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One Week Versus Three Week in Adjuvant Radiotherapy in Breast Cancer (HYPORTAdjuvant)

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: NCT03788213
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : January 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tata Medical Center

Brief Summary:

Background:Moderate three week hypofractionated adjuvant radiotherapy schedule is a standard care in breast cancers. A five day schedule has been demonstrated to be iso-toxic as a standard three week schedule. Recently studies have also demonstrated the safety and feasibility of simultaneous integrated boost in this setting. This randomized trial will investigate if a one-week course of hypofractionated breast radiotherapy is non-inferior to a three week course.

Aim: To determine if one-week schedule of adjuvant radiotherapy in breast cancer is non-inferior to a three week schedule.

Primary Objective: Locoregional Recurrence Rate (LRR) (Cumulative proportion of patients with locoregional recurrence) at 5 years

Secondary Objective:

  1. Overall survival (OS) (Time from randomization to death)
  2. Invasive Disease-free survival (iDFS) (Time from randomization to any invasive disease recurrence, death due to any cause or second invasive malignancy)
  3. Late adverse events (AE)
  4. Quality of Life (QoL)

Hypothesis:

  1. 1 week schedule will be non-inferior to a three week schedule for Locoregional Recurrence Rate
  2. 1 week schedule will be non-inferior to a three week schedule for OS
  3. 1 week schedule will be not result in worse late adverse events as compared to 3 week schedule
  4. Proportion of patients decrease in quality of life will not differ between the two arms at 12 months

Design: Open-label, parallel group, two arm, randomised, phase III, non-inferiority trial.

Population: Patients with breast cancer who need adjuvant radiotherapy after breast conservation or mastectomy.

Intervention: Patients will be randomized to 15 days or 5 days of radiotherapy to the whole breast or chest wall or reconstructed breast. Nodal radiation will be delivered as indicated. A simultaneous integrated boost (SIB) will be delivered to patients who need a tumor bed boost after breast cancer. The following dose schedules will be tested:

Control Group: 40 Gy in 15 fractions (alongside SIB of 8 Gy)

Test Group: 26 Gy in 5 fractions (alongside SIB of 6 Gy).

Outcomes and measures:

  1. LRR : Cumulative proportion of patients with ipsilateral Locoregional Recurrence after treatment at 5 years .
  2. OS: Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years.
  3. iDFS: Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer. Cumulative proportion reported at 5 years.
  4. AE: Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria
  5. QoL: Proportion of patients with a worse summary score in the EORTC QLQ C30 at 12 months post-treatment as compared to the baseline score.

Condition or disease Intervention/treatment Phase
Breast Cancer Female Radiation: 3 week RT Radiation: 1 week RT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, controlled, open-label, two arm, multicenter, randomized controlled trial with two parallel groups
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HYPOfractionated Radiation Therapy Comparing a Standard Radiotherapy Schedule (Over Three Weeks) With a Novel One Week Schedule in Adjuvant Breast Cancer: An Open Label Randomised Controlled Study (HYPORT- Adjuvant)
Estimated Study Start Date : January 15, 2019
Estimated Primary Completion Date : January 15, 2029
Estimated Study Completion Date : January 15, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: 3 week RT
Adjuvant Radiotherapy delivered over 3 weeks
Radiation: 3 week RT
40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.

Experimental: 1 Week RT
Adjuvant Radiotherapy delivered over 1 week
Radiation: 1 week RT
26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.




Primary Outcome Measures :
  1. Locoregional Recurrence Rate (LRR) [ Time Frame: 5 years ]
    Cumulative proportion of patients with locoregional recurrence


Secondary Outcome Measures :
  1. Overall Survival (OS ) [ Time Frame: 5 Years ]
    Time from randomization to the time of death due to any cause. Cumulative proportion reported at 5 years

  2. Invasive Disease Free Survival ( iDFS ) [ Time Frame: 5 Years ]
    Time from randomization to any disease recurrence, death due to any cause or second primary invasive cancer. Cumulative proportion reported at 5 years.

  3. Adverse Event ( AE ) [ Time Frame: 5 Years ]
    Proportion of patients with late Grade 2 or more AE as defined by the CTCAE 5 criteria

  4. Quality of Life ( QoL ) [ Time Frame: 12 months ]
    Proportion of patients with a worse summary score in the health related quality of life as measured using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ C30) at 12 months post-treatment as compared to the baseline score. The total summary score may range between 0 - 100 with higher scores indicating better health related quality of life. This score is the mean of the 13 of the 15 items of the EORTC QLQ C30 questionnaire which include the scores related to all the domains excepting the Global quality of life scale and Financial impact scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only Female with Breast Cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast cancers
  • Age > 18 years
  • ECOG performance status : 0 - 3
  • Underwent curative intent surgery for the breast cancer with complete microscopic resection either in the form of a mastectomy or breast conservation surgery
  • Adequate axillary clearance or a validated sentinel node biopsy procedure. For the purpose of this study, adequacy of the axillary clearance will be determined by a multidisciplinary tumor board and rationale for the decision documented in the case records. As a general guideline, at least 10 axillary lymph nodes need to be sampled for an axillary nodal dissection to be considered as adequate.
  • Absence of distant metastases. Patients who have high risk breast cancer as defined by a Nottingham Prognostic Index (NPI) of > 5.4 will be considered for metastatic workup in the form of a 18 FDG PET CT. Alternatively, a CT scan of the thorax and whole abdomen, and a bone scan is also allowed. Metastatic workup will also be recommended in patients with AJCC 8 T3/T4 tumors at presentation, 4 or more nodes positive after surgery (pN2 or above). Patients with low or intermediate NPI will be considered for metastatic workup on a case by case basis. Metastatic workup will also be recommended for all patients undergoing neoadjuvant chemotherapy for locally advanced breast cancers.
  • Clear margins of resection for the breast primary as defined by absence tumor on ink in the specimen if a breast conservation has been performed or excision upto the deep fascia of the pectoralis major or skin.
  • Adjuvant radiotherapy is indicated. The following patients will be considered as candidates to receive adjuvant radiotherapy:
  • All patients after breast conservation surgery or after neoadjuvant chemotherapy
  • Patients after mastectomy if any of the below:

    • T3 - T4 tumors
    • more than 3 axillary lymph nodes
    • T0-T2 tumor with 0 - 3 axillary lymph nodes with a Cambridge Score of 3 or more.
  • The SCF will be included in patients with axillary nodal involvement in pathology or in those patients who have undergone neoadjuvant chemotherapy. The internal mammary nodes will be included based on the institutional policy.

Exclusion Criteria:

  • Presence of any one of the following will exclude the patient from participation in the study:
  • Patients with pure ductal carcinomas in situ (in patients undergoing upfront surgery).
  • Patients with non-epithelial malignant conditions of the breast viz. Sarcomas, lymphomas, phyllodes tumors
  • Patients with metaplastic breast cancers
  • Presence of pathologically proven residual supraclavicular nodal metastases or residual internal mammary lymphadenopathy at time of radiotherapy.
  • Prior radiotherapy to the ipsilateral breast/chest wall or the mediastinum. Patients with synchronous / metachronous contralateral breast malignancies will be eligible for inclusion. Patients requiring bilateral breast radiotherapy are also eligible for inclusion.
  • Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
  • Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
  • Patients planned for concurrent chemotherapy during radiation therapy. Concurrent hormonal therapy or targeted therapy using anti-HER2 agents is allowed.

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): NCT03788213


Contacts
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Contact: Sanjoy Chatterjee, FRCR 9038161825 ext 7403 sanjoy.chatterjee@tmckolkata.com

Locations
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India
Sanjoy Chatterjee
Kolkata, West Bengal, India, 700160
Sponsors and Collaborators
Tata Medical Center

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Responsible Party: Tata Medical Center
ClinicalTrials.gov Identifier: NCT03788213    
Other Study ID Numbers: 2018/TMC/133/IRB/31
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tata Medical Center:
Hypo-fractionated Radiotherapy,
One week Radiotherapy
Simultaneous integrated boost
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases