaching Hospitals NHS Foundation Trust|
|Sheffield, United Kingdom|
|Principal Investigator:||Melanie Powell||Barts & The London NHS Trust|