KORTUC Phase II - Intra-tumoural Radiation Sensitizer in Patients With Locally Advanced/Recurrent Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03946202|
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Hydrogen Peroxide||Phase 2|
Aim: To test a slow release gel containing a commonly available and inexpensive chemical (hydrogen peroxide) for safety and activity in sensitizing large cancerous lumps in the breast or armpit to a standard 3-week course of radiotherapy in patients with locally advanced or recurrent breast cancer.
Background: Laboratory research and initial clinical trials conducted in Japan raises the possibility that a simple and inexpensive treatment based on a very dilute (0.5%) hydrogen peroxide injected into cancers under local anaesthetic greatly increases the effectiveness of standard doses of radiotherapy. The side effects appear to be limited to mild/moderate discomfort at the injection site for up to 24 hours in one-third of patients. Rapid, complete and durable tumour disappearance has been reported in 49/55 bulky breast cancers in Japanese women treated using this approach, a response that is at least 3 times the success rate of radiotherapy alone in our own patients and in a contemporary Japanese control population. The inventor, Prof Ogawa of Kochi University, has approached the investigators to lead the further clinical evaluation and commercial development, starting with the proposed early phase trials testing safety and anti-cancer activity described below.
Design and methods: After numbing the skin with local anaesthetic, a specialist doctor (radiologist) or trained radiographer will use ultrasound to guide the injection of a small volume of dilute (0.5%) hydrogen peroxide solution into the tumour twice a week during 3 weeks of standard radiotherapy. The drug is suspended in a natural gel (1% sodium hyaluronate, licensed for treating stiff knee joints) that ensures its slow release over 48 hours. The injection procedure lasts for 10-15 minutes altogether. Tiny oxygen bubbles are released from the hydrogen peroxide which help the radiologist guide the injection of drug to the proper places under the skin. We have recently completed a safety study confirming the mildness of side effects in 12 patients, and we now wish to test activity against cancer in a randomised controlled trial in 184 patients. Patients participating in Phase II will either have standard radiotherapy or the same radiotherapy plus the drug under test. Neither the patient nor the doctor will choose who has which treatment, which is allocated randomly.
Patient and public involvement: Independent Cancer Patient Voice, a patient advocate group in the field of cancer, is collaborating with the investigators on the research plan, commenting and advising on the content and clarity of the written proposal. This group plays a prominent role in promoting UK clinical research, being represented on the Trial Management Groups of several national randomised cancer clinical trials.
Dissemination: The results of this study will be presented at scientific meetings and at meetings of the patient advocate group in order to judge if the results for safety and activity are promising enough to justify taking the research further.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomised Phase II Trial Testing Efficacy of Intra-tumoural Hydrogen Peroxide as a Radiation Sensitiser in Patients With Locally Advanced/Recurrent Breast Cancer|
|Actual Study Start Date :||June 16, 2020|
|Estimated Primary Completion Date :||June 16, 2025|
|Estimated Study Completion Date :||June 16, 2025|
Experimental: Radiotherapy + radiation sensitiser
Patients randomised to the test group will receive standard radiotherapy for breast cancer + a radiation sensitiser
Drug: Hydrogen Peroxide
No Intervention: Radiotherapy alone
Patients randomised to the control group will receive standard radiotherapy for breast cancer alone
- Complete tumour response 12 months post-radiotherapy assessed by MR [ Time Frame: 12 months post radiotherapy ]
- Proportion of patients withdrawing from study due to pain from intratumoural injections recorded at 2-week post-RT visit [ Time Frame: During radiotherapy, an average of 3 weeks ]
- Patients achieving pathological complete response following tumour resection prior to the 12-month MR assessment will be included in a sensitivity analysis of the primary endpoint [ Time Frame: During 24-month follow up period ]
- Proportion of patients with partial response and stable disease [ Time Frame: 12 and 24 months post radiotherapy ]
- Planned/unplanned tumour excision and pathological response recorded at post-RT follow-up visits [ Time Frame: During 24-month follow up period ]
- Local progression-free survival at 12 and 24 months [ Time Frame: 12 and 24 months post radiotherapy ]
- Overall survival at 12 and 24 months [ Time Frame: 12 and 24 months post radiotherapy ]
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): NCT03946202
|Contact: Lone Gothard||+44(0)email@example.com|
|Contact: Claire Lucy||+44(0)firstname.lastname@example.org|
|The Royal Marsden NHS Foundation Trust||Recruiting|
|Sutton, United Kingdom, SM2 5PT|
|Contact: Lone Gothard 02086613460 email@example.com|
|Contact: Claire Lucy 02086613273 firstname.lastname@example.org|
|Principal Investigator: Navita Dr Somaiah|
|Sub-Investigator: Anna Dr Kirby|
|Sub-Investigator: Imogen Dr Locke|
|Sub-Investigator: Ross Dr Gillian|
|Principal Investigator:||Navita Somaiah||The Institute of Cancer Research & The Royal Marsden NHS Foundation Trust|